Alliance for Patient Safety

Preface

Errors in medical diagnosis and treatment, which cause damages to patients and occur in both, hospitals and medical institutions in the community, are one of the challenges that the medical systems worldwide are facing[1].  From the professional literature it transpires that the term "medical error" includes: an unintentional doing or action that did not achieve its planned objective; failure to complete a planned action (execution error); use of an unsuitable plan to achieve the objective (error in planning) or deviation from the treatment process which may (or may not) cause damage to the patient[2]. According to estimates, errors as a result of medical activity are the third cause of death in the United States, responsible for the deaths of some 251 thousand people a year on average. Nonetheless, as per the investigators this estimate is an underestimation of the actual scope of the phenomenon[3].

The rules of ethical conduct of the Medical Association in Israel relate to the obligation of the physician to act in order to prevent such incidents and it has been determined, inter alia, that: the physician will assist, to the best of his ability, to protect the safety of the patient and prevent errors in the medical treatment; the physician will report to the appropriate professional body about errors occurred in the medical treatment; the physician will respect the rights of the patient to receive reliable and complete information concerning the circumstances of the medical treatment he received, including error that may have taken place during the course of this treatment, if it has an implication on the medical condition of the patient or on the continuation of his medical treatment; the physician will explain the nature of the error that occurred in his treatment to the patient, the steps taken to correct it and the processes executed in order to prevent making this error again in the future[4]. In addition, clause 21 of the Patient Rights Act 5756 – 1996 determines the setup of an investigation committees for checking exceptional event concerning the provision of medical treatment whose objective is to clarify what has happened to the patient during the medical treatment, draw conclusions, correct the flaws and to locate those who are responsible for them through checking whether there is a need to initiate a disciplinary or any other process.

In the State's Comptroller report 62 of 2011 the Comptroller mentioned few factors which might bring about failures and errors in the medical system, among them: Risk factors, some of which are not under the control of the medical system (such as unpredicted response of the patient to the medical treatment);  work burden put on the treating staff or the lack of environmental conditions enabling the process and input of large data involved in the treatment of the patient; errors of the treating staff, errors in judgment and human errors; negligence in the medical treatment which does not reach disciplinary violation; severe negligence which contains disciplinary violation; criminal negligence which in fact is a criminal violation[5].

According the State Comptroller, "only a fraction of the total exceptional events and the medical failures are emanating from negligence"[6]. That is, not every error or medical failure is a result of medical negligence, however in the Comptroller's report the scope of these occurrences in Israel was not mentioned.

Notwithstanding, according to the State Comptroller, in the years that preceded this report a significant and constant increase occurred in the scope of the financial demands and claims against the state submitted to the Courts and insurers due to medical negligence in Israel. The State Comptroller attributes this increase not necessarily to the increase of the scope of medical injury due to negligence, but, inter alia, to the increase in awareness within the public to medical negligence and to standing on its rights to submit claims, as well as the increase in the number of lawyers[7]. This trend has led the state to setup two committees to handle the issue of medical negligence. The committee for examination of the responsibility for damage in the medical treatment, headed by judge Dr. Gabriel Kling, which has submitted its recommendations to the Director General of the Ministry of Health in 1999, and The inter-disciplinary committee for examination of the ways to reduce the public spending due to medical negligence headed my Ms. Tana Shapnitz which has submitted its recommendations to the Ministry of Justice in 2005. These committees dealt with the various aspects of the medical negligence issue, and among them the increase of the legal claims due to this negligence. However, even with the data brought fourth in these reports, as well as the stated State Comptroller report, it is not possible to learn the scope of the medical negligence occurrences in Israel over time.

We wanted to introduce in this document the scope of the medical negligence in Israel and for that purpose we approached various relevant bodies, among them the Ministry of Health, the Ministry of Finance, the Medical Association of Israel, the Central Bureau of Statistics, the Israeli Police, The Israel Bar Association, the Management of the Courts , and the Nurses Association. From the information received from the Ministry of Health and the various bodies (except for the Nurses Association that until now has not replied to our application) it transpires that there is no complete information about the number of medical negligence incidents in Israel, but only partial data which is insufficient to determine and reflect the scope of the actual phenomenon.

In the first chapter of the document we shall introduce the Ministry of Health’s definitions of medical negligence as well as the partial data about the prevalence of the phenomenon in Israel, the sources of which are in the Management of the Courts, the Ministry of Health, The Ministry of Finance and the Central Bureau of Statistics. In the second and third chapters we shall introduce the various bodies entrusted with the examination of exceptional occurrences in the medical treatment in the Ministry of Health (The Medical Administration, the Public Service Commission for the Medical Professions and the Disciplinary Unit) and the data about deaths and incidents requiring report to the Ministry of Health and examining the complaints due to medical negligence by the Office. In the fourth chapter we shall introduce the data of the Ministry of Health and the Ministry of Finance concerning the economic burden due to medical negligence claims against governmental medical institutions and in the last chapter of the document we shall introduce the model used in Denmark for the handling of medical negligence claims against the health system.

1. Medical Negligence Definition and Partial Data about the Phenomenon in Israel

Given that not every error or medical fault is medical negligence, the Knesset Research and Information Center firstly approached the Ministry of Health with the question how the office defines "medical negligence". In response to our inquiry the Ministry of Health replied that medical negligence is "providing medical treatment with deviation from reasonable level of caution"[8] and added that "there is no legal definition for the term medical negligence, however it is conceived as some kind of negligence".

The Office also advised that there are different types of medical negligence which are examined according to different fields of the law[9] [the bold face is not in the original] as follows:

In the civil field, as stated by the Ministry of Health, civil claims submitted due to the tort of negligence are ascribed to the Law of Torts. These claims enable an awarding of a financial compensation in the case where it is proven that damage was done due to the negligent act and when a causal connection had been established between the act and same damage[10]. The negligence injustice is defined in clauses 35 and 36 of the Civil Torts Ordinance (new version) 5728 – 1968".[11] According to clause 35 of the Civil Torts Ordinance negligence is defined as a case in which "a person did a deed that a reasonable person would not have done it under same circumstances, or have not done a deed that a reasonable and intelligent person would have done under same circumstances, or that in a certain occupation did not use the skills or has not taken a degree of caution, that a reasonable, intelligent and qualified person in that occupation would use or take an action in same circumstances- than it is negligence; and if has neglected as said in relation to another person, towards whom under same circumstances he is obliged not to behave as he did, than it is negligence, and the party causing through his negligence damage to other person is doing injustice". According clause 36 of the Civil Torts Ordinance" the obligation stated in clause 35 is imposed towards every person and every asset owner, every time that a reasonable person should have seen in same circumstances in advance that they may during the customary proceedings of things to be injured from deed or a failure to act interpreted in same clause."[12]

In the criminal field: the Ministry of Health has indicated, that negligence alone is not enough to impose criminal responsibility, but only if there is a specific instruction in the Law referring to the violation under discussion here. As stated by the Office, criminal violations that are negligence violations per say, do not exist, but violations that could be performed through negligence, such as: causing death by negligence, causing damage by negligence and more. In the Ministry of Health they referred to clause 338 (a) (7) of the Penal Code 5731 – 1977 which defines reckless action and negligence in medical treatment in the following manner: "doing one of the following in a hasty or negligent way in which it may put at risk a person's life or cause him injury, his sentence is – three years of imprisonment…(7) Providing a medical or a surgical treatment to a person to whom he has obliged oneself to take care of". As stated by the Ministry of Health, if there is sufficient evidence to achieve public interest, then a bill of indictment is submitted in the criminal field against the medical treatment provider who acted negligently, whereas based on the bill of indictment and after the termination of the criminal process a disciplinary process could be opened as well against the accused.[13]

In the disciplinary field: the Ministry of Health stated that a State Attorney's guideline 14.2 on the issue of criminal and disciplinary proceedings against physicians or other medical professions due to professional negligence exists (last updated, as stated in it, on 1 / January / 2003),[14]  which includes instructions on how to act if there is a suspicion to medical negligence. As stated by the Office, at times disciplinary complaint would be submitted to the Minister of Health even prior the termination of the criminal proceedings (in case such proceeding are taking place) where according clause 44a of the Medical Physicians Ordinance [new version] 5731 – 1976 a physician's license can be suspended for a period of up to six months if there is a suspicion that he caused in severe negligence damage or death to a person. This suspension can be prolonged when needed for additional six months.[15]

There is no data held by of the Ministry of Health on the scope of the medical negligence phenomenon in the entire medical system in Israel and including the number of deaths occurrences as a result of medical negligence, and this according to the Ministry is due to the different definitions to the term medical negligence as specified above.[16] The Ministry of Health added and explained that "damaging negligence is determined by means of a Court sentence in which framework the Court panel determines that the treating team has acted in negligence and the patient has been injured as a result. In most cases these are claims submitted years after the alleged negligence occurrence had happened and it brings about real difficulty in locating files of this nature with the passing of years after the termination of the civil proceedings" [the bold face is in the origin].[17] Nonetheless the question is asked whether there is no room to act for the gathering of this information in order that it will be possible to get a complete picture whereas the scope of the medical negligence in Israel . To this it should be added that already in 2011 the State Comptroller called the Ministry of Health "to gather information from a lot of activity done in the Courts in the field of medical negligence".[18]

According the Office they have hold of reports about deaths and exceptional occurrences that the medical institutions are obliged to report to the Ministry of Health as per the Medical Administration circular no. 11/2012 concerning the reporting obligation of a medical institute about deaths and exceptional occurrences dated the 9 / May / 2012 on which we shall further elaborate later in the document.[19] However, as stated earlier not every exceptional occurrence is negligence and therefore it cannot be learned from same about the number of medical negligence occurrences.

