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.

Information Age Healthcare - The need of hour for India

In India as well as countries around the globe, the cost of taking care of people continues to rise every year. At the same time that the world’s population is aging, chronic diseases like asthma, diabetes, heart disease and obesity are increasing at rapid pace in every age group. In addition to this shrinking workforce and shortage of doctors and nurses (India: is currently running short of at least 600,000 doctors and 1 million nurses), along with the fact that fewer young medical professionals are training to replace them.

Combine all this with legacy hospital infrastructure and technology, paper-intensive record-keeping, and inconsistent standards, and there is no doubt that the situation calls for a smarter, more effective approach to healthcare.  This is also critical because a robust healthcare system is the hallmark of organized development. Healthy citizens will translate into a productive workforce and a thriving economy.

By definition this is a holistic approach to healthcare that integrates the best of technologies to remove information barriers, enabling data to be analyzed and shared in real time. Smart healthcare is about forging time and creating cost-saving collaborative partnerships among doctors, administrators, insurers, and healthcare institutions. It is about integrating communications into a single, consolidated infrastructure, and giving communities and individuals the tools and knowledge they need in order to make more informed choices. Such digital healthcare delivery systems powered by the Network can significantly improve operational efficiency, optimize collaboration, and lead to better patient care and outcomes.

A comprehensive solution that integrates real-time voice and video, clinical collaboration, patient and asset tracking, electronic medical records and nurse call information allows hospitals and healthcare professionals to spend more time with patients and less time on administrative tasks. Smart healthcare solutions can help improve both care delivery and business operations for hospitals and medical professionals by:

• Providing essential information to doctors and staff, regardless of the devices used
• Giving real-time access to patient records, images and expert consultations 
• Accurate tracking and location of patients, staff, equipment and medical supplies 
• Education programs for medical staff and patients

These solutions take full advantage of the limitless possibilities of Telehealth. IP video technology can link patients and providers to specialists and primary care professionals, paving the way to faster and more cost-effective remote medical consultations, patient diagnosis, and chronic disease management.

In countries like India, critical investments are needed in healthcare (remote health, elderly care), health information exchange, and telehealth. Evidence strongly suggests that implementing Information and Communications Technologies (ICT) can result in higher quality and safer, more patient-responsive healthcare. Mobile collaboration technologies and BYOD for example can be useful in delivery of better health outcomes.

In summary therefore, adoption of technology enabled solutions complimented with an array of healthcare management services, will help the healthcare industry in India leapfrog into 'Information Age Healthcare', much quicker than imagined before.

Online Healthcare in 2015 & Beyond

There are all kinds of facts, figures, and guesses floating around right now as to what will be the top healthcare challenges and trends in 2015 and beyond. The Indian healthcare sector alone is estimated to touch $160 billion in 2017 – roughly double from what it was in 2012 (according to a report by Equentis Capitals) resulting in the CAGR growth rate of about 15%. There are a bunch of factors such as easier access to good healthcare services, relative increase in incomes and more emphasis on health awareness all contributing to this growth. Not just this, there is a significant demand in the quality of healthcare services in Tier-II and Tier-III cities which means people are recognizing the need for specialty-care.

India’s obvious advantage is the large pool of medical professionals and the dramatically lower medical costs as compared to other Asian and western countries. The surgeries reportedly cost one-tenth of that in US or Europe, making it a lucrative location for medical tourism and even R&D. Other than being widely known to be an English speaking country, alternative techniques like Homeopathy, Ayurveda, Yoga and Unani make it stand out when compared to other competing south-east Asian and middle-eastern countries.

Technology will be a game changer in the manner in which healthcare services will be delivered in India. The private sector will be the major driving force behind technology adoption in the Indian healthcare segment. To optimize costs and effectively manage operations, IT solutions will become an integral part of process management, patient care and the Management Information System (MIS) in hospitals. With the health insurance sector poised for major growth in the coming decade, increasing demand from this sector for more efficient systems for storage and retrieval of information will put pressure on hospitals and other healthcare providers to imbibe technology to modernize existing infrastructure.

The convergence of healthcare with upcoming technologies such as Cloud Computing and wireless technologies will play a key role in improving accessibility and meeting the challenge of manpower shortage. The coming years are expected to witness greater deployment of tools such as Telemedicine, Teleradiology, Hospital Information Systems (HIS)/Hospital Management Information Systems (HMIS), online or Electronic Medical Records (EMR), etc.

