Legal Framework for Retail Business

Retail Business Laws: A critical Analysis of

Health care sector

Submitted by –

Shreya Kumar
21RM954

Submitted to –

Dr. Navin Shrivastava

 Abstract
The Indian healthcare market is thriving as a result of advancements and more efficient
healthcare delivery. Different governmental initiatives, including Smart Cities, Tidy India,
Digital India, and Ayushman Bharat, to identify a few, are generating a supportive framework
that is boosting service sectors such as interaction, healthcare, the surroundings, technology,
energy, and banking. A large ageing population, health care costs in the Western w0rld, an
increase in chronic and disease transmission, and an increasing disposable income, which
helps to make health - care services more affordable, are all demand drivers.

It is advantageous to have access to world-class hospitals and skilled medical professionals.

Major surgery in India costs approximately 10% of what it does in most developed countries.
Healthcare compliance requires the creation of effective processes, policies, and processes to
define appropriate behaviour, train staff, and then weekly update to the processes,
regulations, and procedures. Prioritize quality - Quality of care is becoming increasingly
important as clients begin to exercise their right to choose how and with whom they receive
healthcare. They want data and process transparency. As a result, health systems will need to
concentrate on how to publish quality outcomes in a way that is meaningful to patients.
Patient safety is a top priority for patient advocacy groups and healthcare leaders.

Those who will conduct more comprehensive investigations than ever before into medical
error, hospital-acquired diseases, wrong-site surgery, and pressure ulcers. NABH (part of the
Quality Council of India) is now tracking clinical and managerial markers at the clinic, state,
and federal levels. In India, healthcare is provided through a universal healthcare system that
is managed by the component states and territories.
 Introduction
India has made significant leaps in the delivering of health services over the last few
centuries. It is one of the most important industries in terms of employment and revenue, and
it is rapidly expanding. The majority of Indian healthcare is provided by either public or
private providers. The main goal of public health coverage is to provide quality care through
community-level health programmes in order to reduce mortality and morbidity from various
communicable and noncommunicable diseases. It employs a tiered network infrastructure in
which primary care is provided through semi and primary health centres, whereas secondary
and tertiary care is provided at better equipped institutions such as community health centres,
district hospitals, and medical colleges, which are mostly located at head office.

The private sector is mainly concentrated in tier I and tier II parts of the city. The
discrepancies and challenges to equitable, available, and elevated healthcare become clear
when discrepancies and obstacles are compared geographically. Over the decades, the
National Health Policies have played an important role in guiding the country's strategy to a
more inclusive health service, with the goal of gradually accomplishing Universal Health
Coverage (UHC).
 Background
Clinicians have always set their own quality of care, and their behaviour have always been
allowed to judge by trying to compare them to those of other physician. Rather than patients
and colleagues, the large percentage of ethical canons, or norms, highlighted professional
etiquette and cordiality toward colleagues. The legal landscape is changing since the 1960s.
For several physicians, civil lawsuits alleging medical negligence have become a way of life.
Abortion and the cessation of medical treatment, which were once considered ethical issues,
now have emerged as important civil rights issues in courthouses around the world, along
with questions of consent form and clients' rights.

The judicial power has been implicated in security and privacy issues, confidentiality,
required vaccination, and research participants research in wide-ranging activity to help at
halting the transmission of contagious diseases such as acquired immunodeficiency syndrome
(AIDS) & influenza. Since the September 11, 2001 attacks on the USA, doctors have been
involved in the preparation for possible bioterrorist incidents targeting infectious diseases
such as smallpox. A botched attempt to vaccinate all urgent health care providers against
smallpox was among these planning and preparation, as were much more successful
initiatives to engage state and local public health officials in disaster response planning.

The final steps included evaluations of the sufficiency of public health care law, which is
primarily state law. The change has been so profound that forensic treatment is now classed
as a subfield of health law, highlighting its significance to both medicine and health care in
overall. This emerging field of health law is involved in legislators, government regulators,
hospitals, and doctors offices, in furthermore to the courts.
 COVID-19's Impact on the Indian Healthcare Sector
The COVID-19 global epidemic has naturally rattled the groundwork of India's healthcare
system, as it has evaluated even the most advanced healthcare systems worldwide. The
overall reaction to the pandemic saw collaboration between the government and industry.
Private Indian health providers stepped up to provide all of the aid that the state demands,
such as checking, separation beds for treatment, employees, and equipment at govt COVID-
19 hospitals & home care.

