October 2020

The Patents Act, 1970 provides patent protection in India which is compliant with Trade-Related Aspects of Intellectual Property Rights (TRIPS) and has been adopting and implementing the provisions. To obtain a patent protection in India, apart from the patentability criteria-novelty, inventive step and industrial applicability, the invention must not fall within the ambit of Section 3 and 4 of the Act. As any digital health application works on software and a computer program, Section 3(k) of the Indian Patents Act is relevant which precludes patentability of a computer program per se. Recently, the Delhi High Court has iterated that all computer programs are not barred under Section 3(k) and when such program demonstrates a ‘technical effect’ or a ‘technical contribution’, the invention would be patentable.

The key issues in sharing personal data are primarily, but not limited to: the transparency and control of data exchange; security and privacy; and information, trust, responsibility and accountability. Such considerations can change during data sharing, particularly data protection and privacy, as this is an important concern.

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. In addition, the National Digital Health Authority (NeHA) under MoHFW is a proposed authority that is intended to be responsible for the development of an integrated health information system in India. It is proposed to be a promotional, regulatory and standard-setting organisation to guide and support India’s journey with Digital Health and consequent realisation of benefits of ICT intervention in the health sector. It also spells out the proposed functions and governance mechanism of NeHA. DISHA is the legislation that seeks to formally establish NeHA and facilitate the online exchange of patient information with a view to prevent duplication of work and streamline resources.

Data Privacy is a main concern in the use of personal data. In September 2013, the MoHFW notified the Electronic Health Record Standards (EHR Standards) for India. They were chosen from the best available, previously used standards applicable to international electronic health records, 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 Systematised 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.