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Introduction to Law and
medicine
By
MADAM JULIE JAMES ABDULLAH
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Learning Outcome
1. Basic concepts of law and medicine
2. Differences between civil and criminal law.
3. Outline laws related to healthcare in Malaysia
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Basic concept of laws
i. Definition of law
ii. Medicine Susceptibility
iii. Regulatory body in MOH
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i.Definition of Law
The earliest notion of law was relation to the rules of human
conduct, established and enforced by authority, which prohibit
extremes in behavior so that one can live without fear for oneself or
one property (Ramachandran, 2012).
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Sources of Law
The laws affect Assistant Medical Officers personally such as constitutional
amendments, whereas other laws such as administrative law regulates the
assistant medical officers professional acts.
In a democratic country like Malaysia, who formulates and enforces the
laws? The ruling government in Malaysia, who is elected by the people, is
the one tasked to formulate and enforce laws.
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ii. Medicine susceptibility
1. Dealing with life and health
2. Systems constrain
➢ Staffing problem
➢ Burn out/ fatique
➢ Communication and continuity of care
3. Public expectation and demands
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ii. Medicine susceptibility
What does susceptible to medication mean?
Susceptible means they can't grow if the drug is present. This means
the antibiotic is effective against the bacteria.
Resistant means the bacteria can grow even if the drug is present.
This is a sign of an ineffective antibiotic.
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ii. Medicine Susceptibility
1. Dealing with life and health
Medicine act in a variety of ways; some can cure illness by killing or
halting the spread of organism, some used to treat cancer by killing
cells-dividing or prevent from multiplying.
Overdoses can occur : accidently or intentional, either by recreational
or over-the counter drugs
[Akta Jualan Dadah 1952 & Peraturan Kawalan Dadah dan Kosmetik
1984]
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ii. Medicine Susceptibility
2. Systems Constrain
a. Staffing problem
✓ Unsatisfactory quality care; patient safety has been linked to staff
shortage impact
✓ Lower patient satisfaction scores
✓ Higher patient mortality
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ii. Medicine Susceptibility
b. Burnout & fatigue
✓ Dissatisfaction
✓ Patient experienced higher mortality and failure to rescue than
facilities with lower patient –to-nurse ratios
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ii. Medicine Susceptibility
c. Communication & continuity of care
✓ Better communication can reduce medical errors & patient injury
✓ Poor communication can results in negatives outcomes e.g. decreased
adherence to treatment, patient dissatisfaction & in-efficient use of
resources
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ii. Medicine Susceptibility
3. Public expectation & demands
Patient expectation continues to increase, this need to be managed to
improve outcome
Poor communication can results in negatives outcomes e.g. decreased
adherence to treatment, patient dissatisfaction & in-efficient use of
resources
Understanding patient’s expectations can enhanced their satisfaction
level
Demands for health care in case of facing illness/injury in accordance
with demand factors e.g. income, cost of care, education, social
norms and tradition, and the quality & appropriateness of service
provided
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iii. Regulatory body in MOH
There are about 150 Acts governing the practice of medical professional
The main Acts include:
i. Medical Act 1971 (Act 50)
ii. Dental Act 1971 (Act 51)
iii. Nurses Act 1950 (Act 14) & Nurses Registration Regulations 1985
iv. Akta Pembantu Perubatan (Pendaftaran) 1977 (Akta 180)
v. Registration of Pharmacists Act 1951 (Act 371) & Registration of
Pharmacists Regulations 2004
vi. Akta Tisu Manusia 1974 (Akta 130)
vii. Akta Profesion Kesihatan Bersekutu (Akta 774)
viii.Akta pengawalan & Pencegahan Penyakit Berjangkit 1988 (Akta
342) etc
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Differences between
civil and criminal law
Differences Between Civil And Criminal Law
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What is civil law? What is criminal law?