In our country India, the private sector has contributed significantly, accounting for
approximately sixty % of hospitalisation. Most private clinics began their proposals in
response to the COVID-19 global epidemic, which also included huge investments in
preparing facilities for infection prevention and control, and also building the infrastructure
for isolation and therapeutic interventions, as well as outfitting the clinic with proper medical
supplies and extra workforce. Moreover, as a result of postponed health tourism and elective
surgeries, healthcare facilities and labs have seen a significant decline in income (the global
epidemic is thought to decrease private hospitals' operating profit by approximately forty %
this fiscal-year. As per the govt advise, outpatient departments (OPDs) were also shut for
almost the whole year.

The health sector established a strong action plan to battle the pandemic, which included the
development of dedicated COVID-19 hospitals, isolating centres, plus technology enabled
resource mapping, in partnership with the federal and the state govts. The Indian govt used
tech and built a variety of applications at both the state and national levels to successfully
manage the outbreak. The Aarogya Setu smartphone app is widely utilised across the nation
to aid with syndromic mapping, c0ntact tracing, & self evaluation. Response management,
which comprised critical item distribution in confinement zones, tele consultations with
sufferers, room management, and real time review and monitoring by authority, was
supplemented by such technological platforms.

Investments in the Indian healthcare sector

Despite certain setbacks, India's healthcare system proved resilient during the pandemic.
India has positioned itself as a global leader in the manufacturing of hospital devices,
disposables, pharmaceuticals, and, most recently, vaccinations. India not only satisfied its
own demands, but also stepped up to assist other countries. As a result, the healthcare
industry appears to be a good place to invest. The following are a few elements that are
promoting future investment and growth -

 Medical facilities in Tier II & III cities - Shortfalls in critical infrastructure, such as

the requisite number of beds or availability of advanced equipment, were highlighted
during the pandemic's terrible times, highlighting the need for a health service that is
'emergency-proof' in the long term. Medical chains and specialist centres, particularly
in Tier II & III cities, are moving forward to boost capacity. Several hospital chains
have begun to develop in these cities by opening modest clinics and forming
partnerships with prominent drs. It is also in accordance with the govt's aim to
improve the no. of hospital rooms per 1,000 people and close the accessibility gap,
especially in the country's rural and sub-urban regions.
 Health insurance knowledge - In recent times, there's been a major source of health
life insurance consciousness, and with each each year, more individuals are engaging
in medical insurance.
 Government policies - having being planned in advance of the pandemic, the
government's attempts to provide universal health coverage under 'Health for All,' as
well as programmes like Ayushman Bharat and the National Digital Health Mission,
have increased dramatically. Private actors can grow their reach and presence as a
result of these initiatives to make healthcare more inexpensive and accessible to the
general people.
 Medical tourism - Foreign visitors are attracted to India's healthcare industry because
of the access to high services at lesser prices than in Western Europe or the USA.
Bangladesh seemed to have the largest percentage of medical FTAs (foreign tourist
arrivals) in 2012, with twenty two %, trailed by the Maldives, Afghanistan, and Iraq,
with 17 %, 9 %, and 8 %, respectively.
 Technological use - Internet consultations and technology platforms are in high
demand, especially in today's world. In August 2019, the Ministry of Health and
Family Welfare unveiled the "e-Sanjeevani app", which is an integrated web-based
telemedicine system. Its purpose is to close the gap between urban & rural India in
terms of healthcare.
 Critical overview of the sector
Compliance & License Requirements for Indian Healthcare Companies

As a watchdog, the Ministry of Health and Family Welfare supervises India's healthcare
business. The Directorate General of Health Services (DGHS) provides technical guidance on
all medical and public health matters, as well as being involved in the delivery of various
health services. The pharmaceutical sector is one of the areas governed by healthcare
regulations, and it is tightly regulated by the following:
 Central Drugs Standard Control Organization (CDSCO)
 National Pharmaceutical Pricing Authority (NPPA)
 Indian Council for MedicalResearch (ICMR)
 Drugs Controller General of India (DCGI)

Hospital Commissioning Laws - legislation that make sure that hospital amenities are built
after a thorough registration process, that they are secure for the public for using, that they
have the minimum necessary of infrastructure for the type and quantity of workload expected,
and that they are subject to regular testing to ensure compliance.

