Digitalising various segments of the healthcare value chain over the past years is becoming more prevalent and accessible. Digital health has become ever more important in this year as the COVID-19 pandemic spread throughout the world. Given its rise in popularity, regulatory policies for digital health are essential to guide digital health companies and programs to provide people with safe and better digital health services
Based on a report by Accenture released in July 2020, 85 percent of health executives acknowledge that digital health technology has become an inseparable part of the human experience in healthcare. With increasing number of industrial players entering the digital health ecosystem and health consumers looking for more from the current digital health services, regulatory policies have to be laid out to guide the development of such technology. In the report by Accenture, 70 percent of healthcare consumers are “concerned about data privacy and commercial tracking associated with my online activities, behaviours, location and interests.” The rise in wearable digital health technology for tracking a person’s health has also posed a concern for where and how the data collected by the service provider is being used. Consumer confidentially and cyber security are just some of the key issues that have to be addressed as digital health technology takes over the healthcare sector.
December 2019, the Health Sciences Authority in Singapore published a set of guidelines for digital health, “Regulatory Guidelines for Software Medical Devices – A Lifecycle Approach”. These set of guidelines laid out clearly regulatory requirements for software medical devices in its entire life cycle and also the key points to note from the beginning of product development. The guidelines included quality management systems (QMS), pre-market product registration requirements, as well as addressing important issues that could arise such as cybersecurity and requirements for artificial intelligence medical devices.
Dr Rama Sethuraman, Director for the Medical Devices Branch at Health Sciences Authority, shared in the recent APACMed Conference held in September 2020, that in 2017 the Singapore Health Sciences Authority (HSA) implemented and worked on device development consultation due to the growing demand for it in the ecosystem.
“[We] started meeting developers from diverse groups, and saw that over 40 percent of our meetings, our software and file application related products and quite a substantial amount, also for the artificial intelligence these devices.” Said Dr Rama.
“What we constantly see is that while regulatory principles or safety, quality efficacy principles are still relevant, the need was more to contextualize it and help these groups to understand how what it means for software products, and how they're going to apply these standards for the regulatory compliance purposes.” Said Dr Rama.
She then shared that the HSA adopted the lifecycle approach as many of the developers are, “not traditional medical device manufacturers, they are not familiar with what is the importance of post market surveillance what they need to recall, there are a lot of knowledge gaps there. Looking at all the various questions [HSA] normally receives and the challenges, we decided to do a lifecycle approach rather than tackling the market still going for traditional methods.”
The Department of Health in Australia has also set up their own set of regulations for software as a medical device. Outlined by the Therapeutic Goods Administration (TGA) in Australia, guidance and regulations were intended to apply to software and applications that meet the legal definition of a medical device in Australia. In its support and understanding of the ecosystem, TGA opened consultations with key industry stakeholders to seek out feedback from interested parties for the validity and usefulness of regulatory guidelines drafted for software as medical devices. It also helped to address cyber security of these digital health applications.
“We are dealing with a large number of new market entries to this area. The other part of the equation was how to put a boundary around digital health because medical device regulation is only one component of digital health, and how a digital solution can improve the efficiency and effectiveness of the healthcare sector.” Said Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division for Therapeutic Goods Administration (TGA), Australia
Tracey Duffy also shared that, “What we were struggling with was trying to understand where regulation plays a part where the greatest harm could potentially occur to patients. Would there be a different risk profile if there was a health care professional involved in using the device or piece of software, and what role and function does the consumer or the patient have to own and self-manage their own health in the current environment when there is so much information around through the internet.”
According to Tracey Duffy, the TGA set out to change classification rules and central principles and be critical to the types of products that were being developed, where in many cases to look at potential harm the development of the software lifecycle could bring. Also, which part should be regulated and how regulation should be carried out.
“Our most recent consultation paper sought feedback from any interested parties about where those boundaries should lie, and what it's shown us is that there are a considerable number of medical devices that are would normally come under our regulation.” Said Tracy Duffy.
She also highlighted that the TGA understood that education and awareness of digital health developers who are entering the ecosystem might not be familiar with the regulations. “We wanted to use this as an educational tool to find out what are the tools that they require us to develop when we do, put the boundaries in place. Supporting them to understand how to comply and have a light touch approach where it's needed, and focused on those high risk, medical devices where well, if it needs to be made.” Said Tracy Duffy.
With the vast number of digital health services emerging and increase use and demand by consumers, we next need to understand what is the sufficient capacity required to build appropriate frameworks for digital health.
“There needs to be capacity building not just for regulators but certainly for industry, especially the new players entering the ecosystem.” Said Professor John Lim, Duke- NUS Medical School, Executive Director of the Centre of Regulatory Excellence (CoRE) and Policy Core Lead of the SingHealth Duke-NUS Global Health Institute (SDGHI)
At CoRE, training modules have been developed specifically focussing on pharmaceutical regulation and to help regulation of health products. Digital health is also of focus in these modules.
“We are currently focussing on silos, especially when regulators don’t communicate with each other. But in fact, we need to create new platforms for the players across the whole environment, communicating and learning together.” Said Professor John Lim.
“There needs to be support creation and collaboration, as well as convergence. Respective jurisdictions and organizations need convergence across jurisdictions.”
This article was derived from the panel discussion, “The Future of Regulatory Policies for Digital Health in APAC” held during the APACMed Virtual 2020 Conference in September 2020.
- Accenture, Digital Health Technology Vision 2020, (July, 2020). Retrieved from: https://www.accenture.com/_acnmedia/PDF-130/Accenture-Health-Tech-Vision-2020.pdf#zoom=40
- Health Sciences Authority, Singapore, Regulatory Guidelines for Software Medical Devices – A Lifecycle Approach. (December 2019). Retrieved from: https://www.hsa.gov.sg/docs/default-source/announcements/regulatory-updates/regulatory-guidelines-for-software-medical-devices--a-lifecycle-approach.pdf
- Australian Government, Department of Health, Therapeutic Goods Administration. Regulation of Software as a Medical Device. (July 23, 2020). Retrieved from: https://www.tga.gov.au/regulation-software-medical-device