India's Healthcare in Transition: The Need for Institution-Based Medico-Legal Guidelines

Abstract

India’s healthcare system is in transition that will likely be accelerated and redirected by the Covid-19. Today, the provider-recipient relationship in healthcare institutions goes far beyond the traditional physician-patient relationship. The providers include individuals, teams, departments, clinics, and hospitals; the individuals may be physicians, surgeons, residents, students, nurses, para-medicals, social workers, and others. The recipients include patients, their families, communities, caretakers, and others. The changing matrix of relationships between the providers and the recipients is at the core of the healthcare transition.
The medico-legal guidelines have not kept pace with the transition. Ideally, they must encompass the complex web of relationships between the providers and the recipients. They must define the responsibility, accountability, and autonomy of the providers to the recipients. To this end, the adoption of institution-specific and institution-wide evidence-based guidelines in healthcare institutions needs to be standardized to reduce institutional and geographical variations. Arguably, an evidence-based uniform guideline could improve quality of healthcare and reduce harm to patients.
In this context the healthcare institutions must formulate their own guidelines that are within the mandated laws, protect the providers of healthcare, and respect the requirements of the recipients of healthcare. The institutional guidelines must broadly align the purposes and processes of the institution’s staff and administration. They must help resolve the conflicts between guidelines from different levels of the government, professional bodies, and other stakeholders. They must also help interpret and translate the guidelines as they evolve, especially in crisis such as the Covid-19 pandemic. The institutions must exchange feedback and learn from each other to make uniform guidelines based on the type of institutions, their location, and other characteristics.
The guidelines must be systemic; their formulation, implementation, and evolution must be systematic. We will present: (a) a framework for institution-based medico-legal guidelines, (b) lessons from research and cases on the subject, (c) insights from a series of roundtables and webinars on the subject, and (d) a roadmap for future research, policies, and practices.

Full text

India’s Healthcare in Transition:
The Need for Institution-Based Medico-
Legal Guidelines
Dr Arkalgud Ramaprasad, Director, Ramaiah Public Policy Center (RPPC)
Professor Emeritus of Information and Decision Sciences, University of Illinois at Chicago
Dr Chetan Singai, Deputy Director, RPPC; Associate Professor, Ramaiah University of
Applied Sciences
Dr Anupama Sanjeev, Research Fellow, RPPC
Ms Devina Neogi, Research Associate, RPPC
November 8, 2020
Presented at the 28th Annual Karnataka Medico Legal Society Conference (KAMLSCON
2020)
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 1

Agenda
•Introduction
•Ramaiah Series on Medico-Legal Guidelines
•Making the ‘system’ visible
•Ontology of medico-legal guidelines for healthcare
•A systematic approach to formulating the guidelines
•Transitions in India’s healthcare
•Normative lags in India’s guidelines
•Need for institution-based guidelines
•Formulating institution-based guidelines
•Conclusion
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 2

Ramaiah Series on Medico-Legal Guidelines –
Rationale
•An intersection of healthcare and public policy
•An intersection of Ramaiah Medical College & Hospitals and Ramaiah
Public Policy Center
•A multidisciplinary opportunity to frame the issues and set the
agenda for research, policy, and practice
•A multi-stakeholder approach to frame the issues and set the agenda
for research, policy, and practice
•Physicians, dentists, academics, researchers, policy makers, regulators,
lawyers, judges, administrators, students, and others
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 3

Ramaiah Series on Medico-Legal Guidelines –
Events
•Ramaiah Roundtable on Medico-Legal Guidelines for Institution-
Based Healthcare in India –Saturday, May 25, 2019
•Ramaiah National Conference on Guidelines for Institutional
Healthcare Delivery in India –Friday, December 20, 2019. Sanjeev, A., &
Neogi, D. (2020). Report on Medico-Legal Recommendations. Ramaiah Public Policy Center.
https://doi.org/10.13140/RG.2.2.21871.87200
•Ramaiah Webinar on Medico-Legal Guidelines During Covid-19 –
Friday, July 17, 2020. Sanjeev, A., & Neogi, D. (2020). Report on the Ramaiah Webinar on Medico
Legal Guidelines During COVID-19. https://doi.org/10.13140/RG.2.2.28210.43204
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 4

Making the ‘system’ visible
For a systemic and systematic approach to medico-legal guidelines for institution-
based healthcare
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 5

