2024年印度的数字健康（英）.pdf

Nishith Desai Associates MUMBAI SILICON VALLEY BENGALURU SINGAPORE NEW DELHI NEW YORK GIFT CITYResearchDigital Health in IndiaAugust 2024 Nishith Desai Associates ResearchDigital Health in IndiaAugust 2024DMS Code:30667.1 Nishith Desai Associates Ranked as the Most Innovative Indian Law Firm in the prestigious FT Innovative Lawyers Asia Pacific Awards for multiple years.Also ranked amongst the Most Innovative Asia Pacific Law Firm in these elite Financial Times Innovation rankings.Digital Health in India Nishith Desai Associates 2024Provided upon request only DisclaimerThis report is a copyright of Nishith Desai Associates.No reader should act on the basis of any statement contained herein without seeking professional advice.The authors and the firm expressly disclaim all and any liability to any person who has read this report,or otherwise,in respect of anything,and of consequences of anything done,or omitted to be done by any such person in reliance upon the contents of this report.ContactFor any help or assistance please email us on or visit us at .AcknowledgementsDr.Milind AntaniMEshika PhadkeETanya KVarsha R Digital Health in India Nishith Desai Associates 2024Provided upon request only ContentsIntroduction 1Applications of Digital Health 3A.TelemedicineB.Point-of-Care Diagnostics C.m-HealthD.Medical Virtual Assistants E.Robot-Assisted SurgeryF.Self-Monitoring Healthcare DevicesG.Electronic Health Records(“EHR”)H.Health Service AggregationI.Big Data in HealthcareJ.Blockchain in Healthcare K.Targeted advertisingL.e-PharmaciesM.e-Learning in the healthcare sectorAyushman Bharat Digital Mission 8A.Health Data ManagementB.SandboxC.Unified Health Interface D.Proposed Health Data Retention Policy Investment in Digital Health 12A.Foreign Direct InvestmentB.Foreign Venture Capital InvestmentLegal and Regulatory Framework 14A.Drugs and Cosmetics Act 1940 read with Drugs Rules 1945 and Draft E-Pharmacy Rules,2018 B.The National Medical Commission Act,2019 and The National Medical Commission Registered Medical Practitioner(Professional Conduct)Regulations,2023C.Telemedicine Practice Guidelines,2020D.The Drugs and Magic Remedies(Objectionable Advertisements)Act,1954 and Drugs and Magic Remedies(Objectionable Advertisements)Rules,1955(“DMRA”)E.The Clinical Establishments(Registration and Regulation)Act,2010 F.Telecom Commercial Communication Customer Preference Regulations,2018(“TCCP Regulations”)G.Consumer Protection Act,2019 and Consumer Protection(E-commerce)Rules,2020 H.Proposed Law Digital Health in India Nishith Desai Associates 2024Provided upon request only Data Protection 19A.The Information Technology Act,2000,the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or information)Rules,2011(together the“Data Protection Rules”)and the Information Technology (Intermediary Guidelines and Digital Media Ethics Code)Rules,2021 B.The Clinical Establishments(Registration and Regulation)Act,2010,Clinical Establishments Rules,2012,and Electronic Health Record Standards,2016C.Health Data Management Policy,2020(“HDM Policy”)D.Data Security Council of India Privacy Guide for Healthcare,2021Intellectual Property 22A.PatentB.CopyrightC.DesignD.TrademarkE.Trade SecretsTaxation Regime 25A.Direct TaxesB.Indirect TaxesC.Structuring investmentsLiability and Dispute Resolution 28A.Suits before a Civil CourtB.Vicarious LiabilityC.Liability under CPAD.Disciplinary Action by the NMCE.Criminal LiabilityCurrent Issues and Considerations 31A.TelemedicineB.m-HealthC.e-PharmaciesD.MVAsRecommendations 34A.EHR System B.E-PrescriptionsC.Technical Reliability and Appropriateness D.Ascertaining Role of Patients E.Role of Healthcare Professionals Conclusion 36 Digital Health in India Nishith Desai Associates 2024Provided upon request only 1Introduction“There are two areas that are changing these are information technology and medical technology.Those are the things that indicate that the world will be very different twenty years from how we know it today.”Bill Gates 1 Ben Tarnoff,How Internet Was Invented?,The Guardian,available at:https:/ WHO Guideline on Recommendations on Digital Interventions for Health System Strengthening,World Health Organisation,available at:https:/apps.who.int/iris/bitstream/handle/10665/311941/9789241550505-eng.pdf?ua=1.3 Digital Health,World Health Organisation,available at:https:/www.who.int/health-topics/digital-health#tab=tab_1.When the internet was first created in the 1980s,the primary objective was to get computers to speak the same language to enable data to travel across any network.1 Over a period of time,internet has transformed communication,business,education and governments.One of the toughest and most distinctive penetra-tions of internet is into the healthcare sector.Traditionally,healthcare is perceived as the improvement and maintenance of health through diagnosis,treatment and prevention of ailments through the application of knowledge and skill of healthcare