Digital Health Laws and Regulations India 2024

Digital Health Laws and Regulations India 20241. Digital Health

1.1        What is the general definition of “digital health” in your jurisdiction?

The term “digital health” signifies a broad idea that entails establishing an alliance among digital technologies and the healthcare business in order to improve healthcare efficiency and provide patients with more personalised care.  Although the phrases “digital health”, “digital medicine” and “digital therapeutics” are not specifically defined in India, the Digital Information Security in Healthcare Act of 2018 (DISHA) defines “digital health data” as providing an electronic record of an individual’s health-related information.  The relevant information on a person’s physical and mental health, the treatments they have gotten from health providers, any body parts or biological material they have donated, and test and examination results are often included in the term “said data”.  The integration of genetics and digital technologies for early disease detection and treatment best exemplifies the concept of digital health.

1.2        What are the key emerging digital health technologies in your jurisdiction?

Many businesses have embraced digital transformation as a fact of the information age.  After all, it is important to provide value to customers.  M-Health, digital pathology, telemedicine, health wearables, digital and social connectivity, big data analytics, virtual reality, ambupods, blockchain and electronic medical records are some of the key emerging digital health technologies.

1.3        What are the core legal issues in digital health for your jurisdiction?

Data security is necessary for ensuring the privacy of health-related information shared between patients and medical practitioners, including recommendations and outcomes.  The Information Technology Act of 2000 (IT Act), the Intermediaries Guidelines of 2011 and the Data Protection Rules of 2011 are meant to address this need and should be consulted in every circumstance; however, no standards have been developed to mandate the implementation of data security and protection due to their stringent compliance requirements.  Concerns around patient privacy and data security are also increasing in tandem with the proliferation of digital and other advanced healthcare technologies.  The key concerns with transmitting personal data include confidentiality, data exchange control, security and privacy, as well as awareness, trust, accountability and responsibility.

The Ministry of Health and Family Welfare (MoHFW) has suggested establishing the National Digital Health Authority (NeHA), which will be responsible for developing India’s Integrated Health Information System (IHIS).  It is proposed that it serve as an agency that supports, monitors and establishes policies to lead India’s transition to digital health and the benefits gained in the health sector.  On August 11, 2023, India passed the Digital Personal Data Protection Act, 2023 (DPDP Act).  This new law governs how personal data is handled in India.  It aims to protect people’s privacy while also establishing a framework for data accountability and governance.  The DPDP Act will have a significant impact on the Indian healthcare sector, which is still in the early stages of digital transformation.  The DPDP Act, which is focused on digital personal data, does not cover non-personal data.  When the DPDP Act’s provisions take effect, the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data of Information) Rules, 2011 (SPDI Rules) and Section 43A of the IT Act will be superseded.  These pieces of legislation address the legal and ethical challenges in digital health.

1.4        What is the digital health market size for your jurisdiction?

In light of the growing prominence of digital healthcare business and favourable government policies, India’s digital adoption has increased significantly.  The digital health industry in India is expected to increase from $3.83 billion in 2022 to $18.34 billion by 2030, at a CAGR of 21.6% between 2022 and 2030.  According to Insights10, a healthcare-focused market research agency, a combination of a vast potential market and supporting government regulations is projected to generate robust growth in the Indian digital health market in the coming years.

1.5        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.  More promising digital health start-ups in India include Netmeds, HealthifyMe,, PharmEasy and Innovaccer.

To read more visit the Chapter first published by: Global Legal Group here

Authors: Manisha Singh and Pankaj Musyuni