Digital Healthcare – Laws & Regulations in India

Digital health is using technologies to help improve individuals' health and wellness. These technologies include both hardware and software solutions and services, including telemedicine, web-based analysis, email, mobile phones and applications, text messages, wearable devices and clinic or remote monitoring sensors. Really it's about applying digital transformation, through disruptive technologies and cultural change, to the healthcare sector. Digital health is a multi-disciplinary domain involving many stakeholders, including clinicians, researchers and scientists with a wide range of expertise in healthcare, engineering, social sciences, public health, health economics and data management.

Digital Healthcare has been around in India since long but COVID-19 pandemic has put it in the spotlight and we are noticing mass adoption as 5 crore Indians accessed healthcare online in the last three months (Practo’s Insights Report, 18 Jun3 2020). In a significant move, the Ministry of Health and Family Welfare (“MoHFW”) on March 25, 2020, has issued the Telemedicine Practice Guidelines to provide healthcare using telemedicine and that is another major reason behind surge in online consultations. Also these Guidelines are one of the best guidelines ever published and the reason that telemedicine practice will stay in India. The Guidelines have made the practice of text/audio/video based medical care legal and regulated and thus have given platforms (mobile apps, web portals & social media) as well as doctors the standards to follow.

The legal and regulatory framework in India is/will be govern by following relevant acts / bills –

• Telemedicine Practice Guidelines by MCI & NITI Aayog, 2020
• Personal Data Protection Bill, 2019
• Information Technology Act, 2000 & Information Technology Rules 2011
• Clinical Establishment Act, 2010
• MCI Act, 1956 & MCI Regulations 2002
• Indian Medical Council Act, 1956 and Indian Medical Council Regulations 2002
• Drugs & Cosmetics Act, 1940 and Rules 1945
• Other Service Providers Regulations under the New Telecom Policy 1999

In September 2013, MoHFW notified the EHR Standards (Electronic Health Record Standards) for India.  Those standards were chosen from the best available & previously used standards applicable to International EHRs, keeping in view their suitability to and applicability in India.  Accordingly the EHR Standards 2016 document is notified and is placed herewith for adoption in IT systems by healthcare institutions and providers across the country.  The MoHFW facilitated its adoption by making available standards such as the Systematized Nomenclature of Medicine Clinical Terminology (SNOMED CT) free-for-use in India, as well as appointing the interim National Release Centre to handle the clinical terminology standard that is gaining widespread acceptance among healthcare IT stakeholder communities worldwide.

In addition, the MoHFW has proposed a new bill named DISHA (Digital Information Security in Healthcare Act) to govern data security in the healthcare sector.  The purpose of this Act will be to provide for electronic health data privacy, confidentiality, security and standardization.  The MoHFW, through the proposed DISHA, plans to set up a statutory body in the form of a national digital health authority for promoting and adopting: e-health standards; enforcing privacy and security measures for electronic health data; and regulating the storage and exchange of electronic health records.

One of the most immediate changes that health tech companies may need to be prepared for is the cost of compliance – with the Personal Data Protection (PDP) Bill 2019. As of the current interpretation of the text of the PDP Bill, 2019 (which effectively can get signed into law at any time) there is no period provided to affected companies to comply with the data protection measures in the Bill. The requirement of having a privacy-by-design system in place means that for a lot of companies the cost of compliance will go up as they would have to upgrade/overhaul their data protection systems and software. This change would be akin to the one experienced by European companies when they needed to comply with the General Data Protection Regulation (GDPR), but at least, in that case, there was a period prescribed within which companies were permitted to overhaul their security systems.

If any IT company or startup into Digital Healthcare plans to offer and add telemedicine/telehealth software to already existing software like healthcare CRMs, clinical software and patient management systems, have to incorporate all the relevant Acts & guidelines. It will not only help their clients but also will help companies because as per Telemedicine Practice Guidelines, technology platforms are obligated to ensure many instructions otherwise can be blacklisted.