Ontology of Medico-Legal Guidelines for
Healthcare – A Systemic View
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 6
Field Objective Provider Attribute Recipient Outcome
Medi cal Standards Individuals Responsible Patients Effective
Legal Compliance Physicians Transparent Families Appropriate
Ethical Non-Compliance Surgeons Accountable Communities Timely
Religious Compensation Residents Autonomous Caretakers Safe
Moral Penalty Students Others Efficient
Other Nurses Cost
Para-medicals Time
Others Personnel
Teams
Units
Multidisciplinary
Surgery
Others
Departments
Clinics
Hospitals
[to provide]
[healthcare to]
[for]
[outcomes]
Guidelines
Healthcare
[+]
[guidelines for]

©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 7
The ontology of medico-legal guidelines for institution-based
healthcare in India is a systemic map of the problem to: (a) design the
solution alternatives, (b) determine effective, ineffective, and
innovative alternatives, and (c) direct the choice through feedback and
learning.

Illustrative Systemic Requirements of Medico-
Legal Guidelines for Institution-Based Healthcare
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 8
Field Objective Provider Attribute Recipient Outcome
Medi cal Standards Individuals Responsible Patients Effective
Legal Compliance Physicians Transparent Families Appropriate
Ethi cal Non-Compliance Surgeons Accountable Communitie s Timely
Religious Compensation Residents Autonomous Caretakers Saf e
Moral Pe nalty Students Others Efficient
Other Nurses Cost
Para-me dicals Time
Others Personnel
Teams
Uni ts
Multidisciplinary
Surgery
Others
Departments
Clinics
Hospitals
[to provide]
[he althcare to]
[for]
[outcomes]
Guidelines
Healthcare
[+]
[guidelines for]
Illustrative Requirements (total = 5*5*14*4*3*4*5*6 = 5,04,000)
•Medical standards guidelines for individual physicians to provide responsible
healthcare patients for effective-appropriate outcomes.
•Legal compliance guidelines for team units to provide accountable healthcare
to families for efficient-cost outcomes.
•Medical non-compliance penalty guidelines for individual para-medicals to
provide autonomous healthcare to communities for effective-safe outcomes.
•Religious compliance guidelines for individuals-others to provide transparent
healthcare to patients for efficient-time outcomes.

A Systematic Approach to
Formulating the Guidelines
•Transitions in India’s healthcare
•Normative lags in India’s guidelines
•Need for institution-based guidelines
•Formulation of institution-based guidelines
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 9

Transitions in India’s Healthcare
•Transitions in recipients and outcomes
•Transitions in providers and attributes of care
•Transitions in field and objective of guidelines
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 10

Transitions in
Recipients and
Outcomes of Care
•Changing profile of recipients
•Individual patient to Multiple recipients
•Changing outcome expectations
•Simple to Complex
•Accepting to Questioning
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 11
Recipient Outcome
Patients Effective
Families Appropriate
Communities Timely
Caretakers Safe
Others Efficient
Cost
Time
Personnel
[healthcare to]
[for]
[outcomes]

Transitions in
Providers and
Attributes of Care
•Change in profile of providers
•Individual physician to Multiple providers
•Individuals to Teams to Institutions
•Change in profile of attributes
•Simple to Complex
•Trusting to Litigating
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 12
Provider Attribute
Individuals Responsible
Physicians Transparent
Surgeons Accountable
Residents Autonomous
Students
Nurses
Para-medicals
Others
Teams
Uni ts
Multidisciplinary
Surgery
Others
Departments
Clinics
Hospitals
[to provide]
[healthcare to]
Healthcare

Transitions in Field and
Objective of
Guidelines
•Change in profile of fields
•Integration and differentiation
•Convergence and conflict
•Change in profile of guidelines
•Retributive to rehabilitative to reformative to
restorative
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 13
Field Objective
Medi cal Standards
Legal Compliance
Ethical Non-Compliance
Religious Compensation
Moral Penalty
Other
Guidelines
[+]
[guidelines for]

Normative Lags in India’s
Guidelines
•Laws governing healthcare in India
•Laws governing medico-legal aspects
•Challenges in formulating the guidelines systematically
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 14

Laws Governing Healthcare in India
•Qualifications/Practice and Conduct of Professionals
•Storage/Sale of Drugs and Safe Medication
•Biomedical Research
•Management of Patients
•Medico Legal Aspects
•Patients, Public and Staff within the Hospital Premises and Environmental
Protection
•Employment of Manpower
•Professional Training and Research
•Business Aspects of Hospital
•Commissioning a Hospital
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 15

