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NeHA: India’s proposed digital health regulatory authority

I feel strangely vindicated and comforted that the Indian government is soon to launch its latest regulatory agency – the National e-Health Authority (NeHA) – that was reported in the media today (see: here).

In a series of blogs that I published here on LinkedIn – you may read them hereherehere, and here – I took readers on a rambling walk through fictional stories and an interview that described the need, scenario, possible structure, and process by which such an agency would radically transform healthcare in the country. My blogs took a preventive care perspective, but the same structure and process could also adapt to other encounter modalities.

Clearly, the time has come for such a huge nation to begin seeking to put its mammoth, highly fragmented, and disturbingly low quality of healthcare delivery under some kind of omnibus regulatory guidelines that defines the technical and stakeholder interaction scenarios, data guidelines, storage, security and privacy, and interoperability standards. All these today are becoming de rigueur with the increasing penetration of smartphones, availability of advanced sensors for continuous and episodic monitoring, increasing network bandwidth, speedy processors, rapid diagnostics, inexpensive (and falling) cost of individual genomic data, social media, and customer assertiveness to drive their own healthcare needs.

Eric Topol calls the imminent, and much-delayed, the arrival of digitized medicine as the “new era” in healthcare that would result in the creative destruction of the contemporary practice of medicine as we know it. This traditional medical practice that we are all familiar with today is built on the foundations of population medicine practiced over hundreds of years whereby evidence was derived from populations to enable clinical research to give us the drugs that made its way into the markets for specific indications; dosages that were determined for populations during clinical trials and approved by regulatory agencies that doctors then followed in their prescriptions; and in the embrace of vital parameters such as blood pressure defined on the basis of averages. In fact, “averages” succinctly describes how healthcare is practiced, and they are based on whole populations, not individuals who could – and often do – deviate from the mean. As Dr. Topol notes, “the result is that most of our screening tests and treatments are overused and applied in the wrong individuals, promoting vast waste”. For many years now, he has been calling for a “jailbreak”.

A jailbreak moment

But the world that Dr. Topol envisions of digitized and personalized medicine (some call this precision medicine) is quite some distance away, even in the developed countries. More than technology, the constraints lie in the conservative practices of clinicians and a risk-averse regulatory regime that, together, have ensured expensive drugs and devices, insurance reimbursement challenges, paperwork compiled from disparate silos, and the resulting high cost of care delivery. He notes that the American Medical Association has historically lobbied for doctors to serve as gatekeepers and to not vest clinical data ownership and choice in the consumer.

In India, the newly launched NeHA represents a jailbreak moment in the nation’s healthcare. While individual genomic data and the potentially exciting future it represents for individualized medicine is not of immediate concern or use, a brand new regulatory agency gives leeway for the government to shape the contours of regulation that addresses lacunae that have been ignored or inadequately impacted. Here, we are still faced with the following issues that I had outlined in one of my blogs (Indian Healthcare: Some Conclusions), to wit: low national healthcare expenditure, poor performance in terms of outcomes, poor care delivery, private sector-led in the face of state retreat, chronic disease epidemic, and the household burden of everyday health.

Building on the “IndiaStack”

All the same, NeHA (assuming the government comes through with this and inaugurates the new regulatory agency and gives it legislative teeth) represents a singular moment in Indian healthcare. More importantly, it comes on the back of other initiatives – all falling within a concept called “IndiaStack” – that have been sequentially and deliberately put in place in the last few years. This includes universal identification reposed within a federal agency, the Unique Identification Authority of India (UIDAI, that issues the Aadhaar identity based on several biometrics), nationwide bank accounts for every adult based on Aadhaar in the pursuit of financial inclusiveness, direct benefit transfer (DBT, that directs all subsidies to citizens directly into their bank accounts), and Unified Payments Interface (UPI, launched by the National Payments Corp of India and based on Aadhaar that highly simplifies payments and transfers on a mobile phone).

The authors of the news article cited above allude to the proposed National Health Protection Scheme that, together with the unique identity, could drive a nationwide healthcare information systems. We do not yet know what kind of regulatory burden would be reposed within NeHA, but my wish list would include the following:

  1. Set standards for a national backbone architecture and define the protocols for connectivity, interoperability, data portability, ownership and trustee, privacy and confidentiality, governance, and registration and regulation of healthcare data brokers akin to what one sees in the financial services industry.
  2. Be the champion of open data and define standards for application programming interfaces or APIs.
  3. Qualify, assess, and certify all stakeholders in the healthcare ecosystem in their technology readiness and acceptance into a nationwide connected healthcare world.
  4. Perform the role of a “national switch” in identifying and authenticating citizen encounters with the healthcare system using the national ID and map it to electronic health record (EHR) repositories to complete records retrieval and enable all insurance and non-insurance models to co-exist for transactional payments.
  5. Be the primary guardian of citizen rights in matters relating to healthcare data, ownership, access, portability, and foster and enable the context for rational choice by citizens.

If NeHA achieves the above and addresses the five drivers of healthcare in the country – accessibility, availability, assessability, affordability, and archetypical – it would not just be a jailbreak moment, it would be revolutionary and serve as a model for other nations.