Due to lack of data about medical negligence in this chapter we shall introduce data conveyed to us from different sources from which it can only be partially  gleaned about the scope of the phenomenon. We shall present below the data of the Management of the Courts about the scope of the civil claims submitted due to medical negligence, the data of the Ministry of Health and the Ministry of Finance on the number of the claims due to medical negligence submitted to the Courts against governmental medical institutions only and the data of the Central Bureau of Statistics of Israel about deaths where medical negligence could have been involved. We should note,, that the Knesset Research and Information Center has also approached the Israeli Police with the question about data and information it may hold in regards to the number of criminal files opened due to medical negligence in the years 2005 – 2016, however we were answered that there is no data on the issue.[20]

1.1 Management of the Courts data about the scope of civil claims submitted due to medical negligence

In response to the application of the Knesset Research and Information Center the Management of the Courts sent us data about the number of civil claims due to medical negligence submitted against medical institutions in Israel in the years 2010 – 2015 and data about the files in which Court sentence was given.[21]

Table no. 1 – Management of the Courts data about the number of civil claims submitted due to medical negligence against medical institutions in Israel and on the number of claims in which sentence was given in 2010 – 2016[22]

From the data presented in the table above it transpires that in the years 2010 – 2016 overall 10,694 civil claims were submitted due to medical negligence against different medical institutions in Israel, where it can be seen that during the years an increase occurred in the number of claims from 1,109 claims in the year 2010 to 1,985 claims in the year 2015. Further, it transpires from the data that in said years a Court sentence was given in 8,753 claims in rulings in matters of medical negligence – nonetheless, it cannot be deducted from this data about the number of claims per year in which a Court sentence was given since at least in part of the cases these sentences were given about cases submitted in previous years. As stated above, we do not hold any data in regards to how many of the claims were found justified.

1.2. Ministry of Finance and Ministry of Health data on the number of claims due to medical negligence in governmental medical institutions

The Knesset Research and information Center approached the Ministry of Health and the Ministry of Finance with the question what was the number of claims due to medical negligence which were submitted to the Courts in every one of the years 2005 – 2016 against the entire medical institutions in Israel. In response to our request both offices replied that they have data concerning governmental medical institutions only as received from Inbal Insurance Co. Ltd. that is to say, the data does not include the number of claims due to medical negligence in the health maintenance organizations (HMOs) and the hospitals owned by them, as well as in other public health institutions and private health institutions.

In light of the above the presented data is partial data only, since according to the data for the years 2015 – 2016 out of 44 general hospitalization institutions, 11 (including governmental – municipal hospitals) are state owned, and these contain less than half of the hospital admission beds for general hospitalization; out of 12 mental health hospital, 8 are state owned, and these contain 82% of the hospital admission beds for mental health in Israel; out of 296 geriatric institutions, only 5 are state owned, and these contain only 7% of the geriatric hospital admission beds in Israel.[23] It should be noted that the State Comptroller has commented about these numbers to the Ministry of Health in 2011 and according to the State Comptroller "in the audit it was found that the Office [at the Ministry of Health] does not receive copies of the claims submitted against public and private hospitals and against the health maintenance organizations (HMOs) unless a copy is sent to the Public Service Commission [Ministry of Health] as well, and that in contrast to claims for medical negligence submitted against government owned hospitals. Moreover, due to the fact that for a large part of the medical negligence cases civil claims are submitted directly to the Courts and no complaint is submitted to the Complaints Commissioner in the Office. In addition the claims can be deliberated in the Courts for many years to come, and even after their termination their existence will not become known to the Office. It may be therefore be the case that severe system failures which caused exceptional occurrences and damages, will not be corrected."[24]

Next we shall introduce the data of the Ministry of Health and Ministry of Finance on the number of claims due to medical negligence which were submitted against the governmental medical institutions in each of the years 2005 – 2015.[25]

Table no. 2: Ministry of Health and Ministry of Finance data on the number of claims due to medical negligence submitted to the Courts against governmental medical institutions, segmented according type of insured (type of medical institution) 2005-2015[26]

As it transpires from the data of the table above, in the years 2005 – 2016 some 8,372 claims were submitted to the Courts due to medical negligence against the governmental medical institutions. In general in the years 2005 – 2016 a constant increase occurred in the number of claims due to medical negligence against the governmental medical institutions from 597 claims in the year 2005 to 1,008 claims in the year 2015.

Furthermore, it can be indicated that the majority of the negligence claims submitted in same period were submitted against the hospitals for general hospital admission (about 82% of total claims); about 13.4% of the claims were submitted against the health bureaus; about 3.3%of the claims were submitted against mental health hospitals; about 0.75% of the claims against the Ministry of Health and about 0.5% of the claims were submitted against geriatric institutions. Nonetheless, it is important to remember that in the 11 state owned hospitals for general hospitalization there are over 7,000 bed hospital admission beds, in comparison to 2,900 in the governmental hospitals for the mental health and about 1,800 in the governmental geriatric hospitals.[27]

It further transpires from the above table that in the stated period an increase occurred in the number of claims due to medical negligence submitted against every one of the institutions detailed in the above table (with the exception of the Ministry of Health in which a decrease occurred in the number of claims between the years 2013 – 2015). So for instance the number of claims against the general hospitals increased between the years 2005 – 2015 by some 45% from 521 claims in 2005 to 755 claims in 2015 and the number of claims against the health bureaus increased by almost five times from 51 claims in 2005 to 225 claims in 2015. We have no explanation in regards to this increase. In addition it should be noted that no information has been conveyed to us in regards to the amount of claims that were closed and in how many of them compensations were paid.

1.3. The Central Bureau of Statistics data on Deaths in which Medical Negligence might have been involved

Due to the fact that the Ministry of Health holds no data on the number of deaths attributed to medical negligence, the Knesset Research and Information Center approached the Central Bureau of Statistics (hereinafter: the CBS) with the question whether information could be produced out of its data about the number of deaths in each one of the last ten years, which may have occurred due to medical negligence. Prior to introducing the products of the special processing which was done for us in the CBS we shall highlight, that while it is possible to get the impression from the aforesaid data about the total deaths occurrences in which medical negligence might have been involved, it does not constitute certain data on the scope of deaths as a result of medical negligence, since in the rules of the international classification of the diseases (10^th edition) (The International Statistical Classification of Diseases and related Health Problems –Tenth Revision) with which the CBS made use (and in all the member states of the World Health Organization),[28] there is no death cause defined as "negligence" or causes which it is possible to learn directly and unequivocally from them about occurrence of negligence.[29]

Within the framework of symbolization of the death causes according to the international rules of diseases classification (ICD-10) the basic cause of death is selected, that is the cause which had begun the chain of co-morbidities which have led to the death of the patient, and it is used for statistical needs. In addition, in the CBS they also symbolize all the causes or situations recorded in the death certificate (also called multiple symbolizing). The CBS noted that symbolizing the death causes is based on what has been written in the death certificate only, however the CBS corrects the basic cause of death if additional information is received from external body (Israeli Police files, the Institute for Forensic Medicine, the Social Security, IDF) in cases of road accidents, suicide, murder, birth defects, acts of terrorism, IDF fallen soldiers and infant mortality.[30] Information about death occurrences examined or investigated in hospitals or in the health bureaus does not reach the CBS.[31]

The CBS has noted that they have not encountered cases in which the word negligence or medical malpractice were indicated in the death certificate. According to them, there are few cases every year, if at all, of notices in which it had been recorded that the complication was from an iatrogenic source, i.e. caused by the medical team and these cases are usually coded as "mishap / complication during surgery or procedure". Out of all this transpires according to the CBS, that the death notifications is a very limited source for learning on the number of deaths due to medical negligence and information based on this source in regards to the issue of medical negligence leads in their estimate to meaningless underestimation of the issue.[32]

However, the CBS indicated that there are codes which could hint on an occurrence of negligence. In response to our request for special processing of this data the CBS checked groups of codes included in two

chapters of the classification mentioned above; The first group are codes included in chapter 20 "External causes to mortality or morbidity" in which there is a sub group defined as "Complications of medical and surgery care" part of which may, according to the CBS, to hint about negligence, however, as stated above, not in proven way. According to the CBS these codes can appear as the basic death cause and can appear also in the multiple symbolizing. This group includes the following four sub-groups:

1. Adverse effects of medications or biological substances
2. Mishaps (complications) during surgeries and medical care;
3. Mishaps (complications) associated with the use of medical device for diagnosis and care;
4. Complications in surgeries or procedures or an unexpected reaction of the patient, without mentioning mishaps

The CBS indicated that out of the four aforesaid sub-groups, the relevant groups in regards to our a them reference to mishap, however they conveyed to us the data in regards to all the four groups.

The second code group examined by the CBS was the code group included in chapter 19 under the classification "Injuries or poisoning and other damages which are the result of external cause". These include cases in which the basic cause of death is an external cause (such as road accident), however injuries or poisoning and other damages which are the cause of an external cause can appear in the multiple symbolizing.

According to the CBS, the two sub-groups in chapter 19 which might testify on negligence are: poisoning from medicines and biological substances and complications of surgeries and medical treatment. Nonetheless, according to the CBS there is no reference to "mishap" in these codes and therefore it is not possible to know what was the source of the complication.

In the next table we shall introduce the number of deaths classified in the CBS data in the four sub-groups of chapter 20 and the groups of chapter 19, where according to the CBS, the summary of these occurrences, is the maximum number of occurrences in which it is possible to get a hint from the death announcement that there was medical negligence, since every death appears in the table only once.[33]

Table no.3: CBS data on the maximum number of occurrences from which it is possible to get a hint from the death announcement that there might have been medical negligence 2005 – 2014[34]

The data presented in the above table indicates that according to the death announcement ,in the years 2005 – 2016, it might have been that there was medical negligence in 1,892 cases, (out of which, about 29% cases in which it is the said basic cause). If we relate only to the two mishaps codes – mishaps during surgeries/procedures and mishaps with medical device then the number at hand is 42 of the cases (36 cases where the code appears as the basic cause and seven cases where the code appears in the multiple symbolizing). We should indicate that the annual number of deaths in Israel on average stands at about 40,000 deaths.[35]

In addition to this data, the CBS indicated that cause of death named as blood infection could also derive from medical negligence, due to hospital acquired infection occurring in the course of a procedure conducted under inappropriate conditions. We would like to note that in 2014 the number of deaths from blood infection as basic cause stood at 1,864 deaths. According to the CBS, the number of deaths from blood infection increased in the recent years, and today the number of deaths from this cause in Israel is one of the highest in the world. About 4% of the deaths are the result from blood infection and in about 27% of the deaths this cause appears as part of the reasons to the death, although not as basic cause.[36] In hospital deaths the percentage is even higher and in 2014 it stood on about 37.5% from all the deaths in hospitals. The CBS emphasizes that according to the cause recorded on the death certificates there is no way of knowing what is the source of the infection and whether it is a hospital acquired infection or whether it is the result of medical negligence and that the topic is examined and investigated in the hospitals and by the Ministry of Health.[37]

In summary, in this chapter we have presented the partial data existing on medical negligence in Israel, from which it transpires that in the years 2010 – 2016 some 10,694 civil claims were submitted to the Courts due to medical negligence, however it is not clear how many of them were found justified; 8,372 claims were submitted against governmental medical institutions only, however it is not clear to in how many of them compensations were paid; and according to the classification of death certificates by the CBS in the years 2005 – 2014 in some 1,892 cases it had been possible to get a hint from the death certificate that medical negligence might have occurred, however as stated above, according to the CBS the death certificates are very limited source to learn from about the number of death cases from medical negligence and basing the assessments on this source in regards to medical negligence is leading according to their evaluation to a meaningless underestimation of the issue.

