Group wants to demystify regulations on digital health products

It is no secret that the Covid-19 pandemic has increased the pressure on already overstretched healthcare systems globally. Yet patients and providers alike are confused and wary of the opportunities – as well as the challenges – that lie ahead as digital technologies advance in this universe. While they promise to help make care more accessible and effective, such technological resources cannot and should not operate without regulation.

Thinking of demystifying regulatory processes, a group led by the Digital Medicine Society (DiMe), including Google, the US Food and Drug Administration (FDA) and the Harvard-MIT Center for Regulatory Science, has launched a collaborative initiative to create tools to help address regulation in the field of so-called digital health.

The project’s main objective is to support innovators who are looking for more effective regulatory strategies for developing reliable, high-quality digital products from both a patient and business perspective. In a recent survey among the digital medicine community, DiMe found that 25% of developers did not know if their digital health product should be regulated. Of those respondents who did have this knowledge, 75% reported not knowing the optimal regulatory pathway.

“We need to flip the order and start seeing regulatory strategy as a differentiator for digital health solution providers. There is likely to be a reduction in funding for digital innovators, so it is very important to select good regulatory pathways for products to ensure market access, trust and rapid adoption,” explains Jennifer Goldsack, Director at DiMe. “We are proud to work alongside industry leaders and regulatory members to ensure clarity and structure for innovators looking for easier regulatory pathways to position their products to rapidly improve the delivery of healthcare services to patients.

In the coming months, DiMe and its partners will create an interactive, open-access, regulatory support tool based on documents from the FDA and other agencies. The project aims to address a broad set of digital products for healthcare services, such as clinical decision support systems, digital diagnostic and therapeutic and remote monitoring technologies.  

According to DiMe, the tool and complementary resources, which will be publicly available in early 2023, are just part of the work to support the broad uptake of digital health tools and the optimisation of regulatory strategies.

DiMe has a robust track record of regulatory success, including a joint initiative with the German Ministry of Health to promote health apps and innovation priorities for real-world evidence generation. The collaborative work, published in The Lancet Digital Health, highlights best practices and a roadmap for ongoing methodological advances needed to accelerate digital medical innovation.

Opportunities and barriers

The global digital therapy (DTx) market is expected to exhibit a combined annual growth rate of 34.6% between 2022 and 2027, reaching a value of US$ 14.4 billion by 2027. By 2022, this market is expected to be valued at US$3.26 billion. One of the major causes that will drive the growth of the DTx market is the growing elderly population in the world, with obesity, cancer, and diabetes being the most common ailments among people over the age of 60, which will increase the demand for digital therapies.

However, a study warns that the growth rate of this market will be slowed by the lack of understanding of the technology involved with digital therapies in developing and low- or middle-income countries. Moreover, lack of research and development funds and expertise in these areas will further restrict market expansion. Data privacy concerns are another barrier that will impede the growth of the digital therapies market during the forecast period.

On the other hand, the growing awareness about the importance of self-monitoring and self-diagnosis of diseases may contribute to the growth of a particular segment of the healthcare market, home diagnostics. This global market, which was valued at US$4.78 billion in 2017, is expected to reach US$6.53 billion by 2025, with a compound annual growth rate of 3.98% over the forecast period between 2018 and 2025, according to the report published by Fior Markets.