TATA INSTITUE OF SOCIAL SCIENCES,

SCHOOL OF HEALTH SYSTEMS STUDIES,

CENTRE FOR HOSPITAL MANAGEMENT,
Deonar, Mumbai.

Executive Post Graduate Diploma in Hospital Administration (EPGDHA)

Batch: 2019-2020

Document Title
HA5 ASSIGNMENT - I
Ethics, Governance and Legal Frame work
Submission Details
Name of the Student: Dr. BABU.J (PT)
Enrolment No.: 2019EPGDHA008

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CURRENT MEDICAL ETHICAL ISSUES

Current medical ethical issues faced in recent times are mainly balancing the quality and
safety of patient thereby gaining the confidence of patient and assurance of care.

The second issue is access of basic care to everyone, especially the economically weaker
section. With modernization and baby boomer generation continues, challenges are more to
manage chronic illnesses, coordination of care, and other services despite the shortage of
nursing staff and other healthcare professionals.

With organ transplant awareness and donar organs,there is a question of availability of

medications to meet the requirements in the future.

The other medical issues faced are patient privacy and confidentiality.

1. Patien’s Rights:
Healthcare provider or healthcare system should recognize the patient’s rights while
receiving medical care and respect their needs, especially about their choices. Patients
should receive a complete and thorough understanding about their health conditions and
need to be treated with dignity and respect. The Five Rights of Medication
Administation are the right patient, the right drug,the right dose, the right route, and the
right time.

2. Patient Privacy and Confidentiality:

Include security regulations including administrative, technical and physical
safeguards. Medical confidentiality is a set of rules that limits access to information
discussed between a person and their healthcare providers and kept private. Patient
control of access to their own data is needed for a number of reasons. It promotes data
exchange across healthcare systems to assure access to critical health data wherever the
patient may seek care. If the patients data is disclosed without prior authorization, it can
cause harm to the patient and he or she can take legal action against the provider for
breach of data, malpractice and breach of patient privacy and confidentiality.

3. Patient safety:
Aims to provide safety and preventing any injury or damage to them. The requirement
for honesty and openness in dealing with patients when things go wrong, and taking
responsibility. Preventable harms result in pain, suffering, and even death for patients
and lead to increased costs for medical systems. Patients safety concerns are now
regarded as a serious public health threat. The world Health Organisation (WHO)
Research Priority Setting Working Group states that “understanding the magnitude of
the problem and the main contributing factors that lead to patient harm is essential to

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devise effective and efficient solutions for different contexts and environments and to
build safer healthier systems.”

4. Conflict of Interests.
Conflict of interest is a situation in which a patient is or appears to be at risk of
acting in a biased way because of personal interests or influenced by a secondary
interest. The most important duty of doctors is to provide care that is in the best interests
of patients. For example, a physician’s relationship with pharmaceutical companies
(includes payments or gifts received from the companies) might affect how the report
results of research studies, what they teach medical students about particular drugs or
what treatment is recommended for a patient.

To facilitate this openness, multiple public reporting programs list payments and other
gifts that doctors have received from drug and medical device companies. Some medical
centers provide information on their websites about doctors’ conflicts of interest.
Patients can also ask doctors directly about their relationships withvarious entities.
Ultimately, doctors’ primary responsibilities are to patients, and clear discussions about
conflict of interest can help ensure that patients receive objective and unbiased care.

5. Ethics of privatization.
Increasing economic liberalization and privatization have affected health care as much
as they have affected many other social and administrative systems, perhaps even more
so. Though the changes are global, in India, the shift seems to have happened overnight,
and public health services have been overwhelmed all of a sudden. Due to privatization,
there has been a steep hike in consultations, diagnostics, laboratory tests, drugs and
hospitalization. In an pressure to make profit, some healthcare systems and diagnostics,
promote unwanted investigations to regain their investments. Due to privatization, the
economically weaker section suffer in a private sector. Privatization has also encouraged
unhealthy competition among the groups involved, since the objective is not only to
earn, but to earn more than others.

Privatization leads to the relative neglect of problems from which there is little to
earn. Everyone including the state is interested in setting up commercially viable units.
National preventive programmmes get neglected.

There is also an undue stress on procedure-oriented medicine. Well-considered,

comprehensive advice is bypassed for a computerized laboratory test, resulting in the
loss of the human touch.