Storage, Drugs Sales & Safe Medication Regulations - laws that control the use of drug,
chemical, blood, and blood product, prohibit the misuse of harmful drugs, control drug sales
through licensing, prevent drug adulteration, and impose penalties on violators.

Patient Management Laws - laws that set standards and norms for medical professional
conduct, restrict or ban the performance of specific treatments, prevent abusive practices, and
influence public health problems/epidemic disease. They deal with emergency situations,
medicolegal matters, and all that goes along with them, including death certificates,
autopsies, and various sorts of professional malpractice.

Environmental safety regulations - strive to safeguard the environment by prohibiting

contamination of the air, water, surfaces, & noise, as well as punishing violators.

Any hospital's administrator should be informed of the licences that are absolutely necessary

and update them as required. Reports & Returns on a Regular Basis.  He should be informed
of the reports and returns that are generally expected by different agencies on a routine basis
as a legal duty.

There are surprisingly few health legislations in relation to the size & complexity of the
health-care industry. In order to link the overall health-care sector with the aims described in
India's numerous policies, a comprehensive health-care act must be written. Noncompliance
with these norms and regulations causes the bulk of regular medicolegal issues. A hospital or
doctor will be on the right side of the law if they are well-versed in such laws and regulations
and properly follow them.
 Legal know how of business

Significance of an arbitration clause in healthcare industry

Patients and health-care employees have long had a tense relationship, but it grew
considerably throughout the 1970s as allegations of misconduct in the medical industry
skyrocketed. A considerable increase in the field of medical care has recently occurred,
resulting in the implementation of novel sets of decisions and decision makers for the
provision of critical facilities and health care. Medical care today allows patients choose the
most appropriate care programme, as well as reimbursement schedules and access to the best
and most skilled specialists.

The presence of a wide collection of decision makers, and an increase in the control system,
has increased the possibility of a disagreement dramatically.
Medical care providers and health insurance are resorting to alternative forms of dispute
resolution to lessen the repercussions of escalating disputes, according to unofficial sources
and evidence. Private & legally binding arbitration agreements are one of them. Binding
arbitration that is required by law is a contentious practise. According to the findings, this
practise is extremely advantageous because it leads to more informed decisions and the
maintenance of positive connections between doctors and patients or medical personnel.

Disagreements have plagued the healthcare profession in recent years –

 Conflicts between members of medical associations or between hospitals and other

employees.
 False Claims Act (FCA) and other types of fraud cases involving clinics, physicians,
pharmacies, drug companies, and other entities.
 Mergers and acquisitions-related disputes.
 Govt agencies, pharmacists, doctors, and physicians are all involved in reimbursement
conflicts.
 There is a lot of debate about risk management & personal accident insurance.

The current healthcare crisis is a topic of discussion in various nations, including India. These
ramifications could be felt all through the system as well as the economy in general. These
legal fees are passed on to patients, leading to an increase in patient dissatisfaction in the
healthcare profession. This is where "Alternative Dispute Resolution," a low-cost, fast-
moving lawsuit option, comes into play. To combat escalating legal expenses, a variety of
healthcare providers and insurers are resorting to Alternative Dispute Resolution (ADR)
techniques, including mediation and arbitration. Providers and insurers agree to address
future conflicts through these procedures or through litigation along with a pre-dispute
arbitration and mediation clause in health admission contractual agreements.
Non-disclosure Agreement in healthcare industry

A non-disclosure agreement for a clinical practice protects clients' personal and medical data
against unethical and professional release. A non-disclosure agreement for a medical practise
safeguards patients' personal and medical information obtained during treatment or study
from unethical & professional disclosure. Volunteers & workers of hospitals, clinics, and
other medical practises who have access to the data must sign a confidentiality clause that
legally binds them to keep it secret.

Medical Research Confidentiality Agreement - Although most individuals are aware of the
concept of secrecy in terms of individual patient care, it is equally critical in medical
research. While studies provide medical experts with access to research participants' personal
information, incorrect disclosure of that information can be fatal for the project. Professionals
involved in research sign a clinical research confidentiality clause to avoid this from
occurring.