It is estimated that there will be over 550 million internet users in 2018. 
In India, there will be an estimated 200M smartphone users by 2016.

Online healthcare has increased communication among various people. It is not only making doctors and hospitals more accessible to patients, it is also helping patients connect with other patients. People want to read real stories not just to be informed, but to be inspired. Furthermore, it is assisting people to learn more about their bodies and give all kinds of health information to potential patients- making them aware of treatment options and preventive measures.

Doctors are connecting with other doctors across the world. This global shift in digital healthcare is making it possible for people to receive more personalized and precise medicine and health services – reducing errors and cost, in turn, improving quality and providing easier access to medical facilities.

Challenges

India is home to a majority of people who are referred to doctors by family and relatives or by word-of-mouth. Making people believe that their health issues can be handled through the internet is a real problem. Building trust among these people can spell great success for healthcare portals.

Another point to note is that there are several healthcare start-ups focusing solely on ‘booking appointments’, and not many players in the hospitalization space. In India, the domestic hospitalization industry is a total of $280 billion (according to a McKinsey report), while the international hospitalization industry is indicated to be about $4 + billion (according to a report by Ministry of Health/KPMG 2014). This means, massive business for start-ups like Credihealth, who are adopting hospitalization as their forté.

Technology & Medicine

The most significant announcement that Apple made in 2014 wasn’t a larger-sized iPhone. It was that Apple is entering the health-care industry. With HealthKit, it is building an iTunes-like platform for health; Apple Watch is its first medical device. Apple is, however, two steps behind Google, IBM, and hundreds of startups. They realized much earlier that medicine is becoming an information technology and that the trillion-dollar health-care market is ripe for disruption.



2015 will be the year in which tech takes baby steps in transforming medicine. The technologies that make this possible are advancing at exponential rates; their power and performance are increasing dramatically even as their prices fall and footprints shrink. The big leaps will start to happen at around the end of this decade.


The health devices that companies such as Apple, Microsoft, and Samsung are developing are based on MEMS sensors, which are one of the exponential technologies. These enable the measurement of things such as heart rate, temperature, blood pressure, and activity levels and can feed data into cloud-based platforms such as HealthKit. They will be packaged in watches, Band-Aids, clothing—and contact lenses. Yes, Google announced in January that it is developing a contact lens that can measure glucose levels in a person’s tears and transmit these data via an antenna thinner than a human hair. In July, it said that it was licensing the technology to Novartis, enabling it to market it to people with diabetes. We will soon have sensors that monitor almost every aspect of our body’s functioning, inside and out.

Advances in Microfluidics are making possible the types of comprehensive, inexpensive diagnostics that in a single drop of blood, it can test for things such as cancer, cholesterol, and cocaine. Newer technologies coming from Nano biophysics like Gene-Radar, a portable nanotechnology platform that uses biological nanomachines to rapidly and accurately detect the genetic fingerprints of organisms. It will enable the detection of diseases such as HIV and Ebola and deliver the results to a mobile device within minutes—for a hundredth of the cost of conventional tests. By combining these data with EMR (Electronic Medical Records) and the activity and lifestyle information that our smartphones observe, Artificial Intelligence-based systems will monitor us on a 24 x 7 basis. They will warn us when we are about to get sick and advise us on what medications we should take and how we should improve our lifestyle and habits. 

With the added sensors and the apps that tech companies will build, our smartphone will become a medical device akin to the Star Trek tricorder. With health data from millions of patients, technology companies will be able to take on and transform the pharmaceutical industry—which works on limited clinical-trial data and sometimes chooses to ignore information that does not suit it. These data can be used to accurately analyze what medications patients have taken, to determine which of them truly had a positive effect; which simply created adverse reactions and new ailments; and which did both.


And then there is the genomics revolution. The cost of sequencing a human genome has fallen from $100 million in 2001 to about $1000 today and will likely cost as much as a blood test by the end of this decade. What this means is that the bits and bytes that make up a human being have been deciphered; for all intents and purposes, we have become software.





2014 marked an inflection point in the technology curve for medicine. It isn’t yet clear which technology advances will indeed affect humanity and which will be nothing more than cool science experiments. What is clear is that we have entered an era of acceleration and that there is much promise and peril ahead.