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6. Informed consent.
Informed consent is a process of communication whereby a patient is enabled to make
an informed and voluntary decision about accepting or declining medical care. The
aspects of informed consent include ethical a course of action to promote decision
making, provide information, and avoid unethical forms of bias. Patients have the right
to refuse medical therapies, whether on religious or other grounds, if they are competent
to do so. Patient autonomy does allow for healthcare providers to educate the patient but
does not allow the healthcare provider to make the decision for the patient.

7. Dealing with opposite sex and relationship.

Much research on gender differences in medicine ha s students’ perceptions and
comfort levels regarding patients’ gender during consultation of their own gender, were
more intimate examinations upon the opposite gender. Sexual relationships between
medical practitioners and patients or between medical staff are strictly forbidden at a
healthcare facility, so the code of ethics should be explicit about.

8. Beginning and end of life:

In medical ethical issues are mainly about prognosis, dying, and end of life care
mainly withdrawing or withholding treatment based on informed consent or family’s
consent, physician assisted suicide or euthanasia. The ethical principles including
autonomy, beneficence, non malfeasance, justice and fidelity. Providers should have a
discussion about end of life care and use of a living will or power of attorney for
healthcare so that decision making can be maintained even if patient’s decision making
capacity has been lost. Sometimes palliative care should be started once diagnosis and
prognosis has been made. Medical futility “refers to interventions that are unlikely to
produce any significant benefit for the patient.

9. Transmission of Diseases:
The recent outbreak of a new virus called Ebola virus has been a major impact on the
right of healthcare providers to protect themselves from communicable disease both by
direct and indirect contact from an infected patient. Ethical and legal questions arise
when a patient’s health history is not provided to the medical staff.

10. Healthcare team ethics.

It is a multidisciplinary approach to autonomy, beneficence, non malfeasance and
justice. Ethical standards in medical care promote other important moral and social
values such as social responsibility, human rights, patient’s welfare, compliance with the
law, SMC’s regulations and patient’s safety.

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Therefore, Medical Ethics Problems can be Challenging. Medical ethics involves

examining a specific problem, usually a clinical case, and using values, facts, and logic
to decide what the best course of action should be. Doctors may deal with a great variety
of perplexing ethical problems even in a small medical practice. Some of them are:

 Withholding treatment to meet an organisation’s budget, or because of

insurance policies;
 Accepting money from pharmaceutical or device manufacturers;
 Upcoding to get treatment covered;
 Getting romantically involved with a patient or family member;
 Covering up a mistake;
 Reporting an impaired colleague;
 Cherry-picking patients;
 Prescribing a placebo;
 Practicing defensive medicine to avoid malpractice lawsuits;
 Dropping insurers; and
 Breaching patient confidentiality owing to a health risk.

Professional standards are a way to provide some guidance on ethical problems, but they
cannot address every issue, and they may not address troubling nuances, such as recounciling
two conflicting values.

Key Values for Deciding Ethical Issues

Many professional ethicists recommend using four basic values, or principles, to decide
ethical issues:

1. Autonomy: Patients basically have the right to determine their own healthcare.
2. Justice: Disturbing the benefits and burdens of care across society.
3. Beneficence: Doing good for the patient.
4. No malfeasance: Making sure you are not harming the patient

Some of the reasons to take medical ethics seriously are:

1. To help resolve disputes between family, patients, physicians, or other parties
2. To maintain a clear conscience.
3. To not make yourself look uninformed.
4. To maintain the respect of your patients.
5. To maintain respectful relationships with other clinicians.
6. To maintain some efficiency.
7. To reduce burnout.

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VIEW OF NEW CLINICAL ESTABLISHMENT ACT

Introduction:
The Clinical Establishments (Registration and Regulation) Act , 2010 has been
enacted by the Parliament of India for registration and regulation of all clinical
establishments in the country for standardized facilities and services provided by them. It is
an Act that requires all healthcare facilities to register themselves and provides standard
guidelines.

It requires the state governments to implement the law, though many states have not,
but the states have a choice of implementing the law in their respective states.

The goal of the Act is to register all the healthcare facilities to implement standard
practices. The clinical facility may either be a hospital, a maternity center, a clinic, a nursing
home, a polyclinic, a diagnostic center, a laboratory center or any other institution that offers
services to patients.

