eveloping and commercializing digital health technology (DHT) is a truly multidisciplinary undertaking. “Multiple stakeholders are involved” as the somewhat clichéd saying goes. Like more traditional drug development and clinical diagnostic tools, DHTs have wide-ranging applications, but a feature that sets them apart is the more prominent involvement of the patient (consumer). Does that mean that these “end users” are by default the most important stakeholders during DHT design and development? They should be, but it often depends on the specific incentive for developing the DHT in the first place.

One way or another, contemporary pharmaceutical companies are involved in digital health programs. Consequently, they have an important voice in this space, as they interact with a plethora of DHT and service providers. However, pharma’s most common incentive is to use DHTs as drug development tools (DDT). In that context, the real needs of the patient quickly become secondary to the DDT, and this may be with good reason. One could argue that the ability to capture the “right data at the right time” to evaluate a promising new drug should be prioritized over potentially minor inconveniences for the study population (emphasis on “minor” though). We need to be mindful when pharma-driven incentives (drug development, strategic investments, companion diagnostics, to name just a few) become the core determinant for designing a DHT that is also intended for use beyond clinical research, as this can lead to a loss of attention to product features that are critically important to patients and healthcare professionals. Other types of strategic partnerships can suffer from the same pitfalls. When developing a DHT for clinical practice, patient-centric design principles are key to its success, as are socioeconomic, value-based, and physician-centric drivers, and who is setting those drivers.

How do we reconcile these different stakeholder drivers to ensure that, as a thriving community, we build DHTs for the right audience (i.e., fit-for-purpose)? That is a huge topic that organizations like the Digital Medicine Society (DiMe) are trailblazing. For this piece, a more narrowly defined follow-up to that posit is: Can our community operate in a regulatory environment that acknowledges the existence of these drivers while encouraging patient-centricity and equitable use of technology?

In the US, the regulatory environment that deals with digital health and medicine is rapidly evolving and has a solid foundation. The recently launched FDA Digital Health Center of Excellence, industry guidance on the use of modern technology in medical devices, including software and artificial intelligence, as well as the use of DHTs that are not categorized as medical devices, are all helping to solidify this foundation further. Combine this with stalwart guidance on the qualification of DDTs and premarket submissions, and a proficient ecosystem is in place. Importantly, the aforementioned DiMe society, HealthXL, the Digital Therapeutics Alliance, Decentralized Trials and Research Alliance, to name just a few, provide complementary guidance and education, and rally the field around a well-defined set of incentives, including but not limited to patient-centricity and equity. Within this ecosystem, pathways are already in place to evaluate novel technology quickly and safely, as well as repurpose existing technology, in ways that are tailored for DDT, healthcare providers, direct-to-patient, or direct-to-consumer applications.

In the EU, an equally thriving ecosystem of DHT developers, users, and advocates is evolving, but several regulatory factors and recent changes are making the process less streamlined compared to its US counterpart. Although the new EU Medical Device Regulation (MDR, EU 2017/745) intends to harmonize member state regulations, it has led to a significant strain on the notified bodies and national competent authorities tasked with enforcing these regulations and country-specific laws, resulting in audit bottlenecks and delays for market entry authorizations. Additionally, the system of notified bodies leads to a “check the box” approach with a heavy reliance on international technical standards (e.g., International Electrotechnical Commission) that puts more emphasis on reaching somewhat arbitrary performance standards as opposed to a pragmatic definition of “fit-for-purposeness.” The onus is almost entirely on the manufacturer to interpret these checklists with a focus on quality, safety, and value. The fact that drug development-related work falls under the purview of the EMA, a separate organization, risks further fragmentation rather than collaboration. Finally, member state-driven systems to label and categorize modern medical devices, as well as nondevice health and wellness applications, are popping up rapidly. Examples are the German (DiGa) and Belgian mHealthBelgium initiatives. Although aspirational in nature, they may add to the fragmentation by using their own definitions and interpretations of the regulatory, research, and clinical contexts. Ensuring that the EU regulatory environment is and remains supportive of novel DHTs will take time. Considering lessons learned from the EU and US regulatory environments should help us streamline paths to market without adding any undue red tape.

Everyone directly or indirectly involved in developing DHTs should be continuously mindful of their intended end user, patients, and healthcare providers alike, especially in the context of DDT vs. clinical care or even hybrid applications. The fact that the digital health community is so vibrant, both in the US and EU, is an enormous asset, but it also generates complex incentives that are not always straightforward to interpret and manage, let alone align with an international regulatory strategy.