professionals.Today,in the advent of digital technologies in healthcare,healthcare delivery has become personalized and precise and need not necessarily involve the direct intervention of a healthcare professional.The term“Digital Health”is all encompassing and includes all applications emerging from the intersection of healthcare and technology.The World Health Organisation defines digital health as“a broad umbrella term encompassing eHealth,as well as emerging areas,such as the use of advanced computing sciences in big data,genomics and artificial intelligence.”2 Digital Health technology has emerged as a pivotal pillar in the delivery of healthcare.In the recent past,the world has witnessed a boom in the health technology market for products such as wearables,telemedicine,e-pharmacies,etc.In addition,there has been tremendous research and development in the integration of technologies such as robotics,artificial intelligence,blockchain and virtual reality with pharmaceuticals and healthcare where the sector is experiencing gamification of non-game activities to promote better health management.Accurate delivery of healthcare through technologies and traditional means is also being bridged through the incorporation of ambient computing techniques.The use and scale up of digital health solutions can revolutionize how people worldwide achieve higher standards of health,and access services to promote and protect their health and well-being.3In recognition of this impact,the Government of India launched the flagship programme Digital India Campaign in 2015 which included public health initiatives geared towards adoption of digital technologies for penetration of healthcare services in rural areas.Subsequently,the National Health Policy in 2017 envi-sioned a fully digitized healthcare system in India which culminated in the commencement of the Digital Health Mission in India(now known as the Ayushman Bharat Digital Health Mission).Digital Health in India Nishith Desai Associates 2024Provided upon request only 2 Introduction This increased focus and endorsement of digital health by the Government makes India a conducive market for innovation in healthcare and creates numerous opportunities for investment.In the absence of a specific Digital Health law,this paper seeks to knit together existing laws and regulations into what may be called an“ad-hoc”legal framework for Digital Health in India.It is being written for those who are already invested in Digital Health as workforce or capital contributors as well as those who are still testing the waters.Since this is a research paper,it also seeks to raise questions and take positions which are yet to be tested with the hope that it would set the tone for legal discussions on larger platforms.Digital Health in India Nishith Desai Associates 2024Provided upon request only 3Applications of Digital Health 1 Ashok Vikhe Patil,K.V.Somasundaram and R.C.Goyal;Current Health Scenario in Rural India;available at http:/www.sas.upenn.edu/dludden/WaterborneDisease3.pdf.The term“Digital Health”represents a broad range of applications.Any use of information technology and communications to manage health and wellness falls within the ambit of digital health.Few key applications have been discussed below:A.TelemedicineTelemedicine is the use of telecommunications technology to provide healthcare.While telemedicine is not a separate specialty,it stands out in the use of various technologies in providing traditional healthcare services remotely.It is a broad concept that covers within its ambit various aspects such as tele-radiology,tele-consultation,tele-nursing,tele-ICU and tele-surgery.Telemedicine can be a particularly useful tool to improve treatment outcomes in India as over 75%of the countrys healthcare infrastructure is concentrated in urban areas while more than 75%of the population lives in rural areas.1 Telemedicine could effectively bridge the gap between the patient and the doctor and enable greater access to healthcare to the masses.B.Point-of-Care Diagnostics Point-of-care Diagnostics(“POCD”)is an emerging trend in the medical device industry and encompasses a broad range of products which enables accurate diagnostics in resource limited setting by patients themselves or healthcare practitioners.It facilitates disease management,monitoring and real-time diagnosis of multiple conditions.In the recent past multiple applications such as biosensors,portable x rays,handheld ultrasounds and smartphone based POCD have been developed.Conventional clinical diagnostic procedures which generally require expensive and sizeable instruments have been simplified into software or portable POCD devices which can be used at the site of the patient as opposed to a hospital or a laboratory.POCD devices are generally automated technologies which run on artificial intelligence and/or machine learning algorithms which enable the simplification of complex diagnostic procedures to provide