Due to lack of data on the number of the medical negligence cases ,the question is asked what is the number of special cases or events during medical care in Israel, how these cases are examined by the Ministry of Health and in how many were suspected or medical negligence was found, and we shall engage in these in the following chapters.

2. The bodies entrusted with examining special events in medical treatment at the Ministry of Health

According to the Ministry of Health it holds reports about deaths and special events on which the various  medical institutions are obliged reporting to the Ministry of Health, in accordance with the Medical Administration circular 11/2012 in regards to compulsory report by medical institution on deaths and special events dated 9 / May / 2012, in addition to reports on events which do not require reporting as per stated procedure.

Notifications about deaths and special events are received at the Medical Administration in the Ministry of Health,[38] and we shall review the manner in which the Administration handles these notifications below, the cases passed on for the handling of the Public Complaints Commissioner for the Medical Professions and the Disciplinary Court Unit in the Ministry of Health.

2.1 The Medical Administration at the Ministry of Health

The Medical Administration at the Ministry of Health, the responsible body, inter alia, on the area of medical regulation and compliance of the healthcare system, is the entrusted body for receiving the medical institutions reports in accordance with the Circular in regards to deaths and special events. Upon receipt of a report, the Medical Administration commences a process of investigation of the case and carries out any required completions of materials about the discussed case according to need and circumstances. After completion of the required details a decision is made whether a further inquiry and / or a more in-depth inquiry is called for, and in cases where the answer is yes, the details of the case are passed to the Public Complaints Commissioner for the Medical Professions in the Ministry of Health (hereinafter Public Complaints Commissioner) who handles complaints in the clinical areas.[39]

As it transpires from the Ministry of Health’s website, the decision on transferring the case for investigation by the Public Complaints Commissioner is made in cases where a suspicion arises of an unethical behavior or a deviation from reasonable professional standard within the framework of public and private medicine  versus a medical institution or health professional (physician, nurse, midwife, a geriatric institution, mental health clinic etc.).[40] We should note, that with the exception of the cases received for handling by the Public Complaints Commissioner, according to the Ministry of Health’s website, applications to this body may also arrive from office holders in the police and the State Attorney's office, as well as from the public, and the commissioner may open an inquiry on its own initiative following civil claims and even following news from the media.[41]According to the Ministry of Health, all the claims on the issue of medical negligence received in the Ministry of Health from the various bodies are immediately directed for handling by the Public Complaints Commissioner of the Medical Professions.[42]

We should note, that concurrently with the inquiry conducted by the Medical Administration in regards to every report on death and special event received at the Medical Administration, these reports are conveyed by the administration also for systemic handling in the Treatment Safety Array of the Ministry of Health, which handles promoting the issue of safety treatment since 2011.[43]

2.2. Public Claims Commissioner for the Medical Professions

On the Ministry of Health’s website it is mentioned that the Public Claims Commissioner is authorized to execute judgment with regards to the manner in which a claim is investigated according to the circumstances of the case. We should note, that once commissioner’s work is completed it passes the investigation’s conclusions and its recommendations to the claiming party, to the investigated bodies, and if systemic and personal recommendations exist, these are  also conveyed to the Director General of the Ministry of Health.[44] Below we shall introduce the process’ handling stages by the commissioner of an application, as detailed on the Ministry of Health’s website:

1. Receipt of an application in writing, its study, examining whether it is in the scope of investigation by the commissioner and its input in the computerized system;
2. Sending confirmation of receipt to the applicant or notification that the complaint was passed to another handling body (not indicated which body). As stated in the Ministry of Health’s website, a confirmation on the application receipt and a short briefing about expected response ,will be provided within two weeks. When the duration of the handling of the application changes according to the nature of the claim and in accordance with the need to setup an inquiry committee,[45] about which we shall elaborate later;
3. Gathering information about the case (e.g. medical records) and sending the application to the party against which the claim was submitted [the defendant]. In case no response is received from the defendant within reasonable time (which duration was not indicated online), a reminder is sent to the defendant;
4. Concurrently, the medical and forensic information gathered by the commissioner is examined, and a decision is made to act in one of the following ways:
5. Ending the handling of the application and response to the applicant;
6. Ending the handling of the claim and its transfer to another handling body (not indicated who are the possible bodies);
7. Continuation of the inquiry vis-a-vis the defendant;
8. Receipt of an expert opinion

5. Summons of the defendant and/ or the applicant for a clarification discussion
6. Setup of a an investigation committee

According to the procedures of the Ministry of Health, the setup of an investigation committee will be performed, as a rule, for the investigation of the following events:

• An exceptional event^[46] which ended with a severe medical damage^[47] or anticipated to be severe to the patient and it seems that the result to the patient exceeds considerably from the expected result of normal proceedings in a similar case;
• An event in which it is apparently clear that procedures or clinical guidelines were violated, even if no real harm was caused to the patient due to same.

From the report of the Public Claims Commissioner in regards to a Summary of 100 investigation committees reports – drawing conclusions from exceptional events dated June 2016 it is derived that in every case the discretion of the competent body to decide whether to appoint a committee in cases which do not fall under the qualifying criteria, or not to appoint a committee in cases that do fall under the qualifying criteria (as long as the competent body took care to investigate the case in another way) was reserved.[48] We should note, that in this regard the question is raised on what scope of cases we are dealing with and what are the reasons and considerations for that.

As stated in the Ministry of Health’s website, in cases where the Commissioner decides on appointment of an investigation committee, a notification about it is conveyed to the investigated bodies.[49]

Within the framework of its activity the investigation committee locates experts in the relevant field, summons witnesses [the patient, his / her family members etc.] and medical team members, and informs the involved parties of the right for legal representation for them. The minutes of the discussions in the investigating committee are written down or recorded in a protocol [although partial confidentiality applies on them according to clause 21 of the above mentioned Patient Rights Law]. After examining the topic at hand the investigation committee issues a report with recommendation whether it has reached the conclusion of a medical negligence case which justifies submission of a disciplinary complaint.[50] The Commissioner for Public Complaints attaches his recommendation to this report and passes the matter at hand to the ruling of the Director General of the Ministry of Health.[51]

2.3. The Disciplinary Court Unit of the Ministry of Health

In case the Director General of the Ministry of Health decides on submission of a complaint in regards to said issue, the file will be transferred to the prosecutor of the Ministry of Health and deliberated in the Disciplinary Court Unit of the Ministry of Health, which constitutes part of the legal office of the Ministry and handles disciplinary proceedings against all the medical and paramedical professions pursuant to the applicable legislation of each profession.[52] The disciplinary violations affixed in the applicable legislation are: Severe negligence, behavior not becoming the profession, indictment in a criminal offense, obtaining a license by misrepresentation, ongoing violations of legislation and violation of the Patient Rights Law ruling.[53]

As stated in the Ministry of Health’s website, The disciplinary committee to discuss a specific complaint is set by the Minister of Health and comprises of two professionals and a lawyer. We should note, that in State Comptroller's report 62 stated earlier, it was written that the disciplinary committee comprises of representatives  from the Ministry of Health, the Ministry of Justice, the Medical Association of Israel and lawyers from the legal chamber in the Ministry of Health.[54]

The role of the disciplinary committee is to hear the arguments of the parties, to examine the material of evidence and prepare a factual and normative infrastructure,[55] and she submits its recommendations in regards to following disciplinary means: warning, reprimand, suspension or revoking of a license.[56]

The deliberations in front of the disciplinary committee are public proceedings, unless it had been decided on closed doors due to security or morals reasons.[57] During the deliberations, in which framework the party the complaint has been submitted against is eligible to be represented by an attorney speaking on his / her behalf, the members of the disciplinary committee hear the parties’ arguments, examine the material evidence and pass their recommendations to the ruling by a judge, to whom the authority of the Minister of Health had been delegated, to make a decision on the complaint pursuant to clause 41 of the Physicians Ordinance [old version] 5731 – 1976. The judge is authorized to acquit the physician, to give him a punishment of reprimand, to warn him, to suspend his license for a period up to five years or to revoke his license altogether. The recommendations of the disciplinary committee are conveyed to the Minister of Health, and he has the authority to adopt or reject them.

It is possible to appeal the judge's ruling in the District Court within three months of the day the notification about the ruling was received.[58]

2.4. The state comptroller comments about the status of the Public Complaints Commissioner for the Medical Professions

In report 62 mentioned above the State Comptroller discusses, inter alia, the status of the Public Claims Commissioner for the Medical Professions. The State Comptroller indicates that in the inquiry it conducted it was found that various parts of the commissioner's activity are indeed legally regulated, in various internal instructions and procedures. However, according to the State Comptroller these sources are not regulating the complete scope of its activity and they lack legal definition concerning the authorities and obligations of the Complaints Commissioner as well as of the investigation committees appointed by him.[59]

The State Comptroller is of an opinion that the Ministry of Health has to consider defining the Complaints Commissioner authorities to summon witnesses or experts; to arrange an assigned budget for the activity of the Complaints Commissioner; and to enable a possibility to appeal the Commissioner's decision in regards to the setup of an investigation committee or in regards to the submission of a complaint. In addition, the State Comptroller suggested that the Ministry of Health and the Ministry of Justice will examine whether there is room to transfer the entire activity of the Complaints Commissioner to the Ministry of Justice, the investigation committees as well as the disciplinary deliberation or alternately the activity of the Complaints Commissioner and the investigation committees only. In addition, it was proposed, inter alia, to examine the argument that a physician must head of the inquiry system (that is, in the role of the Public Complaints Commissioner for the Medical Professions) and consider to appoint for the position of the investigation committees members retired medical consultants who are not committed any more to any one medical institution or another.[60] We should note, that in the report Prime Minister's comments to State Comptroller report 62 – Part 1 made public in May 2012, the Ministry of Health advised that "draft proposal for regulating the status of the Commissioner will be submitted to the Director General [Ministry of Health] until the 30^th of April 2012" [the bold face not in the original][61]

In response to the Knesset Research and Information Center as to how The Ministry of Health acted in light of the recommendations of the State Comptroller stated above, the Ministry of Health answered that the legislation memorandum in regards to regulating the independence, authorities and modus operandi of the Public Claims Commissioner is at advanced stages. According to the Office, the memorandum has already been introduced in the former tenures of the government, however not promoted until the present.[62]

 We should note, that in the discussion of the State Audit Committee of the Knesset on 16 / March / 2017 on the topic of "Request for an opinion of the State Comptroller on the subject: concealment and cover-up of negligent medical cases while harming the patients’ population – follow-up session", the Public Complaints Commissioner for the Medical Professions, Dr. Boaz Lev mentioned that in light of the issues raised in the deliberations it is possible that the Ministry of Health will make a change in the legislative memorandum of the said law.[63] Until the submission of this document, some three months after the time of the stated deliberation, the legislative memorandum was not made public yet.

