Ethical and Legal Issues
Ethical and Legal Issues
MEDICAL ETHICS
Medical Ethics may be described as the moral principles that should guide members of the medical
profession in their dealings with each other, with the patients and the State
To form Standards for the behaviours of healthcare professionals provide general guidelines for
healthcare activities
NON-MALEFICENCE: No Harm
Healthcare Service
• Medical Jurisprudence : Legal aspects of Medicine care & Regulation of Medical Professional
• Forensic Medicine: Medical Knowledge for administration of Justice
• Labour Laws
INDIAN CONSTITUTION
CONSTITUTION OF INDIA
Adopted on 26 th November, 1949 but came into force on 26 th January 1950 which is now
celebrated as the Republic Day.
Constitution provides for government machinery for both Union and the State.
TRIBUNALS
Tribunals were introduced in the Constitution by way of amendments (42 nd amendment in 1976)
Objectives
Administrative Tribunals
Art.323A : Empowers the Parliament to provide for the establishment of administrative tribunals for
the adjudication of disputes relating to recruitment and conditions of service of persons appointed to
public services of the Centre, the states, local bodies, public corporations, and other public
authorities.
National Green Tribunal: Established under the National Green Tribunal Act, 2010 for effective and
expeditious disposal of cases relating to environmental protection.
LAW OF CONTRACT
Offer
Acceptance
Agreement
Lawful Consideration
Competency to contract
Intention to contract
Free consent
Lawful object
Not expressly declared to be void by law and necessary formalities to be complied with
Voidable Contract S.2(i): Agreement enforceable by law at the option of one or more of the
parties thereto, but not at the option of other/s
When consent to agreement caused by coercion, fraud or
misrepresentation, undue influence
In such case, one party has printed forms of contract containing specified terms and conditions (Such
clauses may restrict or exclude liability of the party preparing it)
The other party has no opportunity to bargain and has either accept or refuse to enter into contract
on the stated terms and conditions. The terms and conditions are not open to alteration / discussion
/ negotiation.
Apart from treatment provided after getting consent on consent forms, usually most doctor patient
contracts are implied contracts
CONSENT
Definition
Consent is defined as free and voluntary agreement, compliance or permission given for a specified
act or purpose
“VOLENTI NON FIT INJURIA” means ‘he who consents cannot complain’.
Every person has the right to know, in non professional terms, regarding the disease, its status and
treatment options.
Informed consent is a step that will maintain transparency between doctor patient relationships.
TYPES
• EXPRESS
• IMPLIED
COMPONENTS OF CONSENT
• VOLUNTARINESS
• CAPACITY
• KNOWLEDGE
Section 13
“two or more persons are said to consent when they agree upon the same thing in the same sense”
Section 14
EXCEPTIONS
• Emergency
• Incompetence
• Therapeutic privilege
• Waiver
Section 88 of IPC/ 26 of BNS
This section deals with act not intended to cause death done by consent in good faith for the
person’s benefit
Illustration
Suppose a surgeon “ performs an operation on patient “ who was suffering from disease The
intention of X is to relieve Y from pain and suffering by performing operation and not to cause of
death of Y Thus X has not committed any offense
Act done in good faith for benefit of child or insane person by consent of guardian
In both of above sections i e 88 and 89 of IPC, The important features are as follows
The intention is not to kill the patient but to cure his disease
Consent of the particular patient or guardian has been obtained for the procedure
For example suppose a surgeon “ performs an operation on patient “ because it is necessary to save
the life Now consider that the patient Y is unconscious and there is no time to call his family
members and take consent or person appears to be unidentified ( one Then question arises from
whom the consent should be obtained? In such situation, if surgeon X operates Y without consent
with good faith to save the life of patient, then the act of surgeon is not an offense
No communication made in good faith is an offense by reason of any harm to the person to whom it
is made, if it is made for the benefit for that person
EUTHANASIA
Involuntary Euthanasia Euthanasia is “when the life of a patient is brought to an end without his
consent either because he may be incapable of giving it or may even not be in a capacity to
understand what he is going through or what would happen to him In this case, the decisions are
made by the family members or close friends of the patient, or even sometimes by the medical
practitioner and the patient is killed without his knowledge
For a medical practitioner euthanasia can either be active or passive The distinction between these
has been explained by the Supreme Court of India in Aruna Ramachandra Shanbaug v Union of India
Passive euthanasia - Passive euthanasia involves withholding of the medical treatment which would
ensure the continuance of a patient’s life, for example, discontinuance of life saving antibiotics,
withdrawal of heart lung machine from a patient who is in coma Thus, passive euthanasia can be
described as a deliberate omission where all the medical assistance provided to the patient for
lengthening his life is terminated In India, passive euthanasia is legal, however, there is no legislative
sanction regulating the same
A MLC is defined as “any case of injury or ailment where, the attending doctor after history taking
and clinical examination, considers that investigations by law enforcement agencies are warranted to
ascertain circumstances and fix responsibility regarding the said injury or ailment according to the
law”.
