UAE Healthcare / Pharma LawCabinet Resolution No. (40) of 2019 Concerning the Executive Regulations of Federal Decree-Law No. (40) of 2016 Concerning Medical Liability

Article (1) The same meanings provided for in the above-referenced Federal Decree-Law No. (4) of 2016 shall apply to this Resolution. Other than that, the following terms and expressions shall have the meanings assigned thereto respectively, unless the context otherwise requires: Committee : The Medical Liability Committee provided for in the Decree-Law. Supreme Committee : The Supreme Committee for Medical Liability provided for in the Decree-Law. Decree-Law : The Federal Decree-Law No. (4) of 2016 Concerning Medical Liability.

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Cabinet Resolution of 2019 Concerning the Executive Regulations of Federal Decree-Law of 2016 Concerning Medical Liability 2

Article (2) Without prejudice to the duties provided for in the Decree-Law, whoever practices the profession shall, within his / her sphere of competence, comply with the rules set out below that are in line with the nature of his /her work, as follows: 1. To perform his / her work in strict compliance with the principles of professional practice in general, and with the scientific and practical principles of the specialization practiced in particular, in accordance with the Protocols and Rules approved by the Health Authority. 2. To exercise utmost care for providing and following up on the health service vigilantly and watchfully, in accordance with the standard of practice of his/her aver…

Article (3) hereof, as the case may be, well informed of all complications that may result from the diagnosis or treatment in a clear and simplified manner.

Article (3) Without prejudice to the provisions of the Decree-Law, surgical operations may be performed only after taking into account the following:

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Cabinet Resolution of 2019 Concerning the Executive Regulations of Federal Decree-Law of 2016 Concerning Medical Liability 3 1. The Health Facility at which the Surgery is to be performed shall be adequately equipped in line with the type of surgery, in terms of the medical and nursing staff, medical equipment and supplies necessary in terms of quality and safety, and all matters necessary for conducting such surgery and properly dealing with any complications or other potential repercussions. 2. To make an insightful assessment…

Article (4) 1. It shall be prohibited to allow medical research or experiments to be conducted on any person without obtaining his/her consent and a written permission from the competent authority named by a decision of the Minister in coordination with the Health Authorities beforehand. 2. The Minister shall, after coordination is made with the Health Authorities, issue a Resolution on the controls, rules and procedures regulating the conducting of medical research and experiments on humans.

Article (5) 1. The medical malpractice shall be deemed of a gross nature if it leads to the death of the patient or fetus, eradication of a human organ by mistake, loss of organ function, or any other serious damage, in addition to the availability of any of the following criteria from which the medical malpractice results: a. Unpardonable unfamiliarity with the well-established medical standards according to the level and specialization of professional practitioner. b. Adopting a medically unrecognized method. c. Unjustified deviation from medical standards and rules for practicing the profession. d. The doctor is under the influence of alcohol, drugs, or psychotropic substances. e. Gross n…

Article (6) The Professional Practitioner shall furnish to the Health Authority any data or information about the patient, which has come to his/her knowledge during or on account of practicing the profession or as obtained from the patient, in accordance with the following controls and conditions: 1. There must be a written request from the Health Authority, and the purpose of providing such data and information is to protect the public health. 2. The data and information required to be disclosed shall be precisely specified. 3. The data and information required to be disclosed shall be necessary for carrying out an action or program falling within the work scope of the Health Authority. 4.…

Article (7) Health Authorities may establish a system for the provision of Telehealth Services, in accordance with the terms and conditions set forth in the annex attached herewith.

Article (8) 1. The competent Health Authority shall receive the complaints relating to the medical malpractice. The complaints shall be filed in accordance with the following procedures: a. To be submitted in a paper or an electronic format. b. To be written out in Arabic, but if written in any other language, it shall be accompanied by translation into Arabic. c. The complaint's subject must be precisely stated. d. To be accompanied by all documents related thereto, if possible. e. To be containing the detailed information about the complainant and patient or his/her legal representative, if any, in particular, the personal address and any other data that facilitate communication with him/h…

Article (9) 1. A Committee to be known as (Medical Liability Committee) shall be composed at each Health Authority, by virtue of a resolution by the Minister or the Head of the Health Authority, as the case may be. Members of such shall include doctors specializing in the specializations named by the Health Authority. The resolution issued in this regard shall name the committee's chairman, deputy chairman, members, Rapporteur, and the term of membership. 2. The Committee may solicit the opinion of one or more doctors from other specializations, or the opinion of any person at its discretion, depending on the nature of the case under consideration. The committee may also compose one or more…