Laws Governing Medico-Legal Aspects
•Law of privileged communications
•Indian Evidence Act (disclosure of privileged / confidential patient related
information before a court of law –under protest)
•Law of Torts
•Consumer Protection Act -1986
•Protection of Human Rights Act
•IPC sections 52, 80, 89, 92, 93, 269 (Singh & Garg, 2013)
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 16

Challenges in
Formulating
the Guidelines
Systematically
1. How can the guidelines bridge the normative lags?
2. How should the design of guidelines consider the outcomes on different recipients?
3. How should the design of guidelines be customized to the different providers?
4. How should the design of guidelines consider their impact on the different attributes of
healthcare?
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 17
Field Objective Provider Attribute Recipient Outcome
Medi cal Standards Individuals Responsible Patients Effective
Legal Compliance Physicians Transparent Families Appropriate
Ethi cal Non-Compliance Surgeons Accountable Communities Timely
Religious Compensation Residents Autonomous Caretakers Safe
Moral Penalty Students Others Efficient
Other Nurses Cost
Para-medi cals Ti me
Others Personnel
Teams
Uni ts
Multidisciplinary
Surgery
Others
Departments
Clinics
Hospitals
[to provide]
[he althcare to]
[for]
[outcomes]
Guidelines
Healthcare
[+]
[guidelines for]

Need for Institution-Based
Guidelines
•Institutional issues heightened by Covid-19
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 18

Institutional Issues Heightened by Covid-19
•With a limited number of tests, who should be tested?
•What should be the cost of the test to the recipient?
•In the event of a positive test, who should be quarantined? An individual, the
family, the community, the locality, or the region?
•With a limited number of ventilators, who should be put on the ventilator?
•How should the wellbeing of the providers be protected? What should be the
policy on use/reuse of personal protective equipment (PPE)?
•How should the religious sentiments of the recipients be respected? During
care? After care? In case of deceased?
•Should untested drugs and treatments be permitted? Under what conditions?
•Under what conditions should extreme lifesaving measures be adopted for
patients? Or, not adopted?
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 19

Formulation of Institution-Based
Guidelines
•The ideal institutional guidelines –a systemic view
•The existent institutional guidelines
•A framework for institutional guidelines during Covid-19
•Bridging the gap between the ideal and the existent
•Role of healthcare institutions
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 20

The Ideal Institutional Guidelines – A Systemic
View
•Assure responsible, transparent, accountable, and autonomous care
of the recipients of healthcare
•Include the recipients -patients, their families, communities,
caretakers, and others
•Assist individuals, teams, departments, clinics, and hospitals within
the institution make decisions for effective and efficient outcomes
•Specify the medical-legal-ethical-religious-moral standards,
compliance requirements, and non-compliance measures
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 21

The Existent Institutional Guidelines
•Based on directives from external agencies –the centre, state, and
Indian Council of Medical Research (ICMR)
•Narrow focus, are incomplete, and are often conflicting
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 22

Framework for Institutional Guidelines During
Covid-19
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 23
Standards Compliance
Requirements
Non-
Compliance
Measures
Medical  
Legal  
Ethical
Religious
Moral
Table 1: Emergent guidelines that were discussed
Standards Compliance
Requirements
Non-
Compliance
Measures
Medical   
Legal   
Ethical   
Religious   
Moral   
Table 2: Guidelines that must be addressed

Bridging the Gap Between the Ideal and the
Existent
•Re-orient existing individual guidelines towards the institution
•Formulate the standards, along with explicitly stated compliance procedures and
non-compliance consequences for the individual, team, and institutional provider
levels
•Balance the positive and negative effects they may have on the desired attributes of
healthcare
•Balance the desirable and undesirable outcomes for the recipients of healthcare
•Protect the providers of healthcare
•Define intra-department flow of control
•Forge inter-institutional alliances –move away from functioning in silos
•Define the role and responsibility for the recipient -a well-informed
patient, and family who will be active participants in healthcare-based
decision making
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 24

Role of Healthcare Institutions
•An internal committee to systematize and assess existing, and
formulate additional guidelines
•An inter-institutional group to communicate the guidelines and
coordinate them with the professional bodies and the government
•A collaborative program with academia to develop a knowledge base,
research, publication, and education on the subject
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 25

Conclusion
•India’s healthcare is being transformed
•Healthcare institutions must formulate medico-legal guidelines that
is:
•Systemic and not siloed
•Systematic and not ad-hoc
•Evidence-based >> Expertise-based >> Experience-based
•Adaptive and incorporates feedback and learning
©Ramaiah Public Policy Center KAMLSCON Webinar_2020_11_08 26