Digital Health: Why Digital Health will become the new normal

During COVID-19 pandemic, terms like telehealth, telemedicine, remote-patient monitoring, virtual care and digital health are thrown around very commonly, though these terms have been around for years, but the recent situation is accelerating patient awareness and physician adoption of these technologies.

With a growing need for social isolation, healthcare organizations are actively seeking ways to provide health services to patients with both COVID-19 and other conditions remotely.

Start-up investing is not a new phenomenon in the financial world, but one sector, in particular, has seen a veritable boom in investors since the beginning of the COVID-19 pandemic. While many industries plummeted in the first quarter of the year, digital health companies closed the first quarter of 2020 with unprecedented levels of funding. Private equity and venture capital financing of digital health start-ups reached an all-time high of just over $3 billion in Q1 2020. 

Digital health seeks to enhance administrative tools, clinical tools and patient interaction to make the healthcare experience more effective, efficient, and positive for patients. Healthcare is far behind in technology, and this industry is looking to fill that gap. Those of us who work in the digital health space want to take current healthcare experience, which is something like Blockbuster Video in the early 2000s and turn it into Netflix.

The Board of Governors in supersession of the Medical Council of India (MCI) issued Telemedicine Practice Guidelines on March 25 to strengthen delivery in a post-Covid-19 world, with a focus on Health and Wellness Centres (HWCs) that provide preventive and primary healthcare within a 5 km radius at the grassroots level.

Telemedicine is being used by doctors to connect with patients, and by mid-level provider/health workers to connect patients with doctors without patients having to physically visit a hospital or clinic. Even post lockdown, it will help reduce the burden on the secondary hospitals and improve documentation, data-collection, diagnosis and care without risking the safety of the patients or the health workers. It is already being used with success in some states for reproductive and child health and tuberculosis notification and outreach.

There is a persistent shortage of doctors, health workers and hospital beds in the country, especially in rural areas and densely populated underserved states. India has 1.1 million allopathic doctors registered with the Board of Governors/State Medical Councils in December 2019, according to the National Health Profile 2019.

India’s public health expenditure is just 1.28% of its GDP, with the per capita public health expenditure being Rs 1,657 in 2017-18. The rising cost of treatment has led to inequities in access, with people in under-served rural areas and urban slums among the worst hit. For people living in rural areas completely dependent on government hospitals and clinics, the government allopathic doctor-patient ratio is 1:10,926, shows NHP 2019 data.

For a population of 1.36 billion, this makes the doctor-population ratio 1:1,457, which is lower than the WHO recommended norm of 1:1,000. In addition to doctors, India has a little more than two million registered nurses and midwives, many of whom need infection control training to care for patients with communicable diseases, such as Covid-19 and tuberculosis. The WHO estimates there is a deficit of 6 lakh doctors and 20 lakh nurses in India. Further, doctors often have to perform many routine tasks like data entry, patient management; pharmacy interfacing, ensuring the right gear and equipment are present in the required quantities at the point-of-need, and so on—over and above their medical and caregiving duties.

Before Telemedicine Practice Guidelines, there was no legislation or guidelines on the practice of telemedicine through video, phone, and online platforms, which include the web, apps, chats, etc. The existing provisions under the MCI Act, 1956, MCI Regulations 2002, Drugs & Cosmetics Act, 1940 and Rules 1945, Clinical Establishment Act, 2010, Information Technology Act, 2000 and the Information Technology Rules 2011 primarily governed only the practice of medicine and information technology.

With such a large rural population and insufficient trained medical staff and rural healthcare facilities, India can rapidly adopt telemedicine capabilities to make up for the gap. E-consultations, which took off during the lockdown, can vastly improve access to healthcare in rural areas. Mobile and internet penetration in rural areas is accelerating, and telehealth can piggyback on this trend. A quick e-consultation can determine whether the person has a simple problem or needs to access a facility for a physical check-up. We may find that 50-60% of cases could be diagnosed in this manner, and the remaining might have to travel for a consultation—largely reducing the healthcare burden in the country.