EXPERT EVIDENCE
SUMMON
A summons is a writ compelling the attendance of the witness in a court of law, at a specified place
and time, and for a specified purpose under penalty ( sub under, poena penalty)
Medical Record
OPD cards
IPD cards
Treatment record
Laboratory reports
A medical record is a collection of data compiled on a patient to assist in the clinical care of present
and future illnesses
Date of contact
Findings
Maxim “To be complete, the medical record must contain sufficient data, written in sequence of
events, to justify the diagnosis and warrant the treatment and end results”
Document the course of patient illness and medical treatment as inpatient or as an outpatient
Serve as communication between the physician and other professionals contributing to patient care
Providing continuity of care on subsequent patient admission (better patient care ensure quality and
continuity of care)
Review, study and evaluate patient care by the hospital medical staff committees (better
management of the healthcare system, health surveillance assessment of care)
Provide data for 3 rd parties concerned with patient (hospital bills insurance companies or other
physicians, hospitals, government agencies etc ..))(for reimbursement of medical cost under
Government and Private insurance schemes, evidence in medico legal cases)
Provide data to assist in protecting the interests of the patient, hospital and medical staff
Provide clinical data for research study and educational purposes (medical and biomedical research)
Provide data for prevention and control of diseases at the community, national and international
levels (predict outbreaks of epidemics, predictive and precision medicine)
Digital version of the traditional paper based medical record of the individual
EMR represents a medical record within a single facility (doctor’s office or clinic)
Validity of EMR
After enactment of IT Act, 2000 and subsequent amendment in the IT ( Act, 2008 any records in the
electronic form can be produced before any authority as a valid proof
Section 63 2 Secondary evidence Copies made from the original by mechanical processes which in
themselves insure the accuracy of the copy, and copies compared with such copies
1 3 1 Every physician shall maintain the medical records pertaining to his her indoor patients for a
period of 3 years from the date of commencement of the treatment in a standard proforma laid
down by the MCI as in Appendix III
1 3 2 If any request is made for medical records either by the patients authorised attendant or legal
authorities involved, the same may be duly acknowledged and documents shall be issued within the
period of 72 hours
1 3 3 A Registered medical practitioner shall maintain a Register of Medical Certificates giving full
details of certificates issued When issuing a medical certificate he she shall always enter the
identification marks of the patient and keep a copy of the certificate He She shall not omit to record
the signature and/or thumb mark, address and at least one identification mark of the patient on the
medical certificates or report The medical certificate shall be prepared as in Appendix II
EHR Standards 2016 provide that the requirements of the format for medical records as specified in
MCI Code of Ethics Regulation 2002 (as amended upto Feb 2016 to be adhered to
The printed reports should meet the MCI prescribed formats whenever any discharge treatment
S.23, Mental Healthcare Act, 2017 Right to confidentiality embodies the principles of medical
confidentiality and the health professional is allowed to release information relating to a patient with
mental illness to a third party on the following circumstances ;
Under the order of Central authority, or High Court or Supreme Court or any other statutory
authority competent to do so
Free, specific, informed, unconditional and unambiguous with a clear affirmative action, and shall
signify an agreement to the processing of her personal data for the specified purpose and be limited
to such personal data as is necessary for such specified purpose
Where consent given by the Data Principal is the basis of processing of personal data, such Data
Principal shall have the right to withdraw her consent at any time, with the ease of doing so being
comparable to the ease with which such consent was give
The Data Principal may give, manage, review or withdraw her consent to the Data Fiduciary through
a Consent Manager.
