India had begun taking big steps to leverage technology in the healthcare sector much before the pandemic hit. In the segment of health-tech in India, polices can focus either on devices or technology or both. We take you through the public policy on this subject that has become more crucial since the spectre of COVID-19.
Budget for health-tech in India
To support these initiatives, the Union Budget 2018 allocated INR 3073 crores under NITI Aayog to set up a digital economy with emerging technologies like AI, IoT, blockchain and 3D printing. At the centre, the Ministry of Health and Family Welfare is the nodal ministry in-charge of making and regulating policies and standards related to health and health-tech.
In terms of medical devices, the National Health Policy (NHP) 2017 encourages the domestic manufacturing of medical devices in consonance with “Make in India”. The public policy also recommends the strengthening of regulation of medical devices. Since over 70% of all medical devices are imported into India, the policy also advocates the need to incentivise local manufacturing.
While the NHP 2017 provides overarching goals related to medical devices, the Medical Device Rules (MDR), 2017, which has come into effect from 1 January 2018, provides medical device-specific legislation in India. The MDR is issued under the Drug and Cosmetics Act 1940 and it regulates specific devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings. Meanwhile, the Ayushman Bharat scheme was lauded by the United Nations for deploying an effective health IT infrastructure.
NHP – National Health Policy
The NHP (2017), has specified goals for the adoption of digital technologies in healthcare. These include the creation of district-level electronic databases, interoperable EHR, registries for all diseases of public importance, to link systems across health providers at State and National levels consistent with Metadata and Data Standards (MDDS) for seamless sharing of data and services and envisaging health-tech ecosystem as a Federated National Health Information Architecture. It covers:
– Digital Health Ecosystem: The policy advocates for the extensive deployment of digital tools. The policy also aims at an integrated health information system which can serve the needs of all stakeholders and improve efficiency, transparency, and patient experience. Additionally, the policy advocates the creation of registries for improved data analytics, national health information network and the use of smartphones or tablets to capture real-time data. The policy promotes the use of digital tools for generating and sharing of information about Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) services and practitioners.
– Health Information System (HIS): The policy aims for the creation of an integrated HIS. This can be created through private sector involvement in developing and linking systems into a common network/grid, accessible to both public and private healthcare providers. Such a grid would record patient lists and document diseases and health events.
– Health System Strengthening: the policy aims to strengthen existing health systems through various means such as, creating a district-level electronic database of information on health system components by 2020.
– Medical Education: The NHP recommends and calls for the strengthening of existing medical colleges to meet human resource deficits in healthcare industry. The National Knowledge Network (NKN) is proposed to be used for telemedicine, tele-consultations and access to a digital library.
– Development of Information Databases: the policy calls for the development of information databases on wide variety of areas for the use of researchers. In this regard, the NHP recommends that data for all publicly funded health surveys should be available in the public domain.
Electronic Health Standards 2016
In order to introduce a uniform standardised system for creation and maintenance of health records by healthcare providers, the EHR Standards were notified in 2013 and updated in 2016 by the MoHFW. The primary aim of the EHR standards is to ensure structural and semantic interoperability of data across systems. The EHR standards refer to the adoption of a long list of International Standards Organisation (ISO) standards. It also presents criteria to enhance functionality, utility and security of IT for health-tech in India and to support its widespread adoption.
NeHA – National electronic Health Authority
The National electronic Health Authority (NeHA) was set up in 2015 under the MoHFW. NeHA acts as an enforcement body and is responsible for the enforcement of standards and ensuring security, confidentiality, and privacy of patient’s health information and records.
NeHA is also responsible for preparing technical and policy documents relating to architecture, standards and policies for EHR. Since health is a state subject in the Constitution of India, individual State electronic Health Authorities (SeHA) are responsible for enforcing standards set out by NeHA. As patient health records and medical data get digitised, data security and privacy become the next essential step to enforce.
NDHB – National Digital Health Blueprint
In response to the formulation of the National Health Stack, the MoHFW released the “National Digital Health Blueprint” (NDHB) in 2019. Building on the goals identified in the NHP 2017, the NDHB provides specific details required for fulfilling the vision of NHP 2017. It also provides an Action Plan for realising Digital Health.
National Strategy for Artificial Intelligence
The National Strategy for Artificial Intelligence launched in June 2018 focuses on how India can leverage the transformative technologies to ensure social and inclusive growth in line with the development philosophy of the government in five sectors, including healthcare. It pointed out that the market for health-tech in India driven by AI is expected to experience a CAGR of 40%.
Application of AI in healthcare can help to improve access to healthcare facilities, particularly in rural areas. It identified some applications such as AI-driven diagnostics, personalised treatment, and early identification of potential pandemics, which can benefit India. As per the strategy document, the focus is on the potential of AI combined with robotics and IoMT to address healthcare problems through research and training, early detection, diagnostic, decision making and treatment.
In this regard, NITI Aayog is launching a programme to develop a “Biobank of Cancer”. This will be an imaging repository of annotated and curated pathology images which will be used for cancer screening and treatment.
Health is a state subject in the Constitution of India and given the quasi-federal structure of governance, if policies are formulated at the centre it is up to the state health authorities to implement them. In line with the regulations of the MoHFW, the Bureau of Indian Standards (BIS) under the Ministry of Consumer Affairs, Food and Public Distribution regulates standards related to medical devices.
Apart from this, the NITI Aayog is the nodal agency for the Ayushman Bharat Yojana. The Department of Commerce under the Ministry of Commerce and Industry (MoCI) is in charge of trade in health-tech products and the DPIIT under the same ministry is in-charge of FDI in health-tech and export promotion of medical devices.
The Ministry of Electronics and Information Technology (MeitY), which is the nodal ministry in-charge of the “Digital India” programme, works in conjunction with the MoHFW and NITI Aayog to ensure greater digitalisation for health-tech in India.