3. The Ministry of Health data on deaths and events which must be reported and on claims investigations due to medical negligence

In this chapter we wanted to examine the number of reports on exceptional events and on exceptional deaths delivered to the Ministry of Health, vs. the number of claims where a suspicion was raised for medical negligence which were passed to be handles by the Public Claims Commissioner for the Medical Professions and the number of the disciplinary decisions made by the Disciplinary Court Unit of the Ministry of Health handling medical negligence.

According to the Medical Administration circular number 11/2012 in regards to obligatory notification of a medical institute on deaths and exceptional events dated 9 / May / 2012 the must be reported events to the Ministry of Health are as follows:

• Severe and irreversible damage caused to the patient during a medical treatment or afterwards, including death, which apparently cannot be ascribed to the natural / expected process of the patient’s disease;
• Accidental leaving a foreign body behind during surgery or invasive action; an error in surgery including of the wrong organ or limb or of wrong patient;
• Causing a second or a third degree burn during surgery or an invasive action;
• Error in giving of red blood cells, mistaken identification of the patient or a mistake made in ABO blood typing;
• Error in administration of a medication which caused the patient a significant harm including death;
• A suicide attempt of a patient done while being hospitalized or on leave from the hospitalization and ended with a severe and irreversible damage or death;
• The death of a woman during pregnancy or childbirth or within 42 days from date of childbirth and her death within one year after birth if the cause of death is associated with the pregnancy or the childbirth;
• Death of a newborn (who has not been discharged from the hospital) who was born after the beginning of week 32 of the pregnancy, which is not a result of a congenital birth defect;
• An occurrence for which the Director of the medical institutions decided to appoint an investigation committee as intended in clause 21 of the Patient Rights Law 5756 – 1996;
• Cases in which a reoccurring damage to the patient is identified as a result from use of medical technology (surgery method, surgery approach, medical device etc.)[64]

Additional events which must be reported as per stated circular are: severe damage caused to the patient or the employee of the medical institute as a result of a failure of a medical device during medical treatment; severe and irreversible damage caused to the patient in a medical institution's area as a result of a building or infrastructure belonging to the institution; failure or disruption in the operation of an essential service for the proper functioning of a medical institution or part thereof (including electricity, water and medical derivatives); an internal or external emergency situation at the medical institute which influences or may influence its functioning.[65]

The circular determines that a notification on an exceptional event will be delivered in writing to the Medical Administration Director, his deputy or any person appointed by him for taking care of the topic, within 24 hours from the moment the event occurrence was known (if happened on a holiday or on the sabbath – the notification will be delivered within 48 hours). An exceptional event which ended up in death /  brain death will be reported by telephone as well as soon as possible (and no later than 24 hours from the occurrence of the event) to the Medical Administration Director or his deputy.[66]

In addition, the circular specified deaths which must be reported to the Ministry of Health as follows: deaths occurred with 24 hours from admitting a patient for hospitalization or to an Emergency Department, except for death as a result of terminal stage of a chronic, degenerative or other disease; a person who was brought dead to the hospital, except for death as a result of external cause; death during the course of surgery or other invasive procedure or within seven days from the day these were conducted, including cases in which the patient has been discharged for his home ( if he had returned to the hospital or if the death was brought to the attention of the physician in the community); death following surgery or another invasive procedure if the patient did not recover from them prior to his death; death as a result of a suicide attempt performed outside of the medical institution, death of a person less than 30 years old, who did not suffer from a chronic or terminal disease.[67]

According to stated circular, notification about death which must be reported will be delivered to the evaluation department in the quality control division within 14 days from date of death.[68] The report will be conveyed in writing, and the following documents will be attached to it: Summary of death, in case of a patient who was treated in a number of wards during the last hospitalization and the summary of death does not reflect the treatment process in them- all the transfer summaries from the various wards should be attached as well; in case of death in the emergency ward, the referring letter from the family physician and / or the document from Magen David Adom as much as these exist.[69]

3.1. Deaths and Exceptional Events in which Reporting is Mandatory

The Following introduces the data of the Ministry of Health received in response to our inquiry on the number of deaths and exceptional events reports received in the Office between the years 2005 – 2016 in accordance with the circular. In some of the years, the table depicts also the Ministry of Health data on not mandatory to be reported events according to stated circular.

Table no.4; Ministry of Health data on the number of reports on deaths and exceptional events mandatory to be reported 2005-2016[70]

It transpires from the table that in the years 2005 – 2016 some 3,646 reports were received at the Ministry of Health on events which are mandatory to be reported as per the above stated circular and 56,122 reports on exceptional deaths as defined in the circular. The data of the Ministry of Health brought in the table demonstrate that in the years 2005 – 2016 a constant increase of more than 2.5 times occurred in the number of reports in regards to exceptional events obligating reports received by the Ministry of Health, from 190 reports in 2005 to 511 reports in 2016. In the Ministry of Health the attributed this increase to the following causes:

• A direct reporting computerized system was setup in 2005, allowing for direct reporting on exceptional events and special deaths and which according to the Ministry of Health makes it easier for the medical institutions to report and thus increases the number of reports. In the Ministry of health it is noted that the information system is active since 2015 and most the general hospitals and the Community Directorate of the Clalit Medical Services are connected to it. In the Ministry of Health it was noted that they are in the process of implementing the computerized system in additional medical institutions, such as psychiatric and geriatric hospitals as well as in the community, however we have no information about the expected date when the entire relevant medical institution will be connected to the stated system. With regards to institutions which are not yet connected to the computerized system, it was noted in the Ministry of Health that their reporting is submitted via a structured reporting form designated for events and special deaths reporting and is sent to the Ministry of Health mainly be electronic mail.[71]
• The setup of the Treatment Safety Array in the Ministry of Health in 2011, which purpose is engagement in promoting the topic of treatment safety and reducing the number of the safety events through the creation of a safety culture in the medical institutions (the entirety of the hospitals and clinics in the community).[72] According to the Ministry of Health, this array is acting to increase the medical institutions’ awareness to the topic of treatment safety and encouraging reporting of exceptional events thorough, inter alia, the setup of forums for risk managers to engage in knowledge sharing, distribution of safety treatment circulars describing exceptional events, improvement of work processes following reports on exceptional events and training in the field of treatment safety in the medical institutions.
• Encouragement of medical institutions by the Treatment Safety Array to report also on events which are not obligated to be reported about according to the above mentioned circular and on "almost events". It can be seen in the above table that a significant increase has occurred in the number of these reports from 10 reports in 2014 to 159 reports in 2016.[73]

As for reports on special deaths cases it can be seen that while the number of reports in the years 2005 – 2014 has increased between 4,731 reports in 2009 to 5,579 reports in 2011, a certain decrease in the number of reports about deaths in the years 2013 – 2016 can be seen, and the number of reports number moves from 4,465 reports in 2013, to 3,055 reports in 2014. This decrease in the number of reports on special deaths is attributed in the Ministry of Health to the fact that the implementation of the computerized system on deaths has compelled the medical institutions to report only deaths meeting the reporting criteria and therefore the Office receives only reports meeting the criteria defined in the circular and not on every death occurring in a medical institution.[74]

A question is asked on what is the scope of the special deaths of all the deaths in Israel in general, and in the hospitals in particular. From the CBS data it transpires that in 2014 there were 42,170 deaths, out of which about two thirds of them (27,919 deaths) were in hospitals. Given that in 2014 were 3,055 special deaths cases, than the discussed number of deaths was 11% in the hospitals in that year and approx. 7% of all deaths in Israel in that year.[75]

In addition, a question is asked to what extent the data on the number of special deaths and number of deaths correspond to the scope of actual events. The Ministry of Health advised the Knesset Research and Information Center that it is following the execution of the procedures detailed in the Office's circular in regards to the obligation of a medical institution to report o deaths and exceptional events and as specified in the circular: “This procedure is binding for all the medical institutions and they must therefore report on exceptional events and deaths according to the criteria mentioned in the circular. Over the years we can see an increase in the reporting however we assume that under reporting exists (the problem is known worldwide and is not unique to Israel). We have no way to check whether the hospitals are reporting on all the events meeting the criteria[76] [the bold face highlight is not in the original]. In addition, it was stated in the Ministry of Health that they estimate the more severe is the damage caused so the number of the reports is higher and the number of the reporting decreases when the damage caused is less severe.[77] The meaning of which is that the Ministry of Health is also of the opinion that the data it holds does not reflect the actual situation. According to the Ministry of Health, in severe cases where no reporting was submitted as is obligatory, the Ministry of Health is taking sanctions against the institutions according to the circumstances,[78] however, it did not mention what are the sanctions.

According to the Ministry of Health it acts to create an organizational culture which encourages reporting which purpose is systemic learning, in a number of ways, among them are: encouraging the medical institutions to report on events where no obligatory reporting is required, as well as reporting on "almost events" in addition to the creation of close work relations and trust between the departments and the safety units in the medical institutions.[79] The Ministry added that the work of the Treatment Safety Division is performed in confidentiality by the Quality and Control Committee [according to clause 22 of the Patient Rights Law detailed above] in order to lessen the concern derived from conveying the report to the Ministry of Health or conveying the information and organizational learning from exceptional events to external bodies (such as lawyers etc.)

3.2. The Ministry of Health data on the number of investigation committees established to examine suspicion cases of medical negligence

As stated, in cases a decision is made by the Medical Administration in the Ministry of Health that there is a need of an in-depth inquiry of the occurrence, the case details are conveyed from the Medical Administration to the Public Complaints Commissioner for the Medical Professions at the Ministry of Health. The Ministry of Health has submitted to us data on the number of complaints referred to the Commissioner by various bodies where suspicion of medical negligence had been raised as well as the number of investigation committees established in order to examine these cases in the years 2008 – 2016.

