s.u.m.ph. nicolae testemitanu department of forensic medicine · medical law the medical law is a...

Prelection by Vasile Șarpe

MD, MS, PhD, Assoc. Professor

S.U.M.Ph. "Nicolae Testemitanu" Department of Forensic Medicine

2013/2014

Law

A law is defined as a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority.

Governments enact laws to keep society running smoothly and to control behavior that could threaten public safety.

Laws are considered the minimum standard necessary to keep society functioning.

Medical law

The medical law is a branch of law which

regulates prerogatives, responsibilities and

juridical relations (professional, patrimonial

non-patrimonial etc.) between patients and

medical professionals, or health care

institutions.

Medical law relationship

Interpersonal, social or another relationship becomes law relationship if breach of legal norms.

Medical act

Legal norm

Medical law relationship

medical professionals (doctors, assistants, nurses etc.)

patients

health care institutions

Ministry of Health

companies of healthcare insurance

educational and medical research institutions

doctors League

Subjects of medical law

• rights and

• obligations of subjects of medical law

Content of medical law relationship

• all normative acts that determine the legal status of the parties

• set of actions and inactions that direct or force parties to express content of medical law relationship

Object of medical law

patient (consumer of health services)

the person who needs, requests or uses health services, regardless of his health, or who participate voluntarily in biomedical research

Main concepts in medical law

patient's legal representative

a person represent , under the law, with no power of attorney, the interests of a patient without full functioning capacity or who has been declared incapable or with limited functioning capacity


patient rights

rights derived from basic human rights to life and health, including social rights related to accessibility, equity and quality in obtaining health care, as well as individual rights related to the patient as being a human, respecting his/her dignity and integrity, applied within the process of providing health services or in connection with voluntary participation, as a human subject, in biomedical research


medical intervention (medical act)

any examination, treatment, clinical research and patient assistance or other action applied to the patient with a prophylactic, diagnostic, curative, rehabilitation or biomedical research purpose and performed by a physician or other healthcare worker


consent

agreement of the patient or his legal representative to perform a medical intervention, expressed voluntarily, based on multilateral and comprehensive information received from the doctor


medical confidentiality

confidential information about diagnosis, health, and private life of the patient, obtained during the examination, treatment, prevention, rehabilitation and biomedical research

medical information

information about physical and mental health of patients


• principle of legality - medical act must take place only within the legal regulations and scientific progress

• principle of guaranteeing the right to health care - human priority prevail over the sole interest of society or science

• principle of self-determination (autonomy). A health intervention can not be made until the subject (ex.: patient) has given his free and informed consent

Principles of the medical law

• principle of guaranteeing the right to

a second medical opinion in same

medical question

• principle of inviolability of the

human body - protection and

guarantee for everyone the human

dignity and identity, without

discrimination

Principles of the medical law

Law source is a form of expression of legal norms within a law system in various times and countries.

Medical law sources can be classified as:

• International

• National

Sources of medical law

Every authority emits a certain well-defined legislative act in terms of material, personal and territorial competence, which is the organ.

International sources (if it is ratified) (treats, conventions, covenant)

National sources ↓ Constitution - fundamental law of any state

↓ Organic law

↓ Ordinary law

↓ Government Ordinances

↓ Government Decision

↓ Ministry of Health Orders and Dispositions

Hierarchy of juridical acts

• Code of Hammurabi (Babylon, 1792-1750 BC)

e.g.: "if a physician make a large incision with the operating knife, and kill him, ... his hands shall be cut off."

• Hippocratic Oath (Greece, 460-370 BC)

• Forensic treaty by Sun-Tzi (China, 1247)

• The Low of Vasile Lupu (Moldova, 1646)

• etc.

Some of archaic medical law and ethical sources

• International Covenant on Civil and Political Rights

• International Covenant on Economic, Social and Cultural Rights

• International Convention on the Elimination of All Forms of Racing Discrimination

• Convention on the Elimination of All forms of Discrimination Against Women

• Convention of Human Rights

• Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment

• European Convention of Social Security

• Etc.

International sources of law

• The Constitution (29/07/1994)

• The Healthcare Law (411-XIII, 28.03.1995)

• The Law regarding patient rights and responsibilities (263-XVI, 27.10.2005)

• The Law regarding the exercise of medical profession (264-XVI, 27.10.2005)

• The Law of pharmaceutical activity (1456-XII, 25.05.1993)

• The Law of Mental Health (1402-XIII, 16.12.1997)

• The Law regarding drugs (1409-XIII, 17.12.1997)

Health care legislation Republic of Moldova

• The Law of mandatory health insurance (1585-XIII, 27.02.1998)

• Law of circulation the narcotic drugs, psychotropic substances and their precursors (382, 06.05.1999)

• The Law of health assessment and accreditation (552-XV, 18.10.2001)

• The Law of reproductive health and family planning (185-XV, 24.05.2001)

• The Law regarding the amount, manner and terms of payment of compulsory health insurance in (1593-XV, 26.12.2002)


• The Law of HIV/AIDS prophylaxis (23-XVI, 16.02.2007)

• The Law regarding control and prevention of tuberculosis (153, 04.07.2008)

• The Law regarding blood donation and transfusion (241, 20.11.2008)

• The Law regarding transplantation of organs, tissues and cells (42, 06.03.2008)

• The Law of State supervision of public health (10, 03.02.2009)


• GD regarding approval of the Regulation on conditions of mandatory health insurance of foreign citizens and stateless persons in the Republic of Moldova (43, 21.01.2002)

• GD regarding approval of some legislation (on how to fill, release and register mandatory health insurance) (1015, 05.09.2006)

• GD regarding the Development of Emergency Medical Assistance Service (564, 22.05.2006)

• GD on the approval of the unique program of mandatory health insurance (1387, 10.12.2007)

• Other Orders of the MH.


An adverse event is an injury caused by

the medical management rather than

underlying condition of the patient.

• Medical misconduct

• Medical error

• Iatrogenic disease

Adverse events in medical practice

Medical misconduct is defined as behavior that deviates from duty by a healthcare professional.

• practicing as a healthcare professional fraudulently

• practicing with gross incompetence or medical negligence

• omissions in medical examination, inappropriate interventions, etc.

• practicing while impaired by alcohol, drugs, physical or mental disability

• being convicted of a crime

• exercising undue influence on the patient, including the promotion of the sale of services, goods, appliances, or drugs

• etc.

Medical misconduct

Medical malpractice is professional negligence

by act or omission by a health care provider in

which the treatment provided falls below the

accepted standard of practice in the medical

community and causes injury or death to the

patient.

Between 15,000 and 19,000 malpractice suits

are brought against doctors each year in the

US.

Medical malpractice

A medical error occurs when a health-care provider chooses an inappropriate method of care or improperly executes an appropriate method of care.

Medical errors are often described as human errors in healthcare: To Err is Human

Medical error

Iatrogenic are diseases and pathological processes due to the professional activity of the medical staff.

May be:

• Psychical

• Somatic – organizational

– traumatic

– toxic

– septic

Iatrogenic disease

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