Article (10) The Committee's Rapporteur shall carry out the following competencies: 1. Receiving the applications for referral to the Committee and record the same in the relevant records. 2. Requesting the original medical file and the documents and papers related to the case referred to the committee. 3. Calling the interested parties and anybody whose testimony is deemed necessary to be heard by the Committee. 4. Calling the members to meetings in coordination with the Committee's Chairman. 5. Drafting the Committee's agenda in coordination with the Committee's Chairman. 6. Drawing up the Committee's Minutes of Meetings. 7. Drawing up the Committee's final report after being signed by all…

Article (11) 1. The Committee shall convene at the call of its chairman or the deputy chairman in the absence of the chairman, to consider the cases referred thereto. 2. The quorum of the committee meeting shall be valid only if attended by two-thirds of the members, including the chairman or deputy chairman. The opinion of the committee shall be passed by the majority of votes the members present. In case of equal votes, the chairman of the meeting shall have the casting vote. If the medical malpractice is categorized as a gross one, the consent of two-thirds of the members present shall be a must.

Article (12) 1. It is prohibited for any member of the Committee to attend its meetings or to give opinion on any matter referred thereto, in any of the following cases: a. If he/she has a kinship relationship with either of the parties to the complaint up to the fourth degree. b. If he/she is working under the management or supervision of either party to the complaint. c. If he/she has previously treated the patient from the same disease under consideration in the complaint. d. If the Complainee has previously consulted him / her about the medical condition subject of the complaint. e. If there is any other relationship that constitutes a conflict of interest and raises doubts about the pri…

Article (13) The provisions on experts shall also apply to the members of the Committee, in a manner that does not contradict the provisions of the Decree-Law. Each of them shall take the legal oath once before an Appeal Chamber within whose jurisdiction his/her

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Cabinet Resolution of 2019 Concerning the Executive Regulations of Federal Decree-Law of 2016 Concerning Medical Liability 9 place of residence or the Committee's headquarters is located, before taking over his/her post in the Committee.

Article (14) The Committee shall submit an annual report on its activity to the competent Health Authority. The committee shall also be subject to the annual assessment of its work by the same Health Authority.

Article (15) The Health Authority shall hand over a copy of the committee's report to the parties to the complaint, by any of the following means: 1. By personal delivery, provided that the recipient shall sign in acknowledgment of receipt, with mention of the date of receipt and capacity of the recipient. 2. By ordinary mail or the registered letter with receipt acknowledgment requested. 3. By fax or e-mail if either is available at the Health Authority.

Article (16) 1. Any entity conducting an investigation with the Professional Practitioner on merits relating to his / her work shall notify the Undersecretary or the Responsible Director at the Health Authority issuing the license, as the case may be, before the start of the investigation. Such notification shall take effect by virtue of an official letter containing the full name of the Professional Practitioner and his / her Employer, and the subject of investigation. 2. The Health Authority, to which the Professional Practitioner with whom the investigation is being conducted affiliates, may delegate one of its employees or one of the employees of the Professional Practitioner's Employer…

Article (17) It shall be prohibited for any person to practice the profession in the absence of insurance against civil liability for medical malpractice and the risks arising from or due to the practice of the profession. Such insurance shall be provided by an insurance company duly licensed in the State. Health Facilities shall provide insurance for the professional Practitioner before allowing him / her to take over his / her post, and shall get the same renewed upon expiry.

Article (18) Without prejudice to the provisions of the Decree-Law and of civil and criminal liabilities, and unless otherwise stipulated in the legislation relating to the disciplinary regulations of the Health Authority, disciplinary penalties shall apply to any act in violation of the provisions hereof, in accordance with the following laws: 1. For private health facilities, disciplinary penalties provided in the Federal Law No. (4) of 2015 Concerning the Private Health Facilities, shall apply. 2. For professional practitioners at the private health facilities; most precisely doctors, disciplinary penalties provided in the Federal Law No. (5) of 2019 concerning the Practice of Human Medic…

Article (19) The Cabinet Resolution No. (33) of 2009 on the Executive Regulations of Federal Law No. (10) of 2008 on Medical Liability, along with any provision that goes against or contradicts the provisions hereof, shall all be repealed.

Article (20) The Minister shall issue the resolutions required for enforcing the provisions hereof.

Article (21) This Resolution shall be published in the Official Gazette and shall enter into force from the day following its publication date. Mohammed Bin Rashid Al Maktoum Prime Minister Issued by us: On: 29 Shawwal 1440 AH Corresponding to: 2 July 2019

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Cabinet Resolution of 2019 Concerning the Executive Regulations of Federal Decree-Law of 2016 Concerning Medical Liability 12 Annex attached to Cabinet Resolution No. (40) of 2019 Concerning the Executive Regulations of the Federal Decree-Law No. (4) of 2016 Concerning Medical Liability Rules & Conditions for Providing Telehealth services First: Definitions Remote Medical Consultation: A type of medical consultation provid…