The Act also elaborates on the formation of a National Council including states and
union territory councils with a provisional registration for 1 year that must be renewed or to
be obtain a permanent registration. For running a unregistered establishment, there is a fine
that has to be paid. There is also fine for holding up on investigations, withholding
information or give false information. In case of violation by a corporate body, the
management shall be held responsible.

The draft notification on Clinical Establishment (Central Government) Third

Amendment Rules, 2019, has been put up on the website of the Health Ministry and
comments have been sought from stakeholders within 43 days.

According to the proposed guidelines, the facility should be developed and

maintained to provide safe and secure environment for patients, their families, staff and
visitors and should be located in a place having a clean environment and quite environment
and should comply with local regulations in force, if any, from time to time.

The healthcare facility should have the required space for carrying out basic functions
of the facility as detailed in the rules and regulations.

The facility should be well lighted, ventilated and clean with adequate water supply
and other necessary requirements. It should have a clear board or signage that exhibits the
name of the clinic in local language at the entrance or on the building of the clinic very clear
according to the draft modifications indicated.
Under the human resource the Human Resource classification, the suggested standards
delineate the general practitioner or the specialist or other expertise doctors as per the extent

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of the clinic or polyclinic, should be registered with the State for Central Medical Council of
India.
The services rendered by the medical professionals should be in accordance with their
qualification in their field, training and registration. In a clinic or polyclinic, support staff or
the hospital care team members must be available to meet the care treatment and service
needs of the patient. However, the number of support staff depends on the workload and
capacity of the service being provided by the clinical establishment.
These set of common minimum standards framed are applicable to a single practitioner or
more than one staff by a general physician, specialist doctor or a set of doctors who
themselves are providing services to the patients like dispensing of medicine, injections and
dressing.
The health ministry from time to time has been writing to states and union territories to put
into practice the Act indicating alleged malpractice including negligent professional
behaviour, improper or illegal quality of care and service, inadequacy of services,
unreasonably high amount charged and not following standard treatment protocols in health
facilities resulting not in low standards of treatment, patient safety concerns, but also
concerns about transparency and accountability in healthcare costs.
The clinical establishment act was been enacted by the Center to provide for registration and
regulation of all clinical establishments in the country with a view to authorize the slightest
standards of facilities and services provided by them.
The act is relevant to all types (both therapeutic and diagnostic types) of clinical
establishments in the public and private sectors.

According to the Act, standard treatment protocols and guidelines are defined for 227
diseases, including dengue, chikungunya and malaria.
A technical board is to be set up to decide on the charges for treatment of diseases and
procedures at the healthcare facilities including both public and private hospitals. Healthcare
facilities are supposed to display the charges for each procedure and facility and to keep the
patient informed in advance.

Summarization of clinical establishment act:

1. Registration of all healthcare professionals.
2. Regulation of all drugs and other commodities.
3. Standard protocol and care.
4. Transparency and accountability in healthcare costs.

The Act is applicable to all types, both therapeutic and diagnostic type of Clinical
Establishments from the public and private sectors, belonging to all recognized systems of
medicine, including single doctor clinics. The only special case is Clinical Establishments run
by the Armed forces.

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The Clinical Registration and Regulation Act are:

1. Central Council of Homepathy Act, 1973.

2. Clinical Establishments (Registration and Regulation) Act, 2010.

3. Dentist Act.

4. Drugs and Cosmetics Act, 1940.

5. Drugs and Magic Remedies (Objectionable Advertisements) Act, 2010.

6. HIV/AIDS Prevention Act.

7. Indian Medical Council Act.

8. Mental Health Act, 1987.

9. Narcotic Drugs and Psychotropic Substances Act, 1985.

10. Mental Health Care Act, 2017.

As per the report submitted by the Government of India, planning commission namely
“Clinical Establishments, Professional Services Regulation and Accreditation of Health Care
Infrastructure, these include promotion of legislation for health facilities and services, disease
control and medical care, human power (Education, Licensing and Professional
Responsibility), Ethics and Patients Rights, Pharmaceuticals and Medical Devices, Radiation
Protection, Poisons and Hazardous Substances, Occupational Health and Accident
Prevention, Elderly, Disabled and Rehabilitation Faculty, Women and Child Health,
Smoking/Tobacco Control, Social Security and Health Insurance, Environmental Protection,
Nutrition. Therefore, the report focuses the need for a central legislation for registration of
clinical establishments in the country and uniform standards need to be elaborated for the
entire country.

