Embrace new health tech, but with due safeguards
Operate new technologies within an ethical framework, a robust regulatory process, and a new legal architectureUpdated: Jul 20, 2020, 22:32 IST
Since the spread of Covid-19, optimism in the potential of health technologies to strengthen the Indian health system has been evident. While much attention is focussed on digital contact tracing, other technology-based interventions, such as portable ventilators, isolation pods, digital stethoscopes, devices to collect and dispose body fluids and robots to collect contagious waste, have also emerged. Many advocate building an enabling infrastructure, providing fiscal incentives and easing regulatory processes to encourage innovation in health technologies.
Some scepticism may be needed. After all, hasty adoption of new health technologies risks harming patients and consumers of these technologies. Harm may be caused due to defects in the technology, lack of training for health care workers, negligence in operating, and breaches of confidential personal data. Recently, hospitals in Delhi and Mumbai flagged key defects in a set of low-cost ventilators of one manufacturer, and variance between the actual performance of the ventilator and performance registered on the device display. Since the pandemic, health care organisations have experienced a surge in medical data theft and ransomware attacks using digital medical devices. Technology experts have warned against serious risks to personal privacy posed by Aarogya Setu, the Indian contact tracing mobile app.
The risk of harm is exacerbated because the present regulatory processes (involving the Indian Council of Medical Research and government approvals) are thin on detail, lack transparency and are unaccountable. Moreover, the health tech market is nascent, uncertain and rapidly evolving. In a recent interview with The Economic Times, the chief development officer at Genpact identified lack of skills to design, implement and maintain artificial intelligence (AI) solutions, and a lack of clarity on where to use such solutions effectively, as some of the key barriers to the adoption of AI across industries.
The question then is how can the regulatory framework governing health technologies encourage effective innovations without compromising patient safety and security? Here are some considerations that address this dichotomy.
First, ethical concerns rooted in the importance of harnessing health benefits as well as avoiding personal and social harm, are at the centre of this debate. This warrants consensus and articulation of ethical principles that guide health tech interventions. One important principle, the right to privacy, was recognised as a fundamental right by the Supreme Court of India in KS Puttaswamy vs Union of India. Other principles, such as public oversight, minimising the risk of error, facilitating equitable access, respecting individual autonomy and deploying the least burdensome alternative to accomplish the public health objective, are also driving the thinking in public health ethics.
Second, we need a comprehensive framework for evaluating health tech solutions. Health Technology Assessment (HTA) is a recommended practice for assessing safety, cost and cost-effectiveness, social and organisational implications, legal and ethical considerations, clinical efficacy and effectiveness of a health tech solution. India has the institutional setup for HTAs since 2017. Although a few reports on some earlier interventions are available on the website, there is no publicly available evaluation of any of the health tech solutions implemented in the wake of the Covid-19 pandemic. There is an urgent need to harness and augment this existing capacity.
Third, regulation of the health tech market should be accompanied with reforms in other areas of health care. Two aspects of regulation come to mind. One is ex-ante measures that mandate health care workers to undergo adequate training before operating a health tech application. Additionally, an overarching data protection law will assuage privacy concerns related to digital medical data. The other is ex-post measures that create liability in cases of deficiencies in a health tech application, inadequate training of health care workers, and mistakes or negligence in implementation.
Finally, there is merit in mobilising technology to improve capacity in the Indian health system. Hence, the government should facilitate an enabling environment for innovation in the health tech market. This need not be limited to fiscal incentives. One way is building capacity for early HTAs, a practice followed in countries such as Thailand and Singapore.
Early HTAs assess the potential added value of hypothetical health technologies that can inform decisions on earlier stages of product development. Such evaluations will not only aid tech companies and research institutions to manage their product development portfolios while maximising societal benefits, they will also accelerate the decision-making process of the government once the product is ready.
Successful implementation of any technological intervention, including health tech applications, is based on public trust and confidence. A comprehensive and reliable regulatory framework will facilitate this. The Health Technology Assessment Board Bill 2019 is a step in the right direction. In its present form, the bill lays out the structure, powers and functions of the board. It needs to be strengthened to institutionalise ethical systems for HTA analysis, keeping in mind the principles highlighted earlier. Considering the rapid pace of development of the health tech market and its implications, the bill should be reinforced and prioritised in the coming parliament session.
Law and Policy, ILS Law College, Pune