Medical Facility Confidentiality Agreement - A non-disclosure agreement could be used to

prevent private information from being leaked out when a medical organization is set to
unveil a new facility. This helps to prevent company transactions from making it public
before they have received the essential regulatory clearances. Those working on the project
may be requested to sign a medical office privacy agreement to keep the plans hidden.

Medical Procedure Confidentiality Agreement- Various techniques are utilised to address

various medical issues. While most individuals are aware that chemotherapy is being used to
fight cancer, the average individual with no medical expertise is unlikely to comprehend how
the treatments are delivered. A procedure confidentiality clause may be required of doctors
and other healthcare practitioners who work with patients undergoing these procedures.

HIPAA Nondisclosure Agreement - Only healthcare staff and professionals are covered by
a HIPAA nondisclosure agreement. This document mentions the Health Insurance Portability
and Accountability Act, also known as Public Law 104-191. This law defines the standards
for medical employees who deal with electronic health information, such as health insurers,
clinics, and other health professionals.

Patient medical data, financial data, billing records, or any individually identifiable health
information are all considered health information under HIPAA. Employers who are subject
to HIPAA should need their employees to sign a nondisclosure agreement to indicate that
they understand the legislation. Employees must understand the restrictions on sharing patient
data, as well as the significance of demonstrating due diligence.

Parts of a Nondisclosure Agreement

A conventional non-disclosure agreement has certain common components, but it can be
customised to the facility's tastes and needs. The portions of the agreement make it obvious to
people signing it what they are pledging to keep private. Because the agreement is lawfully
enforceable in the courts of law, this is crucial.

All such contracts should include clauses to –

• Protect the privacy of patients.
• Maintain the secrecy of any study undertaken at the site.
• Hold off on announcing plans for new facilities or services until all legal criteria have been
satisfied.
• Maintain the privacy of medical procedure information.
• Explain the consequences of breaking the nondisclosure agreement.

The best method to guarantee that the non-disclosure contract is as solid as possible is to get
the advice of a medical &/or legal expert. Make sure you include all of the data you want to
keep private. You are not need to include any information that you do not want the signing
party to see.
Boilerplate in HIPAA Nondisclosure Agreements - HIPAA non-disclosure agreements
contain some basic terms known as boilerplate. They are frequently found close to the end of
a document and consist of the following -

• A disclosure of any additional relationships not explicitly included in the agreement.

• A severability clause, which states that if one element of the agreement is found to be
incorrect, it does not invalidate the entire agreement.
• A clause declaring that the document's signed version is the final version and that no party
can rely on prior assertions.
• A waiver that protects the parties' rights to make a complaint about just a breach of the
agreement later, even if a long time has passed since the claimed breach.
• Injunctive remedy, which allows a court to order someone to do or stop from doing
something that would violate the agreement.
• A breakdown of legal fees and expenditures.
• The agreement's legal framework will be determined by which state's laws will apply.
• A determination of the institution to which any lawsuit related to the agreement will be
brought.
 Way Forward

Increased healthcare awareness, rising affluence, increased access to insurance, and lifestyle-
related disorders are predicted to drive India's healthcare market to USD372 billion by 2022.
By 2025, the Indian government wants healthcare spending to reach 2.5 percent of GDP
(gross domestic product). The COVID-19 epidemic has also shifted the government's and
business sector's plans for healthcare reform. Tele-medicine services have gotten a lot of
attention recently, and the government has published new guidelines to make them lawful in
India.

In conjunction with NITI Aayog, the Ministry of Health and Family Welfare (MoH&FW) has
announced new guidelines permitting registered medical practitioners (RMPs) to do is
provide healthcare services via tele-medicine. In response, the govt has launched the NDHM
to tackle the country's health crisis (National Digital Health Mission). This mission includes
tele-medicine, healthcare IDs, health data, e-pharmacy, & digi-doctor services.