The Consent Manager shall be accountable to the Data Principal and shall act on her behalf in such
manner and subject to such obligations as may be prescribed.
S.2(g) “Consent Manager” means a person registered with the Data Protection Board of India, who
acts as a single point of contact to enable a Data Principal to give, manage, review and withdraw her
consent through an accessible, transparent and interoperable platform
Purposes for which data voluntarily provided to Data Fiduciary and where lack of consent not
indicated to use of the personal data provided
For State to provide Data Principal such subsidy, benefit, service, certificate, license or permit for
which the data principal had previous consented to, to process personal data or where such personal
data is available in digital form in, or in non digital form and digitised subsequently from, any
database, register, book or other document which is maintained by the State or any of its
instrumentalities and is notified by the Central Government
For compliance with legal obligations in interest of sovereignty and integrity of India security of the
State
To comply with any judgement decree order issued under any law for the time being in force in India
relating to contractual or civil nature under any foreign law
To respond to medical emergency threat to life immediate threat to health of Data Principal or any
other individual
To take measures to provide medical treatment or health services to any individual during an
epidemic, outbreak of disease, or any other threat to public health
To take measures to ensure safety of, or provide assistance or services to, any individual during any
disaster, or any breakdown of public order
Notified by the Ministry of Health & Family Welfare (MoH&FW) in December 2016
An Electronic Health Record (EHR) is a collection of various medical records that get generated during
any clinical encounter or events
To bring standardisation and homogeneity, inter operability in capture, storage, transmission & use
of healthcare information across various Health IT systems.
omission to give notice or information to public servant by person legally bound to give it.
FALSE EVIDENCE
194 of IPC/ 230 BNS giving or fabricating false evidence with intent to procure conviction of capital
offense
Section 195 of IPC 231 BNS giving or fabricating false evidence with intent to procure conviction of
offense punishable with imprisonment for life or imprisonment
Section 201 of IPC/ 238 BNS causing disappearance of evidence of offense, or giving false information
to screen offender
Section 203 of IPC/ 240 BNS giving false information respecting an offense committed
Section 204 of IPC/ 241 BNS destruction of documents to prevent its production as evidence
ENVIRONMENT
Section 277 of IPC/ 279 BNS fouling water of public spring or reservoir
Section 284 of IPC/ 286 BNS negligent conduct with respect to poisonous substance
HOMICIDE
WOMEN
TYPES
Good Faith
CRIMINAL ABORTION
SETH
S = SOCIAL
E = EUGENIC
T = THERAPEUTIC
H = HUMANITARIAN
20 24 WEEKS 2 RMP
EXCEPTION:
CONTRAVENTION
SECTION 5A of MTP
for therapeutic purposes and for prevention of commercial dealings in human organs & tissues.
Types of donors
A living donor is a person who is above the age of 18 years and has voluntarily authorized for the
removal of his organ/tissue, during his lifetime A living person can legally donate
Deceased/Cadaver Donors
Brain death
Cardiac death
T: Transplant Centre
R: Retrieval Centre
Section 18 : removal of a human organ/tissue without authority 10 years and with fine Rs. 20 lakhs.
Section 19 : commercial dealing of human organs 10 years and fine which will not be less than Rs 20
lakhs but can extend to Rs 1 crore
Section 20 Any p erson violates any other provision of this act 5 years or with fine which may extend
to Rs 20 lakhs
MEDICAL NEGLIGENCE
Law of Torts
MEDICAL NEGLIGENCE
GOVERNING LAWS
LAW OF TORTS
CONSUMER PROTECTION ACT
An expert is required to exercise the same standard of care as a reasonably competent person
trained in that particular trade or profession.