immediate test/diagnosis results.These results can be used by the patient to approach a healthcare professional for further accurate diagnosis and treatment plans.Additionally,implantables such a bio-sensors help with continuous monitoring of a particular health condition.They have the potential to provide real-time and accurate results and therefore are useful for point-of-care analysis.This enables tracking,monitoring and management of the disease which can directly aid medical decision making of the patient and prognosis of physicians since it generates large data sets of minute health changes.Digital Health in India Nishith Desai Associates 2024Provided upon request only 4 Applications of Digital Health Alternately,it is also beneficial in countries such as India where high-grade medical facilities and infrastructure is deficient in rural areas.POCD will enable physicians to provide telehealth services after diagnosis through POCD devices without requiring patients to physically travel and undergo diagnostic tests at medical facilities.C.m-HealthMobile health,or m-Health,is the provision of Digital Health services on a mobile platform.India is home to the 2nd largest smartphone market in the world,which makes m-Health a very lucrative option 2.Providing access to such applications on smartphones is easily achievable,given that the country is expecting to reach 1412 million mobile internet users by 2024,given that the number of smartphone users and internet users are nearly the same.3 The convenience of Digital Health coupled with the mobility of m-Health opens the arena for a lot more players to actively take part in the revolution.D.Medical Virtual Assistants Medical Virtual Assistants(“MVAs”)is an emerging trend in the m-Health landscape.Virtual health assistants and chatbots bridge the gap between patients and physicians and tend to the needs of the patients in between physical appointments through services such as prompting prescription refills,providing information on medical conditions,appointment scheduling,maintain health records and other administrative tasks.MVAs generally run on AI based software to enable the processing of large data sets and provide personalised advice and perform individual specific functions.MVAs are also advantageous for performing administrative tasks at hospitals and other healthcare institutions.E.Robot-Assisted SurgeryUsing the assistance of robots,doctors are able to perform surgical procedures more efficiently.Minimally invasive surgeries have been around for a while,but with the assistance of robotics,surgeons are able to manoeuvre more precisely and with smaller incisions.4 This ultimately leads to reduced loss of blood,better pain management and quicker recovery for the patient.Going forward we may also witness the use of microbots(also called micro-robots)for diagnosis and treatment of diseases.One such procedure called capsule endoscopy,in which the patient swallows a tiny camera so that the healthcare provider can take pictures of the digestive tract,has already been approved by the United States Food and Drugs Administration(US FDA-the apex regulatory body governing drugs and medical devices in the United States of America).5 Other applications in the future may include removing plaque from arteries,taking tissue biopsies,attacking cancerous tumors directly and delivering targeted medication in the human body.2 India is now the second largest smartphone market in the world,surpassing the U.S.,available at:https:/ Number of internet users in India,available at:https:/ Johns Hopkins Medicine;Types of Minimally Invasive Surgery;available at:http:/www.hopkinsmedicine.org/minimally_invasive_robotic_surgery/types.html.5 The Growing Emergence of Robots in Healthcare:Key Opportunities&Benefits,available at:https:/H Health in India Nishith Desai Associates 2024Provided upon request only 5 Applications of Digital Health Microbots are far less likely to cause tissue damage than conventional medical interventions,such as surgical incisions and catheter insertions.By aiming for specific destinations in the body,microrobots could drastically reduce the side effects of pharmaceuticals.6 Further,with advancements in deep learning,robots would be able to observe and replicate procedures that are simple and repetitive,while the surgeon concentrates on more complex tasks.7F.Self-Monitoring Healthcare DevicesMonitors and sensors are now being integrated into wearables,which allow it to detect various physiological changes in the body.These smart devices are capable of tracking weight,sleep patterns,blood pressure,glucose levels,8 posture,diet and exercise.9 The raw data that is collected can be used to self-monitor by detecting various health symptoms and alert the user in case of potential issues.G.Electronic Health Records(“EHR”)An EHR is a digital version of a patients health records.EHRs help eliminate the problems associated with physical records such as loss and lac