Introduction:
The Government needs a robust technical infrastructure backing its goal to expand access to quality healthcare through the National Digital Health Mission (NDHM’). It needs technology solutions to create the various building blocks of the NDHM and to ensure effective health data management. This technical expertise is something the private sector can offer. The NDHM has created a sandbox to facilitate innovation, testing, and selection of technology solutions. Interested and eligible entities can participate in the sandbox ecosystem. Participation will not only provide solutions and insights to the Government but is also an opportunity for the private sector to engage in these solutions and potentially, the policies that regulate the ecosystem as a whole.
For the private sector to effectively offer solutions two things are important. Firstly, an understanding of the proposed NDHM ecosystem. And secondly, an understanding of the NDHM Sandbox.
National Digital Health Mission
This section provides a brief overview of how the NDHM will operate.
The NDHM aims to enable universal health coverage by leveraging appropriate technologies.[1] The NDHM will become an omnichannel healthcare solution ensuring that people have access to telemedicine, e-pharmacies, diagnostics, and insurance claims management. After interested individuals have been issued a health ID, they can access these solutions and store all records generated during their care.
The NDHM is a federated architecture, with systems that are interoperable and run with open-source software. The federated architecture will operate such that only the core building blocks will be developed and maintained centrally. Every other block will be designed to factor in interoperable platforms at the regional, state, and institution levels. The data gathered will be stored at the point closest to where it was generated. The table below lists the building blocks and the entities that can operate with these building blocks:
| Core Building Blocks | Description |
| Health ID | Every person wanting to be a part of the digital health ecosystem must get a Health ID. |
| Consent Manager Gateway | The exchange of health information is done through a consent manager and gateway. Health records can only be issued/viewed with patient consent. The consent manager supports requests, grants, and revoking of consent by users. |
| DigiDoctor | All doctors at healthcare providers that are participating in NDHM are required to enroll at the DigiDoctor. |
| Health Facility ID | All health facilities interested in participating in the mission must enroll for an ID. |
| Health Facility Registry | It is a registry of all hospitals, clinics, etc., where healthcare services are provided. |
| Entities that can integrate with these blocks | |
| Health Information Provider (HIP) | Any healthcare provider who creates health information in the context of providing healthcare. E.g., hospitals, clinics, diagnostics facilities. |
| Health Information User (HIU) | Any entity that would like to access the health records of an individual is called a Health Information User. E.g., hospitals, doctors |
| Health Repository Provider (HRP) | HRPs are the software service providers who offer NDHM compliant software and long-term record storage to hospitals, diagnostic centers, and clinics. HRPs enable healthcare providers to become HIPs or HIUs and to meet their obligations of sharing and securely maintaining health records of patients digitally. |
| Health Lockers | Health Lockers are software service providers who offer long term storage of records to individuals. Health Lockers also can store user uploaded health records. |
The NDHM has a Health Data Management Policy[2] to manage the interactions of the entities and the building blocks as well as to guide the data flow resulting from these interactions. Technology solutions are the backbone to implementing the Health Data Management Policy. Additionally, technology solutions need to be built for each building block to interact. Companies with the relevant expertise can contribute in both these areas.
The government intends to roll-out the NDHM in a phased manner, with a pilot currently running in the six Union Territories of India. The pilot involves creating and testing the building blocks, entities, and their interoperability through the NDHM Sandbox. The next section will dive a little deeper into what the NDHM Sandbox aims to do.
The NDHM Sandbox
NDHM Sandbox allows technologies or products to be tested in a contained environment. The Sandbox Guidelines (‘the Guidelines’)[3] guide participation in the Sandbox. The Information and Technology Ministry’s expertise has been taken to handle the technical aspects of the sandbox,[4] through its Standardization Testing and Quality Certificate Directorate (‘STQC’).[5] The STQC will provide quality assurance services for the software solutions proposed. Technologies or products will be assessed on their compliance with NDHM guidelines, while information on market and consumer reactions will be collected. Interested entities must comply with the Health Data Management Policy, the Personal Data Protection Bill, 2019,[6] and ensure their software solutions have been audited by the STQC. The STQC audit will ensure that the software solutions have the appropriate data protection and security controls.[7] The NDHM Sandbox will facilitate the integration of platforms and systems with the building blocks, enable responsible innovation in services, and promote efficiency.[8] Interested entities can apply through the NDHM Sandbox portal.[9]The Guidelines have an indicative list of the areas it is interested in[10]
- Products/Services – health clouds, e-pharmacy, health IDs, registries, telemedicine, electronic records
- Convergence and Expansion of NDHM – cybersecurity, digital KYC, smart contracts, health insurance/assurance, retail health
- Technology – data analytics, AI/ML applications, blockchain applications, other APIs, and mobile applications
- Participating in the NDHM as a user, provider, or repository.