Table no. 5: the number of complaints in cases where a suspicion of medical negligence was raised and the number of investigation committees established 2008 – 2016[80]

It transpires from the table that in the years 2008 – 2016 (not including year 2013) more than 1,000 complaints per year were submitted to the Public Commissioner for the Medical Professions on cases in which a suspicion of medical negligence was raised, which add up to a total of 9,369 complaints. We would like to note that in the years 2008 – 2016 some 3,007 reports were submitted to the Medical Administration on events obligating reporting and 40,509 reports on special deaths.

Although in these years some 9,369 complaints were submitted on cases in which suspicion was raised of medical negligence, 320 (3.4%) investigation committees were established, meaning only for 2.04% and up to 4.4% of all complaints submitted in one year for which an investigation committee had been established. We should note, similarly to the findings of the State Comptroller, depicted in report 62 it seems ,inter alia, that indeed in only small part of the complaints cases the Commissioner had decided on appointment of an investigation committee in their matter, since between January 2009 and until the middle of 2011 some 2,790 complaints were submitted to the Public Complaints Commissioner, on which basis he appointed 89 investigation committees (3.1%).[81]

The Ministry of Health and the Public Complaints Commissioner wrote to the State Comptroller in 2011 that the investigation committees provide response to most of the exceptional events reported by the medical institutions, when in cases where a complaint is filed to the police, the Commissioner is precluded from investigating. It has been further mentioned that "The majority of the submitted claims do not justify setting up an investigation committee and these also include complaints about faulty personal relation and on setting appointments. After clarifying the circumstances of the case with the complaining party, the Commissioner decides that the circumstances do not justify further handling; in part of the complaints the Commissioner is authorized to give a remark or general warning with necessitating disciplinary procedures; In an additional part of the complaints the Commissioner consults with the Ministry's medical experts, and in other part consults with medical experts outside of the Ministry, and decides in regards to the handling of the complaint; Only in a small part of the cases, usually the difficult ones, the Commissioner decides to establish an investigation committee.[82] The State Comptroller noted that private lawyers, specializing in the field of medical negligence advised the State Comptroller that in large part of the medical negligence cases civil claims are submitted directly to the Courts without a complaint to the Public Claims Commissioner in the Ministry of Health "this is due to the recommendation of lawyers to their clients not to submit a complaint to the Claims Commissioner, resulting from their concern of non – exhaustion of the disciplinary procedures against the subjected physicians and due to the prolongation of the procedures".[83]

According to the Ministry of Health, the average time duration for the handling of public complaints arriving to the Public Complaints Commissioner for the Medical professions stands at 117 days ( about four months) where the median stands on 84 days ( about two and half months). In 2015, the duration of handling complaints for which it has been decided on clarification through investigation committees took 10 months until their closure.[84]

3.3. Disciplinary Court Unit of the Ministry of Health data

We have no information in how many cases of the 320 investigation committees se forth in the years 2008 – 2016 to examine the complaints about the cases where suspicion was raised of a medical negligence in which it had been decided on transferring the complaint to the Disciplinary Court Unit in the Ministry of Health. According to the State Comptroller report of January 2009 and until middle 2011 the Public Complaints Commissioner had appointed 89 investigation committees following which 64 complaints were submitted to the Disciplinary Court of the Ministry of Health (72%).[85]

The Ministry of Health has presented  us with data on the number of meaningful decisions made in the years 2012 – 2016 and the number of decisions in regards to medical negligence of them. In the specified years some 155 disciplinary decisions were made, where about one fifth out of which (32 decisions) were about negligence files. We should note, that in the stated years (2012 – 2016) 163 investigation committees were set up in order to examine complaints in cases where suspicion of medical negligence were raised.

Table no. 6: The ministry of Health data on meaningful decisions of the Disciplinary Court in the Ministry of Health in regards to medical Negligence, segmented according to the decision made in 2012 – 2016[86]

From the above table it transpires that in the years 2012-2016 out of 32 decisions in negligence files, in 6 cases acquittal was awarded and in 26 cases a penalty was imposed.

Chart no.1: Segmentation of punishment decisions of the Disciplinary Court Unit in cases of medical negligence 2012-2016[87]

In none of the decisions the license of the physician was not revoked. We should note, that we hold no data in regards to the duration of handling of the above stated cases by the Disciplinary Court Unit of the Ministry of Health and on the duration of the suspension of licenses. In addition, we have no information on the number of decisions in which an appeal was submitted on the decision of the Disciplinary Court to the regional Court.

4. The Economic Burden due to Medical Negligence Claims Against the Governmental Medical Institutions

As stated, in the Ministry of Health note that in the recent years a substantial and constant increase occurred in the scope of the financial demands and the claims against the State submitted to the Courts and the insurers due to medical negligence in Israel. According to the Ministry, the increase does not necessarily emanate from increase in the number of medical harms due to medical negligence but among other things results from an increase in the public awareness of medical negligence and by practicing their rights to submit claims, and as well as due to the fact that over the years the Courts ruling broadened their responsibility for torts incurred by medical professionals and the medical institutions. In addition, the ruling increased the compensations awarded to benefit the winning parties and has made more difficult the actuary assessment and the retaining of funds for the long range as required. Therefore, it is noted in the Ministry of Health, that a substantial increase occurred in the national spending for healthcare due to the expenses of the medical institutions on claims due to medical negligence.[88]

In the absence of data in regards the scope of medical negligence cases in non – government owned institutions, it is therefore not clear what are the total expenses of these institutions due to medical negligence. As for governmental institutions, the body providing insurance cover to these medical institutions for medical negligence is the internal trust for government insurance operated by "Inbal" Insurance Company. The coverage includes professional responsibility of the Ministry of Health as the operator of medical institutions and as the provider of medical services.[89] In response to a query made by the Knesset Research and Information Center whether the various medical institutions are obliged today to insure themselves against medical negligence in the Ministry of Health they replied that at the present there is no mandatory insurance for medical institutions, neither within the framework of legislation nor in the Ministry of Health procedures, however all the medical institutions in Israel have insurance arrangements due for medical negligence.[90] The Israel Medical Association (herein after IMA) explained that through the power of collective bargaining Between IMA and various employers (such as the State, Clalit health services, Leumit health maintenance organization, Hadassah and shaarey zedek hospitals) the employers have the obligation to insure the physicians.[91]

As stated, between the years 2005 – 2015 some 8,372 claims were submitted against governmental medical institutions due to medical negligence – it is unknown to us what is the rate of claims that were closed out of above and how much compensations were awarded for these claims. The Ministry of Finance has passed us data on the total payments made by the insurance companies providing coverage for medical negligence by the governmental medical institutions only, data taken from the database of Inbal insurance company for the years 2005 – 2015[92]. We shall present the data on the actual total payments made in thousands of NIS in claims due to medical negligence for the years 2005 – 2015 segmented by the type of the insured party. We should note , that not all the claims in which payment was made to the claimant are claims where ruling was received, when according to the Ministry of Finance, in most cases these amounts were paid within a framework of settlement agreements following the claims submitted in the Courts.[93]

Table no. 7: Ministry of Health and Ministry of Finance data on the actual total payments made (in thousands NIS) on claims due to medical negligence in governmental medical institutions in the years 2005 – 2015 according to type of the insured party[94]

As can be seen, in the years 2005 – 2015 some 2.32 billion NIS were paid in compensations for medical negligence in the governmental medical institutions. By segmenting the data according to type of insured party it transpires that most of the stated amount were paid due to claims against general hospitals (approx.  82% of total payments); approx. 15.8% of the amount was paid due to claims against the Ministry of Health clinics; approx. 1.8% of the amount was paid due to claims against the mental health hospitals; approx. 0.9% of the amount was paid due to claims against the Ministry of Health and approx. 0.09% of the amount was paid due to claims against geriatric hospitals. It further transpires from the data presented in the above table that in general, an increase of almost doubling the paid amounts occurred in the total payments for claims due to medical negligence in the years 2005 – 2015 from about 138 million NIS in 2005 to about 262 million in 2015. As stated, in those years the number of claims increased from 597 claims in 2005 to 1,008 claims in 2015.

We have also requested from the Ministry of Finance data about the average and the median payment per claim paid for medical negligence against governmental health institutions in every one of the years 2005 – 2015 which are as follows:

Chart no. 2. The data from the Ministry of Finance (in thousands NIS) about the average and median payment per claim paid for negligence against governmental medical institutions for claims received , 2005 – 2015 [95]

The following transpires from the above chart: the highest average compensation per claim paid was in 2006 in the amount of NIS 505,000 whereas the lowest average compensation was in 2015 and was in the amount of NIS 416,000 per claim. In regards to the median payment, from above chart it transpires that the highest median compensation per claim was in 2011 in the amount of NIS 203,000 whereas the lowest median payment was in 2011 in the amount of NIS 111,000.

4.1. The Reasons for the Increase in the Number of Claims and their Consequences

The Ministry of Finance advised the Knesset Research and Information Center that the data depicted above point to an increase in the number of claims submitted against governmental institutions for medical negligence and as result also to the increase of the amount paid to cover these claims.[96] The State Comptroller has also noted that "Following the changes and increased rigorousness in the Courts rulings, the increase in the compensations awarded to those that were harmed and the increase in the scope of the submitted claims in cases of medical negligence, the national expense spent on medical negligence claims has increased for the entire health system."[97]

IMA has advised in this subject that they are witnessing new populations joining the claimants circle in the recent years, multiplicity of class actions suits in the area of insurance and as well as a situation in which many claims are submitted in delay and continue for many years.[98] In addition, the creation and development of harming the autonomy of the patient as a cause of claim, brings about more opportunities to submit claim, as well as the modern medical advancement and the multiplicity of checks for early discovery and the early prevention of sickness.[99] On the other hand, according to the Israel Bar Association as quoted in the State Comptroller’s report 62, in the calculation of the increase in costs emanating from medical negligence we should also take into the account the growth of the population in Israel, as well as the development of the laws of torts and partial breaking of the "conspiracy of silence" of the physicians which brought about the development of claims submission in this field, similar to the development in other legal fields.[100]

A question is therefore raised, whether there are medical fields in which a higher number of medical negligence can be seen in comparison with other areas of medicine. According the Ministry of Health, the medical fields leading in payments for claims for medical negligence are: maternity (including emergency maternity); emergency department (internal emergency, orthopedic emergency, surgical emergency, and children emergency; neurosurgery; general surgery; internal medicine; orthopedic; health clinics (pregnancy follow-up).[101] We should note that the Knesset Research and Information Center does not hold data about the share of each of the fields mentioned above out of the total payments made for medical negligence or if the order of the fields depicted above shows these fields according to particular order or this is merely a general list.

