Digital Healthcare – Regulatory Compliance In India
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<p><span class="TextRun SCXW181106995 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW181106995 BCX0">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. </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2 SCXW181106995 BCX0">Really</span><span class="NormalTextRun SCXW181106995 BCX0"> 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.</span></span><span class="EOP SCXW181106995 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p><p><span class="EOP SCXW181106995 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><img style="display: block; margin-left: auto; margin-right: auto;" src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/Sujeet+image+1.gif" /></span></p><p><span class="EOP SCXW181106995 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="TextRun SCXW60359554 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW60359554 BCX0">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 government's National Telemedicine Service, </span><span class="NormalTextRun SpellingErrorV2 SCXW60359554 BCX0">eSanjeevani</span><span class="NormalTextRun SCXW60359554 BCX0">, has clocked 1.4 crore consultations in last one year or around. In a significant move, the Ministry of Health and Family Welfare (“</span><span class="NormalTextRun SpellingErrorV2 SCXW60359554 BCX0">MoHFW</span><span class="NormalTextRun SCXW60359554 BCX0">”) 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.</span></span><span class="EOP SCXW60359554 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></p><p><span class="EOP SCXW181106995 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW60359554 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><img style="display: block; margin-left: auto; margin-right: auto;" src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/sujeet+image+2.jpg" /></span></span></p><p><span data-contrast="auto">The legal and regulatory framework in India is/will be govern by following relevant acts / bills –</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p><ul><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Telemedicine Practice Guidelines by MCI & NITI Aayog, 2020</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Data Protection Bill, 2021</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Information Technology Act, 2000 & Information Technology Rules 2011</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Clinical Establishment Act, 2010</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">MCI Act, 1956 & MCI Regulations 2002</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Indian Medical Council Act, 1956 and Indian Medical Council Regulations 2002</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Drugs & Cosmetics Act, 1940 and Rules 1945</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li><li data-leveltext="" data-font="Symbol" data-listid="1" aria-setsize="-1" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Other Service Providers Regulations under the New Telecom Policy 1999</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></li></ul><p><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><img style="display: block; margin-left: auto; margin-right: auto;" src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/sujeet+image3.jpg" /></span></p><p> </p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="TextRun SCXW254074069 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW254074069 BCX0">In addition, the </span><span class="NormalTextRun SpellingErrorV2 SCXW254074069 BCX0">MoHFW</span><span class="NormalTextRun SCXW254074069 BCX0"> 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 </span><span class="NormalTextRun SpellingErrorV2 SCXW254074069 BCX0">MoHFW</span><span class="NormalTextRun SCXW254074069 BCX0">, 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.</span></span><span class="EOP SCXW254074069 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW254074069 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><img style="display: block; margin-left: auto; margin-right: auto;" src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/sujeet+image+4.jpg" /></span></span></p><p> </p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW254074069 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="TextRun SCXW74005550 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW74005550 BCX0">Data Protection Bill, 2021 is a proposed law to regulate the collection and processing of both personal and non-personal data. The Data Protection Bill, 2021 includes 'health data' as sensitive personal data and defines it as the data related to the state of physical or mental health of the data principal and includes records regarding the past, present or future state of the health of such data principal, data collected in the course of registration for, or provision of health services, data associated with the data principal to the provision of specific health services. One of the most immediate changes that health tech companies may need to be prepared for is the cost of compliance – with the Data Protection Bill, 2021. 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).</span></span><span class="EOP SCXW74005550 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></span></p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW254074069 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW74005550 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><img style="display: block; margin-left: auto; margin-right: auto;" src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/sujeet+image+5.jpg" /></span></span></span></p><p> </p><p><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW254074069 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="EOP SCXW74005550 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="TextRun SCXW146665505 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW146665505 BCX0">If any Health Technology company or startup into Digital Healthcare plans to offer and add telemedicine/telehealth software to already existing software like healthcare EHR management systems, clinical software and hospital/clinic 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, in the event any technology platform is found in violation of the guidelines, then the Board of Governors may blacklist and no RMP will be permitted provide telemedicine on a blacklisted technology platform. As per draft Data Protection Bill 2021 there is provision of heavy penalties for serious data violations with fines up to Rs 15 crore, or 4% of global turnover, while lesser violations will have a limit of Rs 5 crore, or 2% turnover.</span></span><span class="EOP SCXW146665505 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></span></span></p>
KR Expert - Sujeet Katiyar
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