The biggest health catastrophes of our time have highlighted not only the myriad obstacles
and deficiencies in our healthcare system, but also the significance of engaging in 'well-being'
on a personal and systemic level. It has ushered in a new era of digital and technology
advances and advancements that will help communities address those needs at a far faster
rate.
 Challenges Ahead
COVID-19's rising prevalence has prompted a plethora of challenging medico-legal issues.
Some of these difficulties are related to medical liability and malpractice, while others are
related to medical ethics and the physician-patient relationship.
In addition, India has been battling the pandemic in the lack of a well-established public
health law. To deal with the problem, the Indian Penal Code of 1860, the 123 years old
Epidemic Diseases Act, and the more contemporary Disaster Management Act of 2005 were
all invoked. Aside from this, the government has published a myriad of notifications,
recommendations, regulations, and rules connected to COVID-19.

It is hard for health providers to be informed of all of these laws & rights as India's healthcare
industry is among the most scrutinised, with several rules regulating it. The government and
private sectors are stepping up efforts to safeguard doctors from bogus lawsuits and to
educate them about their rights. Medical law is changing in numerous ways. A lack of
supportive health legislation hampered legal preparedness for a pandemic, but those that did
exist are unfamiliar to medical practitioners.

As a response, doctors must be educated on various medico-legal aspects of their practise, as

well as take steps to address developing medico-legal difficulties in the COVID age, such as
the younger breed of pandemic-driven regulations. Doctors should also have access to
resources that make it easier for them to learn about the regulations that support healthcare
care & their rights.
 Conclusion
Thanks to modern technologies and more effective service delivery, India's healthcare
business is booming. Smart Cities, Clean India, Digital India, and Ayushman Bharat, to
mention a few, are providing an enabling environment that is increasing service sectors
including communications, health-care, environmental, technology, power, and banking. A
large older population, increasing medical expenditures in the Western world, an increasing
prevalence of chronic and disease transmission, and a rise in disposable income all contribute
to the affordability of health care.

A bonus is the availability of world-class clinics and trained medical personnel. Major
surgery treatment in India costs roughly 10 % of what it does in most wealthy nations. To
define proper behavior, teach the firm's staff, and then weekly update to the processes, rules,
and procedures, health-care compliance necessitates the development of more effective
processes, policies, and procedures. Prioritize quality - The quality of care is becoming
increasingly crucial as patients start to exercise the right to choose where and with whom
they get healthcare. They want data and procedural transparency.
As a result, healthcare organisations will need to concentrate on how to communicate quality
outcomes to patients in a relevant way. Patient safety is a top priority for patient advocacy
groups and healthcare executives. They'll look into drug errors, hospital-acquired illnesses,
wrong-site surgeries, and pressure ulcers in greater depth than ever before. The National
Accreditation Board for Hospitals (NABH) is presently monitoring clinical and management
indicators at the hospital, state, and national levels, under the auspices of the Quality Council
of India. In India, healthcare is delivered through a national health-care system overseen by
the country's states and territories.

The biggest health crises of our time have highlighted not only the myriad obstacles and
deficiencies in our health-care system, but also the significance of investing in 'well-being' on
a personal and systemic level. It has ushered in a new era of digital and technology advances
and advancements that will help communities address those needs at a far faster rate.
 References

 India’s healthcare sector transformation in the post-COVID-19 era. (2021a, February 1).
KPMG. https://home.kpmg/in/en/home/insights/2021/02/india-healthcare-sector-
transformation-in-the-post-covid-19-era.html#:%7E:text=The%20COVID
%2D19%20pandemic%20has,a%20legal%20practice%20in%20India.

 https://industry.siliconindia.com/viewpoint/in-my-opinion/healthcare-compliances-in-india-
a-brief-overview-nwid-15128.html

 https://viamediationcentre.org/readnews/NDky/Arbitration-and-Health-Care-Disputes

 Law, O. S. P. U. |. Z. U. T. S. (2020a, May 17). Arbitration in the Indian Healthcare Industry.

JURIST - Commentary - Legal News & Commentary.
https://www.jurist.org/commentary/2020/05/yug-sinha-healthcare-arbitration/

 https://www.upcounsel.com/non-disclosure-agreement-for-medical-office#health-
insurance-portability-and-accountability-act-hipaa-nondisclosure-agreement

 G. (2021a, June 22). Indian pharma market: Emerging medico-legal issues in COVID era. The
Financial Express. https://www.financialexpress.com/lifestyle/health/indian-pharma-
market-emerging-medico-legal-issues-in-covid-era/2276151/