Concerned with cases between Relates to offences that negatively
individual person where one affect the society, rather than just
person commits offence which one person
is harmful towards another
person, their rights or property
It’s put in place by Parliament to
prevent breaches of conduct which
Settles disputes between they deem as harmful to the
individuals and organisations society
Person breaches criminal law will
face criminal prosecution by the
state and will be heard in
Magistrate Court
Differences Between Civil And Criminal Law
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What is civil law? What is criminal law?
If you’re convicted, you’re not Convict will received prison
likely to be sent to prison but sentence
most often liable to
compensation Example
murder
Example
Personal injury manslaughter
fraud
Breaches of contract assault
Employment tribunals sexual offences
burglary
Negligence
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Civil Law vs Criminal Law
Civil Law Criminal Law
Putting a person who has Aim of punishing the offender in
suffered harm back in position a way that is designed to
they were in before the harm prevent them from carrying out
occur- in other words, the aim is the offence again
to set right an unfair situation
Preventing crime has a more
general aim of creating a stable
and law-abiding society
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Civil Law vs Criminal Law
Civil Law Criminal Law
Less serious mistakes Serious mistake
Involving individual interests Involving public interest and
safety
Claims to court are brought by
the individuals or single Prosecution is made by federal
organisation involved attorneys
Out-of-court settlement is There is NO out-of-court
encouraged settlement
Begins when a person's privacy is Begins when a person is accused
violated of a criminal offense
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Laws Related To Medical &
Healthcare In Malaysia
i. Medicine Impacting Law
ii. Law impacting medicine
iii. List of laws and regulations related to healthcare delivery
iv. Commonly used terminology in Medical Law
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i. Medicine Impacting Law
1. Determine life/death
2. Sanity
3. Forensic medicine
4. Organ donation/preservation/transplantation
5. Consent & Confidentiality
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1. Determine Life/Death
Brain Death is a term which defines the clinical state by which a
person is recognized as dead when the function of the brain as whole,
including that of the brain stem, is irreversibly lost.
[GUIDELINE OF THE MALAYSIAN MEDICAL COUNCIL MMC Guideline
008/2006]
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2. Sanity
The Malaysian position on insanity should also be scrutinised.
The relevant provision shall be section 84 which provided “Nothing is
an offence which is done by a person who, at the time of doing it, by
reason of unsoundness of mind, is incapable of knowing the nature of
the act, or that he is doing what is either wrong or contrary to law.”
[Akta Kesihatan Mental 2001]
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3. Forensic Medicine
Forensic medicine refers to the application of medical knowledge in
resolving medico-legal cases.
▪ The main function of the field is to conduct post-mortem
examinations on bodies brought in by the police to determine the
cause of death.
A medicolegal autopsy can only be performed in a Government
hospital by a fully registered Government Medical Officer according
to Section 330 Criminal Procedure Code e.g. homicide cases, death
in suspicious, skeletal remains, living detainees or suspects & victims
of crimes
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4. Organ donation / preservation /
transplantation
Cardaveric donor- organ donation, that is taking organs from brain
death people as well as tissue donation from brain death people as
well as heart dead people
Living donor: someone who is healthy & chooses to donate a kidney
to a person who needs a kidney
▪ as directed donor or non-directed donor (altruistic or Good
Samaritan)
[Malaysian Human Tissues Act 1974]
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6. Consent And Confidentiality
➢ Malaysian male & female attaining at the age of 18 years shall be the
age of majority
[Malaysian Medical Council Guideline: Consent for Treatment of Patients
By Registered Medical Practitioners]
➢ Infant [Guardianship of Infants Act 1961]
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Confidentiality
Patients have the right to expect that there will be no disclosure of
any personal information, which is obtained during the course of a
practitioner's professional duties, unless they give consent.
The justification for this information being kept confidential is that it
enhances the patient- doctor relationship.
[Confidentiality Guidelines: Malaysian Medical Council]
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Confidentiality
Why confidentiality is important
Confidentiality is central to the development of trust between doctors
and patients.
