1. Digital Health
1.1 What is the general definition of “digital health” in your jurisdiction?
Digital healthcare is a multidisciplinary concept that is located at the intersection of healthcare and digital technology. Digital healthcare revolutionises the delivery of healthcare services for providers through the use of comprehensive platforms, tools and services. Mobile health applications, telemedicine, enterprise resource planning (ERP), customer relationship management (CRM), electronic health records (EHRs) and health information systems (HIS) are among the numerous technologies that contribute to the transparency of patient data. “Digital health” is a comprehensive concept that entails the integration of digital technologies with the healthcare sector to improve efficiency and provide more personalised patient care. The Digital Information Security in Healthcare Act of 2018 (DISHA) defines “digital health data” as an electronic record of an individual’s health-related information, despite the fact that the terms “digital health”, “digital medicine” and “digital therapeutics” lack specific definitions in India. The term “said data” generally refers to relevant information about an individual’s physical and mental health, the therapies they have received from healthcare providers, any donated body parts or biological materials, as well as the results of their testing and examinations. The integration of genetics and digital technologies exemplifies the concept of digital health, facilitating the early diagnosis and treatment of diseases. The World Health Organization (WHO) and the G20 India presidency introduced the Global Initiative on Digital Health (GIDH) during the Health Minister’s Meeting at the G20 Summit, which the Government of India convened on August 19, 2023. The new GIDH initiative will function as a network and infrastructure under the WHO’s supervision to facilitate the implementation of the Global Strategy on Digital Health 2020–2025.
1.2 What are the key emerging digital health subsectors in your jurisdiction?
Digital healthcare is a multidisciplinary concept that lies at the intersection of healthcare and digital technology. It incorporates a diverse array of technologies, such as telemedicine, ERP, CRM, EHRs and HIS, all of which enhance the transparency of patient data. The most significant emerging technologies in the field of digital health include m-health, digital pathology, telemedicine, health wearables, digital and social connectivity, big data analytics, virtual reality, ambupods, blockchain and electronic medical records. Increased awareness and adoption for the Internet of Things (IoT) and telehealth have made health-monitoring technology more accessible and cost-effective. The healthcare sector of India has undergone significant transformations as a result of the Digital India initiative. Initiatives like the Ayushman Bharat Digital Mission, CoWIN App, Aarogya Setu, e-Sanjeevani and e-Hospital have extended healthcare facilities and services to every corner of India.
1.3 What is the digital health market size for your jurisdiction?
The favourable legislation in India and the growing prominence of the digital healthcare industry have significantly improved the country’s use of digital technology. Industry experts anticipate the digital health industry in India to expand at a compound annual growth rate (CAGR) of approximately 29.5% from 2024 to 2032. Leading experts anticipate that the digital health sector in India will reach a valuation of USD 3.88 billion in 2023 and rise to USD 39.7 billion by 2032. It is anticipated that the Indian digital health market will experience growth due to the increasing prevalence of chronic conditions during the projected period. According to a customer market insights survey, it is expected that the Indian digital health market will reach USD 8.7944 billion in 2024 and expand at a CAGR of 17.67% between 2024 and 2033, ultimately reaching USD 47.8069 billion. The objective of digital health is to enhance the quality, accessibility and delivery of medical services by integrating technology with healthcare. It encompasses a diverse array of applications, such as telemedicine, mobile health applications, EHRs and data-driven, AI-powered personalised care. Insights10, a healthcare-focused market research agency, anticipates that the Indian digital health market will experience accelerated growth in the coming years as a result of its size and favourable government policies.
1.4 What are the five largest (by revenue) digital health companies in your jurisdiction?
Among the top five largest digital healthcare technology enterprises are Novartis, Stryker, Edwards Lifesciences, Centura Health and Hologic.
1.5 What are the five fastest growing (by revenue) digital health companies in your jurisdiction?
The more promising digital health start-ups and the fastest growing in India include 1mg, HealthifyMe, Netmeds, Cult.fit, Onsurity, HealthKart, PharmEasy and Innovaccer.
2. Regulatory
2.1 What are the principal regulatory authorities charged with enforcing regulatory schemes related to digital health in your jurisdiction? What is each authority’s scope of enforcement?
The Central Drugs Standard Control Organisation (CDSCO) is the primary regulatory body responsible for the enforcement of the Drugs and Cosmetics Act, 1940, and “rules made thereunder” (DCA). Furthermore, the Medical Council of India oversees the practice of medicine. Additionally, the Copyright Office is responsible for copyright, while the Office of the Controller General of Patents, Designs and Trademarks is responsible for intellectual property protection. The Department for Promotion of Industry and Internal Trade comprises both divisions. The Indian Council of Medical Research has also made significant contributions to the promotion of research in support of the National Digital Health Blueprint from the Ministry of Health and Family Welfare (MoHFW).
The following key acts typically govern the legal and regulatory framework:
- In 2011, the Information Technology Act (IT Act), consisting of the Information Technology Rules (IT Rules) of 2011 and the Sensitive Personal Data or Information (SPDI) Rules, came into effect.
- Requirements for other service providers under the New Telecom Policy of 1999.
- The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 and the Indian Medical Council Act of 1956.
- The Drugs and Magic Remedies Act of 1954 and the Drugs and Magic Remedies Rules of 1955.
- The Unsolicited Commercial Communications Regulations of 2007 and the Commercial Communication Customer Preference Regulations of 2010.
- The Clinical Establishments Act of 2010.
- The Digital Personal Data Protection Act (DPDP Act).
The Indian government is responsible for enforcing rules regarding digital health. These rules come from: the DCA; the IT Act and Rules, especially Sections 2(w), 43A and 79; the Clinical Establishments (Registration and Regulation) Act, Section 38(1) and 38(2); and Rules 3, 4(1), 5(1), 5(3), 5(7) and 7 of the IT Act. The regulatory authorities are responsible for enforcing reasonable security practices and procedures for SPDI, as outlined in: the Data Protection Rules; Rule 3 of the IT (Intermediaries Guidelines) Rules; the Medical Devices Rules; the DNA Technology (Use and Application) Regulation Bill; and the DPDP Act.
In order to protect the confidentiality of health-related information, it is imperative that medical professionals and patients implement data security measures. This information includes recommendations and outcomes. The Intermediaries Guidelines of 2011, the Data Protection Regulations of 2011 and the IT Act of 2000 are all intended to address this need and should be consulted in all circumstances. However, the rigorous compliance requirements have led to the establishment of no standards mandating the implementation of data security and protection. The rise of digital and other healthcare technology has raised patient privacy and data security concerns. When transmitting personal data, the most critical factors to consider are the preservation of confidentiality, the regulation of data transmission, the assurance of security and privacy, and the consideration of knowledge, trust, accountability and responsibility.
The MoHFW has proposed the National Digital Health Authority (NeHA) to facilitate the development of India’s Integrated Health Information System (IHIS). On August 11, 2023, the ratification of the DPDP Act, 2023, transformed India into a legal nation. India has implemented a new law to govern the administration of personal data. In addition to establishing a framework for the governance and accountability of data, one of its objectives is to preserve the privacy of individuals. The DPDP Act will have a substantial impact on the Indian healthcare industry, despite the fact that it is still in the early phases of digital transformation. The DPDP Act primarily focuses on digital personal data and does not address non-personal data. The implementation of the DPDP Act will render Section 43A of the IT Act and the IT (Reasonable Security Practices and Procedures and SPDI) Rules, 2011. These pieces of legislation address the legal and ethical concerns related to digital health.
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Authors: Manisha Singh and Dr. Pankaj Musyuni