The Ministry of Health of Family Welfare, Government of India circulated the ‘Health Data Management Policy’ (Policy Proposal hereafter) for feedback and consultation on 26th August 2020. This Policy Proposal will serve as the fulcrum for the National Digital Health Blueprint through which the government aims to build a ‘federated’ digital architecture to further the goals of the National Health Policy. The proposed digital architecture is expected to be available to all healthcare providers and users, as well as entities such as pharmaceutical and insurance companies.
The Policy Proposal is a ‘guidance document’ to regulate the vast amounts of data that will be generated and processed under this architecture. Admittedly, the driving force for the proposal is the necessity of safeguarding privacy of confidential health data. It seeks to build on the Personal Data Protection Bill, 2019 (PDP Bill, 2019), which is currently under consideration in Parliament. The utility of building a digital health ecosystem has long been accepted. Its benefits include improved access to health records across primary, secondary and tertiary healthcare, improved decision making for service delivery and research for innovative solutions. Both the Policy Proposal and the PDP Bill, 2019 aim to set out a legal framework against which entities in the health ecosystem may undertake such exercises.
The consultation process for the Policy Proposal is underway till 21st September, 2020. In this note, we analyse the key points of departure between the Policy Proposal and the Personal Data Protection Bill, 2019, with regard to three aspects:
- Key Definitions
- Consent Framework
- Obligations on Data Fiduciaries
The Policy Proposal clarifies at the outset that no entity shall be entitled to any rights greater than what are already available under other applicable laws, which will presumably include the PDP Bill, 2019 and rules and regulations formed under this legislation once it is passed by Parliament. Readers can find a clause-by-clause comparison of the Policy Proposal and the PDP Bill, 2019 in the annexure to this note.