In regards to the stated question the IMA noted that the medical professions in which there is a higher risk for a physician to be subjected to a medical negligence claim are obstetrics and gynecology as well as medical genetics. According to the IMA, these professions largely handle medical cases concerning pre-birth and birth events, in which a significant increase occurred in recent years in claims made on behalf of newborns who were harmed during birth and in the compensations amounts awarded in cases where it had been determined that medical negligence occurred. According to the IMA, the fact that these professions are in heightened risk for claims causes physicians to distance themselves from these professions or occupation in the specific sub-fields which are not directly concerned to the study within those fields.[102] In addition, this increases the use of defensive medicine in these fields. We should note, that in response to our application to the Israel Bar Association whether it is possible to identify certain medical fields in which there is inclination for many more claims for medical negligence the Bar Association responded that they are unable to indicate on certain fields , since these are diverse claims.[103]

5. The compensation model for damages caused as a result of medical treatment customary in Denmark

The Global Legal Research Center of the Law Library of the U.S. Congress (The Law Library of Congress)[104] has performed a survey of the accepted arrangements in regards to the bearing of responsibility in cases of medical negligence in Canada, England, Wales, Germany and India (countries with a publicly financed medical system) from which it seems that the claims submitted in regards to medical damage are usually damage claims against the treating party due to neglect or negligence or claims against a medical institution. According to the Law of Torts approach customary in these countries, as well as in Israel, in order for a compensation to be awarded to a patient claiming that he was harmed during a medical procedure he has to prove that the party that treated him bears the responsibility to the damage caused to him.[105]

An alternate model to the Law of Torts is the "no fault" model customary, inter alia, in the Scandinavian countries.[106] While in the approach of the Law of Torts the patient has to prove that the treating party is guilty or bears the responsibility to the damage caused to him, according to the "no fault" approach, the awarding of compensation does not depend on the proof of guilt or negligence of the treating party, but of adequate proof of causal connection between the medical treatment that the patient had undergone and the damage from which he suffers.[107]

IMA has noted to us that already in the 18^th Knesset an attempt was made to promote the mechanism of the "no fault" in Israel, which the IMA is of the opinion that it will assist with the distancing of physicians from certain professions and with the use of defensive medicine because of the concern from medical negligence claims. A law proposal of compensation to the damaged at birth 5770 – 2010 of Knesset members Meir Shitrit, Zeev Elkin, Avraham Michaeli, Haim Katz and other Knesset members, has passed in preliminary reading and its essence was: compensating newborns suffering from birth defect even if no medical negligence occurred; limiting the compensation awarded due to damages to children; appointment of a medical committee for compensation to those damaged at birth which will determine the eligibility of the applicant and, inter alia, the level of compensation; the establishment of a trust fund to cover those damaged at birth; the uniqueness of cause – any person who has a cause for claim according to this law will be able to submit a claim only according this law and will not be able to submit a claim under any other law.[108] IMA noted that the legislation process did not advance due to early elections and that IMA is acting these days to promote the law proposal vis a vis the relevant Government Ministries, since, according to them, it is an obvious and essential step in this field.[109]

We shall introduce the principles of  the “no –fault" model, customary, inter alia, in Denmark in this chapter. We have chosen to focus on this country since we could find ample on-line information on this subject in Denmark, as well as due to the fact that this country is often depicted in publications on the topic of medical negligence as representing this model.

5.1. The Legal Framework which Regularizes the Compensation Model in Denmark

Until 1992, any patients patient who were interested in submitting a claim for compensation due to damage caused to them within the framework of medical treatment in the health system in Denmark, which is largely publicly financed,[110] had to prove in legal litigation that the damage they have sustained was caused by an error of a health care professional. As it transpires from the professional literature, due to the difficulty associated with proving the occurrence of an error by a health care professional and in order to make it easier on patients that were harmed to receive compensation, it was decided in Denmark on the set up of a public compensation model according which there is no need to prove the occurrence of an error, but in order to receive compensation the existence of a connection between the injury that may have occurred in connection with the medical treatment, examination or due to medication is sufficient.[111] In addition, within this model’s framework, the patient is not required submit his claim to the Court or to be represented by a lawyer.[112]

The stated model had been anchored in the Danish Patient Compensation Act, which came into effect in 1992 and as the legislation was broadened in regards to compensating patients in Denmark over the years, so as of 2004 it relates to almost all the areas of activity of both, the public health and private health systems, including: private and public hospitals, ambulance services, injuries by donors or participants in medical trials according to the established rules, general practitioners and expert physicians, chiropractors, occupational therapists, physiotherapists and Podiatrists (feet physicians), nurses, midwives, clinical dietitians, medical laboratory technicians and other professionals in the medical field. At the present, the stated laws in regards to compensation to patients are collected into the framework of the the Danish Act on the Right to Complain and Receive Compensation within the Health System.[113]

5.1.1 The Danish Patients Association for Compensation (Patientterstatningen )

In order to implement this compensation model Patients Association for Compensation the Danish Patients Association for Compensation – Patienterstatningen was established in 1992 (hereinafter: the Association).[114] According to the Association’s website, it is an independent body, managed by a council of seven members: one of the council members is appointed by the Minister of Health and Prevention and the rest are appointed by the regions authorities. The role of the committee members is to ensure that the work of the Association is performed properly, whereas the daily running of the Association is conducted by the Administrative Department employees,[115] which according to the website of this body their number stands on about 200 people.[116]

The Association is the main body of the patients who were injured during medical treatment compensation system, which purpose is to ensure the awarding of compensation to the injured. This body’s framework, does not include examination of the professional conduct of one certain medical party or another, but with the assessment of the injury itself and the eligibility for compensation due to same.[117] The objectives of the Association, as published in 2008 are, inter alia: professional and efficient management of claims’ compensation; service to the patients and medical personnel; and a promise that injuries recorded in the Association system will be used to prevent future injuries.[118] The vision of the Association, as it appears in the website of this body includes: being the leading expert in Demark for compensation to patients due to injury; to work in cooperation with experts in the medical field; to shorten the length of time of handling applications in the best possible way through improved streamlining of the applications handling process, management and digitations; striving to ensure that both, patients and health care professional will report on the total injuries occurrence for which compensation can be received; to be an active partner in the fields of compensation and injury prevention.[119]

According to the stated in the the Danish Association for Compensation to Patients website it can be learned that the types of injuries for which occurrences during a medical treatment it is possible to submit claims for compensation are: injuries sustained due to medical treatment, medical examination or lack of treatment;[120] injuries caused due to severe adverse effects of medicines approved for marketing in Denmark and given to the patient in a pharmacy, by a physician, a hospital or a dentist or were bought in an authorized store for selling medicines without a prescription.[121] In addition the Danish legislation refers to the rights for compensation for those participating in clinical trials and blood and organ donors and details the terms and conditions to receive them.[122] The Association will compensate the patient if the occurred injury meets one of the following conditions: If an experienced medical expert would have been acting in same situation in a different manner (" The specialist rule"); if the existing complications are very exceptional and severe in relation to the treatment given to the patient due to the disease he is suffering from, and exceed what a person could bear ("the fairness test"); if there was a failure in the medical device; if the injury could have been prevented by using a different method, technique or any other equal treatment.[123]

It should be noted that, within the framework of the Association it is not possible to claim compensations due to mental injury on the background of medicines use. As well as it is not possible to receive compensation due to the suffering and sorrow caused by the loss of a family member due to injury during medical treatment.[124]

In addition, the stated compensation system does not include treatments received by the patients out of Denmark borders without a referral of the attending physician (such as of private initiative); treatments conducted in Greenland; treatments conducted in the Faroe Islands prior to 2012 and in some other cases.[125] We should note, that it is indicated in the Association’s website that in regards to injuries cases which background is not included in the stated legislation, there is a possibility for the injured person to claim compensation according to the general Law of Tort.[126]

As of 1^st January 2008 injuries become obsolete (statute-barred) three years after the patient became aware that he has been injured.[127] From an information leaflet of the Association about the possibility to receive compensation due to injury during a medical treatment it transpires that the patient has to submit his claim for compensation within three years from the moment that he discovered about its occurrence and within ten years from the day it occurred. Compensation on injury within the framework of a medical treatment will be awarded only for injuries where the compensation for same is more than 10,000 Danish Krone[128] (approx. NIS 5,300) whereas compensation on injury for medication treatment add to a total of 3,000 Krone (NIS 1,620).[129] The reason for which, according to the researchers, is in order to focus on compensating the more serious injury cases.[130] We should note that the compensation amounts (excluding for the interest accumulated for the compensation amounts) are not subject to taxation, except for compensation due to loss of income.[131]

5.1.2 The Manner Claims are submitted to the Danish Patient Compensation Association

Patients interested in receiving compensation for events happening to them during a medical treatment have to fill a claim form and submit it to the Association either by fax or online by e-mail.[132] We should note, in this context, that the information leaflet of the Association indicates in regards to receiving compensation due to injury sustained during a medical treatment it seems that the medical professionals are obliged to inform the patient about the existence of the Association in case they are of the opinion that the patient was injured in a manner that might make him eligible to receive compensation as well as assist the patient in submitting his claim if it is necessary.[133]

We have no data about the budget of the Association. Nonetheless, as it seems from the information on the Association’s website, the activity of the Association is publicly funded, and therefore those appealing to it are not required to any expenses in connection to the submission of a claim. In addition, any person who receives a treatment either in the private or public health system in Denmark is eligible to receive compensation,[134] and they are not required to represent their claim by lawyer.[135]

With the receipt of the claim from the applicant, the Association is examining it in order to ensure that it holds all the required information and following this sends the claim for the response of the party or place where the injury was sustained (hospital, physician and the like). Following that the stated party has to fill a report about the event and to send to the Association the medical record (journal material).[136] The receipt of the stated material in the Association takes between one or two months and then a copy of the report received by the Association is sent to the claimant and he is given the possibility to submit his comments. With the completion of this process the handling of the case is transferred to the lawyers of the Association who examine if indeed an injury occurred and whether the conditions for compensations to be awarded were filled. The case will be discussed, usually within the framework of "physician meeting" (doctor meeting) where the lawyers and the physicians who are handling the case discuss the claim case details. At times the physician may ask for additional documents for examining the case, such as a physician statement etc.[137] We should note, as can be deduced from the Association’s website, the Danish physicians who discuss claims are banned from handling cases which occurred in the place of their current employment or where they were employed when the occurrences occurred. If it becomes clear that this rule was not adhered to, the case will be reopened and discussed anew.[138]