Patients must be able to expect that information about their health is
kept confidential unless there is a compelling reason that it should not
be.
How do you maintain confidentiality in healthcare?
Record and use only the information necessary. Access only the
information you need.
Keep information and records physically and electronically secure
and confidential (e.g. leave your desk tidy, take care not to be overheard
when discussing cases and never discuss cases in public places.
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ii. Law impacting medicine
Medical law is the body of laws concerning the rights and
responsibilities of medical professionals and their patients.
▪ The main areas of focus for medical law include confidentiality,
negligence and other torts related to medical
treatment (especially medical malpractice), and criminal law and
ethics.
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ii. Law impacting medicine
Medicine Law is dealing with medico legal issues.
▪ It is related to court decisions, and legislation on: Medical Law,
forensic medicine, sexology and law, psychiatry and law,
psychology and law, dentistry and law, nursing law, pharmaceutical
law, medical ethics, clinical criminology, drugs, alcohol, child
abuse, medical experimentation, genetic engineering, organ
transplantation, abortion, contraception, sterilization, euthanasia,
religion, AIDS, etc.
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ii. Law impacting medicine
Health laws are used to formalize commitment to goals, such as the
goal of universal health coverage, creating a drive for action.
To enable cooperation and achieve health goals, people use law to
create different organizations (such as hospitals) and relationships
(such as contracts for providing health services)
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iii. List of laws and regulations related
to healthcare delivery
There are about 150 Acts governing the practice of Medical
Professionals.
Refer to List of Medical Professionals under MOH, Acts, Regulators and
APC [Source : MPC, 2014]
https://www.mpc.gov.my/wp-content/uploads/2016/10/C4-2.pdf
https://www.mpc.gov.my/wp-content/uploads/2016/04/Appendix-2-RURB-
Medical-Professional-Issue-Paper.pdf
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iii. List of laws and regulations related
to healthcare delivery
➢ The Poison Act 1952
https://www.pharmacy.gov.my/v2/sites/default/files/document-
upload/act-366_0.pdf
➢ Poison Regulations 1952
https://www.pharmacy.gov.my/v2/sites/default/files/document-
upload/poison-regulations-1952-21082019_0.pdf
https://www.pharmacy.gov.my/v2/sites/default/files/document-
upload/poisons-act-1952-act-366.pdf
➢ Sales of Drugs Act 1952 (Revised – 1989)
http://extwprlegs1.fao.org/docs/pdf/mal189820.pdf
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iii. List of laws and regulations related
to healthcare delivery
➢ Mental Health Act 2001
https://medicalprac.moh.gov.my/v2/uploads/mental%20health%20act%2
02001.pdf
➢ Private Healthcare Facilities and Services Act 2006
https://www.mma.org.my/images/pdfs/Link-LawOfMsiaAct/private-
healthcare-facilities-and-services-act-1998.pdf
➢ MMC Guidelines = Consent 2013; Confidentiality 2011
https://mmc.gov.my/wp-
content/uploads/2019/11/Consent_Guideline_21062016.pdf
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iii. List of laws and regulations related
to healthcare delivery
➢ Pathology Laboratory Act 2007
https://www.patologi.gov.my/assets/policy/01_Pathology_Lab_Act.pdf
➢ Traditional and Complementary Medicine Act 2016
https://tcm.moh.gov.my/en/upload/aktaBI2016.pdf
➢ Human Tissues Act 1974
https://www.ummc.edu.my/files/ethic/MCHRS/7%20Human%20Biological%20
Materials/Act%20130%20Human%20Tissues%20Act%20(1974).pdf
➢ Personal Data Protection Act 2010
https://www.kkmm.gov.my/pdf/Personal%20Data%20Protection%20Act%2020
10.pdf
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iv. Commonly used terminology in
Medical Law
Adjudicate: To decide a legal case.
Affidavit: A voluntary statement or declaration of facts that has been
written down and confirmed under oath.