A given doctor is required to display the degree of aptitude that would be possessed by a reasonable
doctor.
A doctor who is particularly skilled will not be negligent if he fails to meet his own exceptional
standard on a given occasion (provided he still performs as well as a reasonable doctor).
TYPES
CIVIL NEGLIGENCE
CRIMINAL NEGLIGENCE
CIVIL NEGLIGENCE
CRIMINAL NEGLIGENCE
GROSS CARELESSNESS
CIRCUMSTANTIAL EVIDENCE
CONTRIBUTORY NEGLIGENCE
Example such as not giving correct history to doctor, not following the instruction and advise of
doctor, failure to attend treatment at prescribed time, tampering with wound dressing/plaster etc.
ONUS OF PROOF:
Here the defendant (doctor) has to prove that plaintiff (patient) has contributed for the injury
because of want of care or wrong act.
VICARIOUS LIABILITY
For any negligent act of subordinate, the master or superior authority can be held responsible
“qui facet peralium , facet per se” he who acts through another, acts himself .
OBJECTIVES
Indian medical association vs VP Shantha 1995 (3) CPR 412: AIR 1996 SC 550: 1995 (3) CPJI: 1995 (6)
A doctor registered as medical practitioner and entitled to practice in homeopathy only, prescribed
an allopathic medicine to the patient. The patient died.
The doctor was held to be negligent and liable to compensate the wife of the deceased for the death
of her husband on the ground that the doctor who was entitled to practice in homeopathy only, was
under a statutory duty not to enter the field of any other system of medicine and since he trespassed
into a prohibited field and prescribed the allopathic medicine to the patient causing the death, his
conduct amounted to negligence per se actionable in civil law.
Subh Lata vs Christian Medical College (Punjab SCDRC OC No. 14 of 1994 decided on 15.6.1994; 1994
(2) CPR 691; 1995 (1) CPJ 365; 1995 CCJ 512.
The complainant alleged that her husband died due to the complications arising after kidney biopsy.
The State Commission held that the complainant had suppressed the crucial facts in her complaint.
Besides serious life threatening diseases, the deceased was already suffering from tuberculosis and
Staphylococcus aureus septicaemia (a serious infection of the blood by bacteria). These are very
serious diseases with a very high mortality rate especially when the heart, lung and brain get
infected.
Hence, the complainant had not come with clean hands and thus disentitled herself to relief under
this jurisdiction of the CP Act. Complaint dismissed with 1,500/ as costs.
Supreme Court of India Jacob Mathew vs State of Punjab and Anr on 5 August, 2005
Whenever a complaint is received against a doctor or hospital by the Consumer Forum (whether
District, State or National) or by the criminal court then before issuing notice to the doctor or
hospital the matter must be referred to a competent doctor or committee of doctors, and if prima
facie a case of medical negligence is established, only then the notice be issued The police officials
were warned not to arrest or harass doctors except as per the criteria laid down in Jacob Mathew
case, otherwise they will have to face legal action
LABOUR LAWS
The Occupational Safety, Health and Working Conditions Code (13 LAWS)
WAGE CODE
PAYMENT OF WAGES
CHAPTER III
Penalty
Minimum Wages
CHAPTER II
Framework to protect the rights of workers to make unions, reduce the friction between employers,
and workers and provide regulations for the settlement of industrial disputes.
EMPLOYEE’S COMPENSATION
CHAPTER VII
To compensate for loss in earnings due to accidents that occurred during the course of their
employment.
Death 50 %
Worked for at least eighty days within twelve months before her expected delivery.
26 Weeks
Paid leave
Partial withdrawals allowed for specific expenses such as house construction, higher education,
marriage, illness etc.
GRATUITY
It means gift
It shall be paid on termination after he has rendered service for a period not less than 5 years.