According to the stated in the Association’s website, the average handling duration of the claims is approx.  seven months from the moment the claim has been received until a decision is made on in its regard. In case it was decided that the claimant is eligible for compensation, the calculation of the level of the compensation is performed in accordance with the Danish Law in regards to the responsibility for compensation (The Danish Liability for Damages Act).[139] In general, it is possible to receive compensation in the following cases: expenses for health and other loss; loss of income, pain and suffering; permanent injury; work disability and more.[140]

In cases where injury occurred in the context of a treatment provided by the national health services of Denmark, The compensation are paid by the regions and by the insurance companies in which the private health providers are insured. In cases of injury following use of a medication, the party responsible for the payment of compensations is the Ministry of Health. Compensations due to treatment in private frameworks outside of the national health services are funded through the insurance companies in which the health service providers are insured. Compensations due to injuries caused in the context of a treatment given to prisoners incarcerated in jail houses are funded by the Danish Prison and Probation Service, and compensations due to injuries caused in military clinics are funded by the Danish Ministry of Defense.[141]

In case the claimant is not satisfied with the decision of the Association in his case, he has the option to appeal to the Appeals Compensations Council (the Patient Compensation Appeals Board) which has the power to increase the awarded compensations amount, to reduce it, or even to cancel it altogether.[142] This council is appointed by the Minister of Health. The Chairperson of the Council and his deputies who are appointed by the Ministry of the Interior and the Ministry of Health are judges, and the other members of the council are appointed by various parties among them: the National Council for Health, the Danish Insurance Association, the Danish Bar Association, the Consumers Council and other bodies.[143]

5.1.3 Data on Claims Discussed by the Danish Association for Patients Compensation

The database of the Association is published within the framework of a research on the subject of Existing data sources for clinical epidemiology: The Danish Patient Compensation Association database of a group of researchers in the year 2015 demonstrates that between the years 1996 – 2013 an increase occurred in the scope of claims submitted to the Association from about 2,000 claims in the year 1996 to some 10,000 claims in the year 2013 (the population of Denmark numbers about 5.7 million residents).[144] In regards to the number of claims in which compensation was awarded, it can be learned from the stated article that out of 9,628 claims for compensations submitted to the Association in 2012, 33.1% claims were authorized. The level of compensation awarded due to the authorized claims was at about 144 million U.S. dollars.[145]

It can be learned from the above stated article about the distribution of the authorized claims in that year by the Association according to causes: 

Chart no.3: The Distribution of Claims Authorized by the Danish Patient Compensation Association by Causes, 2012[146]

As stated, the database of the Association includes information about the scope of the claims only, and therefore it cannot be deducted from these data on the total number of injury cases of patient occurring in Denmark within the framework of medical treatment.

It is important to note that we do not hold information how is this model actually implemented, and with this mission information for example its position and role within the fabric of the bodies responsible for handling patients claims and drawing conclusions, on the extent that this arrangement eases the claims submission process due to injury during a medical treatment and to what extent it makes the response to the patients population more accessible, as well as the level in which this body succeeds to constitute a suitable response for those applying to it.

[1] Gaby Bin-Noon, Yitzhak Berlovitz, Mordechai Shani, 2010 The Medical System in Israel, Ms. Bin-Noon, Yitzhak Berlovitz, Mordechai Shani, 2010.

[2] The BMI, Medical- error-the third leading cause of death in the U.S Martin A. Makari, Michael Daniel, May 16, 2016.

[3] there

[4] The Medical Association in Israel, The Ethics Rules 2014, chapter 1, clause 19, entrance: 30^th March 2017

[5] The State Comptroller's Office, Report 62 for 2011, May 2012.

[6] The State Comptroller's Office, Report 62 for 2011, page 209, May 2012

[7] The State Comptroller's Office, Report 62 for 2011, May 2012

[8][8] We should mention in this regard, that as mentioned in the report o the offices inter-disciplinary report for examining the ways to reduce the public spending due medical negligence claims headed by Ms. Tana Shpanitz in 2005, the decisions and activities of the physician must be based on reasonable judgments and at acceptable level, i.e. the physician must base his decisions on the updated knowledge, supported by the professional literature, on previous experience and everything according to the accepted norms at the time in the medical world. Nonetheless, as mentioned in the report of the committee to examine the responsibility for damage in medical treatment headed by judge Dr. Gabriel Kling of 1999 which had been appointed by the Managing director of the Ministry of Health, it should be remembered, that a physician can make a mistake, and not every mistake in judgment constitutes negligence. The report of the offices inter-disciplinary committee on examining the ways to reduce the public spending due to medical negligence headed by Ms. Tana Shapnitz, 2005 : Report of the committee on examining the responsibility of damage in medical treatment headed by Judge Gabriel Kling, 1999.   

[9] Miri Cohen, manager senior area emergency services and first aid, Ministry of Health, letter 19^th January 2017[ received in the Knesset Research and information Center on 2^nd of March 2017]

[10]  There.

[11]   The report of the offices interdisciplinary committee for examining the ways to reduce public spending  due medical negligence headed by Ms. Tana Shapnitz, 2005; The medical system in Israel, Ms. Bin-Noon, Yitzhak Berlovich , Mordechai Shani, 2010.

[12]   Ordinance of Torts ( new version) -1968

[13] Miri Cohen , Senior area manager emergency services and first aid , Ministry of Health, letter 19 January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017)

[14] Ministry of Justice, State Attorney's guidelines, Guideline no. 14.2 – Legal Criminal and Disciplinary Process against Physicians or other Medical Professions Due  Medical Negligence, last revision: 1^st January 2003

[15]Miri  Cohen, Senior area manager emergency services and first aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017)

[16]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[17] There.

[18]  State Comptroller's office Report 62 for year 2011, page 261, May 2012

[19]  There.

[20]  Chief Superintendent Davidi Grader Sagiv, Statistics Bureau Officer, Measurement and Information Section, Strategic Department, Planning Division, National Headquarters, Israeli Police, letter, 29^th May 2017

[21] Kobi Mashmush, Manager Economy and Statistics Department, Court houses Management, letter , 5^th January 2017

[22] Kobi Mashmush, Manager Economy and Statistics Department, Court Houses Management, letter, 5^th January 2017

[23]Ministry of Health, The hospitalization institutes and the hospitalization admitting units in Israel 2015, part A:Trends in Hospitalization, 2016, Ministry of Health, Information Department, Health Division, Hospitalization Beds and  Licensing Counters , January 2017             

[25] Shlomi Cohen, Manager Government Insurance Division, Ministry of Finance, letter, 6^th June 2017

[26] Miri Cohen, Senior Area Manager Emergency Services and First Aid ,Ministry of Health, letter, 19^th January 2017, (received at the Knesset Research and Information Center on 2^nd March 2017; Yahli Rottenberg, Senior Deputy to the Accountant General, Ministry of Finance, letter 31^st January 2017  

[27]  Ministry of Health, Information Department, Health Division, Hospitalization Beds and Licensing Counters, January 2017

[28] WHO Classifications, accessed on 23^rd May, 2017.

[29]  Naama Rotem, Manager Area Health and Natural Movement, Demography and Census, Central Bureau of Statistics, the special processing by the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customer Relations Branch, Central Bureau of Statistics; 26 January 2017

[30] Nama Rotem ,  Head Area Health and Natural Movement, Demography and Census Division, Central Bureau of Statistics. The special processing of the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customers Relations, Central Bureau of Statistics, 26 January 2017.

[31] There

[32]  Naama Rotem, Head  Area Health and Natural Movement, Demography and Census Division, Central Bureau of Statistics. The special processing of the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customer Relations, Central Bureau of Statistics, 26 January 2017.

[33] Naama Rotem, Head Area Health Natural Movement, Demography and Census Division, Central Bureau of Statistics, letter,25^th May 2017.

[34] Naama Rotem, Head Area Health Natural Movement , Demography and Census Division, Central Bureau of Statistics, the special processing of the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customers Relations, Central Bureau of Statistics, 26^th  January 2017.

[35] Naama Rotem, Head Area Health Natural Movement, Demography and Census, Central Bureau of Statistics, letter, 25^th May 2017

[36]It should be noted that according to the Central Bureau of Statistics, the increase in the numbers of blood infection as a basic cause is connected to the change in the symbolizing policy and adapting the manual symbolizing done at the Central Bureau of Statistics to the automatic symbolizing done in most countries. Naama Rotem, Head Area Health Natural Movement, Demography and Census Division, Central Bureau of Statistics  The special processing of the Central Bureau of Statistics conveyed to us David Landau, Head Information Distribution and Customers relations Branch, Central Bureau of Statistics, 26^th January 2017.

[37] There.

[38] Miri Cohen, Senior area Manager Emergency Services and First Aid, Ministry of Health, letter,19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017)

[39] There

[40] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017; Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health , letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017.

[41] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance : 19^th March 2017.

[42] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter 19^th January 2017 (Received at the Knesset Research and Information Center on 2^nd March 2017.

[43]There

[44]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017).

[45] There.

[46] An exceptional event is defined  as " development process or undesired result or unplanned during medical process (and within it all the activities prior the medical process and those coming after it), which resulted in damage or may be resulting in damage to the patient, The Ministry of Health,  Summary Reports of 100 Investigation Committees- Conclusions Drawn from Exceptional Events, Complaints Commission for the Medical Professions, Service Division, Quality Directorate, Service and Safety, June 2016.

[47] Severe medical damage is defined as "death of a patient or causing irreversible severe disability" . There.

[48]  Ministry of Health, Reports Summary of 100 Investigation Committees- Drawing Conclusions from Exceptional Events, Complaints Commission for Medical Professions, Service Division, Quality Directorate, Service and Safety, June 2017.

[49]  Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017.

[50] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017.Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017.

[51] There.

[52] Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017.

[53]  Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017

[54] State Comptroller office, Report 62 for year 2011, May 2012

[55]  Ministry of Health , Courts Disciplinary Unit, entrance: 23^rd May 2017

[56]  There.

[57] Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017.

[58] Ministry of Health, Courts Disciplinary Unit, Entrance: 23^rd May 2017; Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health,      letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[59] State Comptroller's Office, Report 62 for year 2011, May 2012

[60]  There.