Allegation: A statement made in a pleading by one of the parties to
the action which tells what that party intends to prove.
Answer: Written response in which the defendant admits or denies
the allegations contained in the complaint.
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iv. Commonly used terminology in
Medical Law
Arbitration: A process for deciding a legal dispute without having to
go to court.
Assumption of Risk: A defendant’s allegation that the injured plaintiff
recognized the danger of the plaintiff’s course of action but,
nonetheless, willingly chose to risk such danger.
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iv. Commonly used terminology in
Medical Law
Cancer Misdiagnosis: Caused by medical negligence when a medical
specialist fails to follow the acceptable standard of care required of
his/her medical specialty. Cancer misdiagnosis related to medical
negligence can occur when a medical professional fails to do any of
the following: pay attention or respond to a patient’s complaints or
symptoms, order the proper tests that would lead to correct
diagnosis, refer a patient to a specialist in a timely manner, or treat a
patient in the appropriate manner given their medical condition.
Case Law: Law based on previous decisions of appellate courts.
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iv. Commonly used terminology in
Medical Law
Civil Lawsuit: Civil: Generally a lawsuit pertaining to disputes, not
involving crimes, including family matters, contracts, medical
malpractice, collection of debts, and compensation for personal
injury or property loss.
Collateral Source Rule: Under this rule, compensation awarded to an
injured party shall not be reduced by the jury by the amount of
compensation available to him from his insurance company or other
independent sources. If there have been payments made by an
insurance company or other source for the injuries suffered, the judge
will reduce the verdict accordingly.
Common law: Law that derives its authority solely from usages and
customs of the past.
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iv. Commonly used terminology in
Medical Law
Comparative Negligence: The doctrine of comparing degrees of fault
among the responsible parties.
Compensation: Monetary award transferred from defendant to plaintiff to
make up for some wrong, damage or injury caused by the defendant’s
actions or inaction.
Complainant: Also known as the plaintiff.
Civil Complaint: The first pleading in a civil case filed by the plaintiff. It
alleges the material facts and legal theories to support the plaintiff’s
claim against the defendant.
Contingency Fee: A fee arrangement in which the plaintiff and his or her
attorney agree that the fees due to the attorney will be determined by
the amount of the judgment granted if in the favour of the plaintiff.
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iv. Commonly used terminology in
Medical Law
Continuance: A delay of a scheduled session of a court.
Cross-Examination: The questioning of a witness of one party by the
opposing party during a trial, hearing or deposition.
Damages: Monetary compensation claimed by a person who has
suffered a loss or injury to his person, property or rights as a result of
the negligence or unlawful conduct of another.
Decedent: A person who has passed away. In a medical malpractice
case, it is the person who has died due to the negligence of a medical
provider.
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iv. Commonly used terminology in
Medical Law
Decree: An order of the court. A final decree is one that fully disposes
of the litigation.
Default: Failure of either party to file required documents or appear
in a civil case within a certain period of time.
Defendant: The person or party sued in a civil case or accused in a
criminal case.
Deposition: The sworn testimony of a witness, taken out of court and
usually prior to trial.
Direct Examination: Questioning of a witness by the party who calls
the witness.
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iv. Commonly used terminology in
Medical Law
Directed Verdict: A judgment entered by the judge without allowing
the jury to participate.
Disciplinary Hearing: A hearing or professional review conducted by
any state or federal administrative agency, licensing or regulatory
authority responsible for regulating professional conduct.
Discovery: The pre-trial process in which each party discovers the
evidence that will be relied upon at trial by the opposing party.
Dismissal with Prejudice: An order to dismiss a case in which the court
bars the plaintiff from suing again on the same cause of action.
Dismissal without Prejudice: An order to dismiss a case in which the
court preserves the plaintiff’s right to sue again on the same cause of
action.
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iv. Commonly used terminology in
Medical Law
Eligible Survivor: In a medical malpractice lawsuit, this term can
include living spouse and children under the age of 25 years of age.