Participation in the Sandbox: An engagement with future rewards?
The previous sections of this post laid out the structure of the NDHM and the role of the NDHM sandbox in ensuring a safe, efficacious roll-out of the NDHM. With this foundation, we can proceed to discuss why participation in this ecosystem is a good opportunity for the health-tech industry.
There are several reasons for the industry to participate. Firstly, participation in NDHM Sandbox is a great way for entities to showcase their technology solutions. The Guidelines themselves acknowledge that assessing compatibility with NDHM guidelines “will help organizations intending to be a part of the National Digital Health Ecosystem to become a HIP or HIU or efficiently link with building blocks of NDHM,” adding that “it paves the way for an institution/system to become a Health Information Provider or a Health Information User utilizing the NDHM technologies.” [11]
Secondly, participation in the NDHM Sandbox will create opportunities for interested entities to demonstrate practical challenges caused by the discord between regulations and technology solutions. It means that the Government can make informed policy decisions based on feedback from entities and users. An example of where this may be useful is the Health Data Management Policy, which needs to be periodically revised.[12]
Thirdly, it is becoming increasingly clear that the Health ID and NDHM’s federated and stacked ecosystem will be integrated with other projects. Take for example Niti Aayog’s paper on Public Health surveillance,[13] which aims to use aggregated and anonymized data from the NDHM to make better policy interventions in public health. If and when the Government does decide to begin such an integration, companies that have demonstrated capabilities needed for public health surveillance could find it easier to provide technological support for this integration.
Conclusion:
The NDHM needs technical expertise to create and sustain its ecosystem. The private sector is best placed to provide these solutions. Through its engagement, the private sector can bolster the technical infrastructure and ensure better health outcomes for patients. For example, AI/ML-based diagnostics or blockchain-based electronic health records management can improve the care a patient receives through the NDHM platform. However, the risks and costs of creating and sustaining such solutions can be daunting. Participation in the NDHM Sandbox can serve as a testing laboratory and a soft-launch for the entities interested in providing such solutions. Participation could also be a strategic entry point for these entities to continue engagement with the Government on digital health projects.
This article has been authored by Shambhavi Ravishankar with inputs from Anirudh Rastogi and Tanya Sadana. Anirudh Rastogi is Founding Partner, Tanya is the Principal Associate and Ravishankar is an Associate at Ikigai Law.
For more on the topic get in touch with us at contact@ikigailaw.com
Image credits: Pixabay
[1] Chapter 1: Context of the Mission, NDHM Strategy Overview: Making India a Digital Health Nation Enabling Digital Healthcare for all, July 2020 (Available at: https://ndhm.gov.in/assets/uploads/NDHM_Strategy_Overview.pdf)
[2] NDHM, Health Data Management Policy, https://ndhm.gov.in/health_management_policy
[3] National Digital Health Mission Sandbox, Enabling Framework v 1.0, August 18, 2020, (Available at: https://ndhm.gov.in//assets/uploads/Sandbox_Guidelines_v6.pdf)
[4] Para 8.12. at page 12 of the NDHM Sandbox: Enabling Framework v.1.0
[5] https://www.meity.gov.in/content/stqc
[6] “The data sharing shall be allowed based on approved Health Data Management Policy, Information Security Policy and any other policies as notified and applicable, and Data Protection Bill.” – Para 3.6. at page 6 of the NDHM Sandbox: Enabling Framework v.1.0
[7] Para 8.1.5 at page 12-15 of the NDHM Sandbox: Enabling Framework v.1.0
[8] Para 2.2. at page 6 of the NDHM Sandbox: Enabling Framework v.1.0
[9] https://sandbox.ndhm.gov.in/docs/participate
[10] Para 6, at page 7 of the NDHM Sandbox: Enabling Framework v.1.0
[11] Page 1 of the NDHM Sandbox: Enabling Framework v. 1.0
[12] Clause 34.3, Health Data Management Policy, (https://ndhm.gov.in/health_management_policy)
[13] Vision 2035: Public Health Surveillance in India” December 14, 2020 (Available at: https://niti.gov.in/sites/default/files/2020-12/PHS_13_dec_web.pdf)