[61] Ministry of the Prime Minster, General Inspector for the State Audit Issues division, The remarks of the Prime Minister to the State Comptroller's report 62- first part, May 2012

[62] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter,19 January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[63] The Committee for State Audit Issues discussion, Request for the opinion of the State Comptroller on the issue: Concealment and Cover-up of Medical Negligence while Causing Damage to Patients Population- follow-up session, 16 March 2016

[64] Ministry of Health, circular of Medical Administration no. 11/2012, Mandatory notification by a medical institution on deaths and special events, 9 / May / 2012

[65]   There.

[66] There

[67]  There

[68]  Death that falls under the definition of an event, will be reported as an event and there is no need to report about it also as death. Ministry of Health, Medical Administration circular no. 1/2012, Mandatory notification by a medical institution about deaths and special events, 9^th May 2012.

[69]  There.

[70] Dana Arad, Senior Area Coordinator, Patients Safety, Ministry of Health, letter, conveyed to the Knesset Research and Information Center through Irit Nadav, Coordinator Bureau  B (Deputy Managing Director) , Ministry of Health, 22^nd March 2016

[71] Dana Arad, Senior Area Coordinator, Patients Safety, Ministry of Health, letter May 22, 2012

[72]  Miri Cohen, Senor Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017,(received at the Knesset Research and Information Center on March 2, 2017); Faras Haik, lawyer, Senior Coordinator, special events, medical administration, Ministry of Health, meeting, March 16, 2017; the internet site of the Ministry of Health, The Treatment Safety Array, entrance: March 8, 2017. In the internet site of the safety treatment array in the Ministry of Health it is noted that the activity of the safety treatment array is though information collection while cooperating with the medical institutions; locating the bodies and reasons for failures; use of findings as  basis for development of prevention plans and promotion of safety by the aspect learning from events. The internet site of the Ministry of Health, The Treatment Safety Array, entrance: March 6, 2017. According to the Ministry of Health, the Safety Treatment Array is acting under confidentiality and conducts systemic learning processes to improve work processes and prevention of exceptional events. The reports received in the Safety Treatment Array are assembled and studied by professionals and within this framework a preliminary examination is conducted of the hospitalization summary or description of the case and a process is taking place of evaluation whether the occurrence is a result of natural process in the condition of the patient or if it occurred in special circumstances which require a broader clarification. Alongside its current activity, the Safety Treatment Array promotes a proactive approach (initiative), according which medical processes are examined in order to consolidate recommendations for the improvement of the process so as to turn it to a safer one. Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017 (received at the Knesset Research and Information Center on March 2, 2017).

[73] There.

[74] Dana Arad, Senior Area Manager, Patients Safety, Ministry of Health, letter,  May 22, 2017.

[75]  Naama Rotem, Head Health and Natural Movement Area, Demography and Census Division, Central Bureau of Statistics. Special processing of the Central   Bureau of Statistics conveyed to us by David Landau, Manager Information Distribution and Customers Relations Branch, Central Bureau of Statistics, January 26, 2017.

[76]  Miri Cohen, Senior Manager Area Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017 ( received at the Knesset Research and Information Center on March 2, 2017).    

[77] There.

[78] There.

[79] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017 (received at the Knesset Research and Information Center, on March 2, 2017).

[80] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017 ( Received at the Knesset Research and Information Center, on March 2, 2017).

[81]  The State Comptroller's office,  Report 62 for the year 2011, May 2012.

[82] There.

[83] The State Comptroller's office, Report 62 for the year 2011, page 260, 2012.

[84]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017).

[85]  The State Comptroller's office, Report 62 for the year 2011, May 2012.

[86]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[87] There.

[88] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017)

[89] Yahli Rotenberg, Senior Deputy to the Accountant  General, Ministry of Finance, letter, 31^st January 2017.

[90]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[91]  Chen Shmilo, Lawyer,  Head Area Public Policy, The Israel Medical Association, letter, 1^st February 2017.

[92]  Yahli Rotenberg, Senior Deputy Accountant General, Ministry of Finance, letter, 31^st January 2017

[93] ShlomiC ohen, Head Government Insurance Branch, Ministry of Finance, telephone conversation, 29^th May 2017.

[94]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th May 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017); Yahli Rotenberg, Senior Deputy Accountant General, Ministry of Finance, letter, 21^st January 2017.

[95] Yahli Rotenberg, Senior Deputy Accountant General, Ministry of Finance, letter 31^st January 2017; Shlomi Cohen, Head Government Insurance Branch, Ministry of Finance letter, 6^th June 2017.

[96]   Yahli Rotenberg, Senior Deputy Accountant General, Ministry of Finance, letter, 31^st January 2017.

[97] State Comptroller's office, Report 62 for the year 2011, May 2012

[98] Chen Shmilo, lawyer, Head Public Policy Branch, the Israel Medical Association, letter, 1st February 2017.

[99] There.

[100] The State Comptroller's office, Report 62 for the year 2011, May 2012.

[101]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017.

[102]

[103] Danit Buskila, Manager Government Relations Unit, the Israel Bar Association, 30^th April 2017.

[104]  The Law Library of Congress, Global Legal Research Center, Medical Liability: Canada, England and Wales, Germany and India, August 2009, updated on June 6^th, 2015

[105]  Baruch Levi, the "No- Fault" approach in the World Countries, 2013. Conveyed to the Knesset Research and Information Center by Chen Shmilo, lawyer, Head Area Public Policy, the Israel Medical Association, 1^st February 2017.

[106] M. Erichsen, The Danish patient Insurance System, Med Law, 2001;20 (3): 355-369

[107] There.

[108]  Law Proposal for Compensation to Injured by Birth-defect-2010 (18/2015/p)

[109] Chen Shmilo, lawyer, Head Area Public Policy, the Israel Medical Association, letter, 1^st February 2017.

[110]   The source of about 85% of the funding is the taxpayers money and  the source of about 15% private payments (out of o=pocket) of the patients mainly due

medicine purchase and dental care services.

Existing data source for clinical epidemiology: The Danish Patient Compensation Association database. J. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012.  J.Tilma

85. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28 (1). 81-85.

[111] The Patient Compensation Association (Patienterstatningen)  What is an injury, accessed on May 24^th, 2017; No Fault Compensation for treatment injuries in Danish Public Hospitals 2006-2012 J. Tilma, M. norgaard, K.L. Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, December 2015.

[112] The Patient Compensation Association (Patienterstatningen). History, accessed on April 9^th, 2017.

[113] The Patient CompensationA ssociation (patienterstatningen), History, accessed on April 9^th, 2017. Existing data sources for clinical epidemiology: the Danish Patient Compensation Association database, J/ Tilma, M. Norgaard, K.L., Mikkelesen, s.p. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012, j. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28(1), 81-85.

[114] The Patient Compensation Association (Patienterstatningen), History, accessed on April 9^th, 2017

[115] The Patient Compensation Association ( Patienterstatningen), About the Danish Patient Compensation Association, accessed, April 18^th, 2017.

        Denmark is divided into five  administrative regions which were determined in 2007, and replaced the previous division of districts. The governmental bodies      of the regions are the regional councils responsible, inter alia, for the national health services, regional welfare and development services. Statistics Denmark, Statistical Yearbook 2016, June 2016.

[116] The Patient Compensation Association (Patienterstatningen) , About the Danish Patient Compensation Association , accessed April 18^th, 2017.

[117] The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017

      In case the patient has a complaint against a medical body, he has to contact the Patient Safety Authority who decide if the treatment given should be  audited.  The Patient Compensation Association (Ptienterstatningen), File your Claim, accessed on April 18^th, 2017.

[118] The Patient Compensation Association (Patienterstatningen), Mission and Vision, accessed on April 20t, 2017.

[119] There.

[120]  It is possible that a compensation will be given also due erroneous diagnosis or delay of treatment, however this also in cases in which erroneous diagnosis led  to the injury. Patient Injuries, accessed on April 9^th, 2017. The Patient Compensation Association (Patienterstatningen)

[121] We should note that, cases in which compensation will not be given in this regard are: Cases in  which the source of the injury is the disease itself; The reason  for the injury is that the medicine did not bring the desired result; if the medicine had mental side effects; cases in which life risking disease was treated by a medicine known for its severe side effects

[122]  The Patient Compensation Association (Patienterstatningen) , Patient Injuries, accessed on April 9^th, 2017.

[123]  The Patient Compensation Association (Patienterstatningen), Assessment of your Case, accessed on April 9^th, 2017; The Patient Compensation Association  (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017.

[124] The Patient Compensation Association ( Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017.

[125] The Patient Compensation Association (Patienterstatningen), Areas of Coverage, accessed on April 9^th, 2017.

[126] There.

[127] The Patient Compensation Association (Patienterstatningen), FAQ for Patients, accessed on May 24^th, 2017.

[128]  The Patient Compensation Association ( Patienterstatningen) Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017.

[129] Calculation according to the rate of exchange of the Danish Kroner which stood as at 28^th April 2017, on 0.5286 INS. Bank of Israel, Official Rates of Exchange, entrance: 30^th April 2017.

[130] Existing data sources for clinical epidemiology: the Danish Patient Compensation Association database, j. Tilma, M. Norgaard, K.L.,M ikkelesen, S.P. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012.

85. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28(1), 81-85.

[131]  The Patient Compensation Association ( Patienterstatningen), FAQ for Patients, accessed on May 24^th, 2017.

[132] For the claim form please see attachment no. 1 to this document.

[133] The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017.

[134] The Patient Compensation Association (Patienterstatningen) , FAQ for Patients, accessed on May 24^th, 2017.

[135] There.

[136]  In case the patient had been treated in few disciplines , the information will be collected from all of them

[137] The Patient Compensation Association ( Patienterstatningen), Processing of your Case, accessed on April 9^th, 2017.

[138]  The Patient Compensation Association ( Patienterstatmimgen), FAQ for Patients, accessed on May 24^th, 2017.

[139]  The Patient Compensation Association (Patieterstatningen), Processing of your Case, accessed on April 9^th, 2017.

[140] The Patient Compensation Association ( Patienterstatningen), Have you sustained injury following treatment or medication? 2016, reprieved on April 9^th, 2017

[141] The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9^th, 2017.

[142] There.

[143] The Patient Compensation Association (Patienterstatningen), Danish Act of the Right to Complain and Receive Compensation within the Health Service, accessed on May 24^th, 2017.

[144] Statistical Yearbook 2016, Statistics Demark

[145] Existing data for clinical  epidemiology: the Danish Patient Compensation Association database, J. Tilma, M. Norgaard, K.L., Mikkelesen, S. P. Johnsen, U.S  National Library of Medicine, National Institutes of Health, 2015; No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012, J. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28(1), 81-85

[146] There.