Evidence: A fact presented in court through the testimony of a
witness, an object or written documents.
Exhibit: A document or object that is offered into evidence during a
trial or hearing.
Failure to Diagnose: A form of medical malpractice committed on
behalf of a medical doctor. Failure to diagnose has the potential to
cause serious damage and even death to patients who do not receive
prompt and adequate medical care as needed because of medical
malpractice.
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iv. Commonly used terminology in
Medical Law
Fraud: Intentional deception resulting in damage to another, whether
to his or her person, rights, property or reputation. Fraud usually
consists of a misrepresentation, concealment or non-disclosure of a
material fact. Can also be misleading conduct, devices or
contrivance.
Greater weight of the evidence: the more persuasive and convincing
force and effect of the entire evidence in the case.
Incompetence: The inability or lack of legal qualification or fitness to
discharge the required duty.
Illness Period: For insurance purposes, this normally begins when
covered expenses are incurred.
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iv. Commonly used terminology in
Medical Law
Indemnity: An agreement wherein one party financially protects another
against an anticipated loss.
Interrogatories: A form of discovery in which one party submits a series of
written questions to the other party, and to which the latter is bound to
answer under oath.
Judgment: The official decision by a court, or certification by the court
of a jury’s verdict. The more formal definition is the determination or
sentence of the law, pronounced by a competent judge or court, as the
result of an action or proceeding instituted in such court, affirming that,
upon the matters submitted for its decision, a legal duty or liability does
or does not exist.
Judgment notwithstanding the Verdict: A judgment entered by order of
the court for one party, although there has been a jury verdict for the
other party.
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iv. Commonly used terminology in
Medical Law
Liability: A legal responsibility or obligation.
Liability Risk: Liability loss or exposure where negligent acts may
occur for which an organization may be held responsible. The act
must be injury to or property damage of others. Insurance coverage
for this type of risk is called, “third party insurance.”
Lien: An encumbrance, upon real or personal property, that secures
the payment of a debt or the performance of a duty.
Litigant: One of the parties involved in a legal action.
Litigation: The process of settling a dispute through the court system.
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iv. Commonly used terminology in
Medical Law
Medical Incident: Any act, error or omission during the providing of
professional services.
Medical Lien: The right of a hospital, doctor or health insurance
company to assert an interest in a personal injury recover to the
extent of the cost of the treatment or service provided.
Medical Malpractice: Improper or negligent medical treatment of a
person under a medical professional’s care, which results in injury or
death.
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iv. Commonly used terminology in
Medical Law
Medical Negligence: An act or omission (failure to act) by a medical
professional that deviates from the accepted medical standard of
care. Those standards are based on what a reasonable person with the
requisite knowledge and skills would or would not do under the same
or similar circumstances.
Misdiagnosis: A medical professional’s failure to properly identify and
diagnose a patient’s medical condition. A doctor can be held liable for
any damages that result from a misdiagnosis if the medical mistake
was a result of negligence.
Mistrial: An erroneous invalid trial that cannot stand in law.
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iv. Commonly used terminology in
Medical Law
Negligence: Failure to exercise that degree of care that a reasonable
person would exercise under the same circumstances. When that
failure causes another person to suffer an injury or financial loss, that
person may be entitled to just compensation through our civil justice
system.
Negligence action: a civil action for damages based upon a theory of
negligence, strict liability, products liability, professional malpractice
whether couched in terms of contract or tort, or breach of warranty
and like theories. The substance of an action, not conclusory terms
used by a party, determines whether an action is a negligence action.
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iv. Commonly used terminology in
Medical Law
Nursing Malpractice: An intentional act or negligence committed by a
member of the nursing profession that causes physical, financial,
cognitive, emotional or psychosocial damage to a patient under their
care.
Nursing Home Malpractice: Any intentional act or negligence
committed by a nursing home professional which causes injury to a
resident.