Objectives of the Act:

The Act makes it compulsory or mandatory for registration of all clinical
establishments both diagnostics and clinics across all recognized systems of the medicine

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both in the public and private sector except those run by the Defence forces. The registration
authority facilitates policy making, resource allocation and determines the standards of
treatment. I can impose fine or take disciplinary action for non-compliance of the provision
of the Act. The Act lays down Standard Treatment Guidelines for common disease
conditions, for which a Act lays down Standard Treatment Guidelines for common disease
conditions, for which a core committee of experts has been formed. Furthermore, the Act
makes all clinical establishments to provide medical care and treatment necessary to Act
makes all clinical establishments to provide medical care and treatment necessary to stabilize
any individual who comes or is brought to the clinical establishment in an emergency medical
condition, especially women in labor and accident emergencies.

Implementation of the Act

According to the notification dated 28 January, 2010 the Act came into force in four
states of India, 2010 the Act came into force in four states of India, particularly Arunachal
Pradesh, Himachal Pradesh, Mizoram, Sikkim and all Union Territories. Arunachal Pradesh,
Himachal Pradesh, Mizoram, Sikkim and all Union Territories. Later on, Uttar Pradesh,
Rajasthan and Jharkhand have supported the Act under Clause 1 of article 252 of the
Constitution. In 2013, Maharashtra planed a multi-stakeholder committee to formulate the
Maharashtra Clinical Establishment Act to a significant step towards standardization of
quality and costs in the private medical sector. The Kerala Clinical Establishments
(Registration, Accreditation and Regulation) Bill, 2009 is awaiting a go-ahead from the
Government to be implemented.

An overview of the Clinical Establishment (Registration and

Regulation) Act
Article 47 of the Constitution lays down the power upon the State for aiming at
improvement in public health as its primary duties, in particular the States shall attempt to
bring about prohibition of the consumption except for medicinal purposes of intoxicating
drinks and of drugs which are injurious to health.

Therefore, with the objective to strive at fulfill this responsibility, the Government of
India enacted the Act with the aim to provide for registration and regulation of clinical
establishments in India.

The Act defines “Clinical Establishment” and bring under the ambit of clinical
establishment all hospitals, maternity centers, nursing home, dispensary, clinic, etc, that
offers services and treatment in connection with the diagnosis or treatment. It also includes a
clinical establishment which is owned, controlled and managed by government, a trust, a

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corporation registered under a Central, Provincial or State Act, a local authority and a single
doctor.

The National Council for Clinical Establishment

The Act lays down establishment for a Council Body called the The National Council
for Clinical Establishment which is responsible primarily for setting up standards for ensuring
proper healthcare by the clinical establishment and develop the minimum standards and their
periodic review.

Clinical Establishments and procedure for registration of the

Clinical Establishment
Section 11 of the Act of the Act directs that no person shall run a clinic establishment
unless it has been duly registered in accordance with the provisions of the Act.

In September 2014, the Government of India, the Ministry of Health and Family
Welfare issued the Application format for Permanent Registration of Clinical Establishments
which requires the applicant to provide information such as, among others, establishment
details, types of service, systems of medicine, etc.

Minimum Standards to be followed by Clinical Establishments

Section 12 of the Act lays down that for registration and continuation of a Clinical
Establishment registration is a must, and at present minimum standards are only available for
medical diagnostic labs which were notified in May 2018.

Conclusion
To conclude with, India is already much better itself in the global strata of
pharmaceutical market. It is apparently an advantage above that for the fact that India is
expected to witness a huge improvement in its public health as the Government is showing an
avid approach towards striving at the objective of the Clinical Establishments (Registration
and Regulation) Act, 2010. With the accomplishment of the diligently drafted standards
through this Act, it is expected that in the coming years each and every clinical establishment
in India will be systematized and stringently compelled equipped with all the basic minimum
standard of medical care, therefore, the framework of healthcare section in India is expected
to grow through an enormously appreciable revolution.

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