New approaches to evaluate digital solutions with clinical value

• Evidence required for digital health solutions that claim a clinical benefit and require regulatory approval is complex and differs from the evidence needed for drug therapies
• Digital health companies need to cultivate an innovative yet pragmatic evidence generation culture
• Leveraging data generation methods such as clinical simulation, observational studies using real-world data, and platform trials will help accelerate the impact of quality digital health solutions

Robust evidence generation is key to effective digital transformation in healthcare. Taking the required steps to enable and promote strong evidence will benefit all stakeholders in digital health, and above all will benefit the patients served (directly or indirectly) by digital solutions. This is particularly the case for the subset of digital health solutions that claim a clinical impact, like Software as a Medical Device (SaMD) as termed in the US, Medical Device Software (MDSW) as termed in the EU, and/or digital therapeutics.

For these types of digital health solutions, evaluations of safety and clinical efficacy will be required to support any necessary regulatory certification.¹ Assuming this approval is achieved, evidence supporting the value that the digital health solution offers is also likely to be important in subsequent efforts to commercialize a solution and encourage its adoption by healthcare professionals and organizations.¹

To learn more about the types of evidence that demonstrate the value of digital health solutions, download our free white paper below.

During the early product development stage of a digital health solution, there is a range of methods including qualitative studies (e.g. interviews, focus groups), secondary research (e.g. analyzing a clinical pathway or health system), and usability testing, which allow developers to adapt before moving forward with a minimum viable product (MVP).

These activities produce weaker evidence than traditional drug development studies, and although they may persuade a few “early adopters”, the majority of intended users expect more rigorous evaluations.

The acceptance of new approaches to evidence generation – such as real-world evidence (RWE), pragmatic trials, and simulation methods – will help to bridge the widespread evidence gap that exists, and support the wider adoption of effective solutions into healthcare systems.

Both molecules and algorithms now represent safe and effective treatments for disease, and regulators may apply the same standards to both. Yet software is fundamentally different from drugs and simple medical devices. Some of the differences include¹:

• Drugs interact with the human body to change how it functions, which leads to an improved outcome. 
• Digital health solutions interact with the health system and the human actors that operate within it (ie. patients, caregivers, and healthcare professionals) to change their behavior, which leads to an improved outcome.  
• Drugs themselves do not change during or after clinical trials, or once they have entered the market – the molecular composition is a constant. 
• Digital health solutions may continuously evolve and improve thanks to product improvements, additional features, and bug fixes. For these solutions, there is the opportunity to collect continuous evidence to improve and iterate on the product over time. 
• Drugs must demonstrate a meaningful benefit for regulatory approval, requiring a highly controlled and regulated set of clinical trials with thousands of patients before being implemented into a health system. Over many years, these studies aim to conclusively show that the medicine is safe and effective for use on the target population.
• Evidence of safety and value is also required for digital health solutions, but real-world evidence (RWE) is often deemed sufficient because they don’t impact the body itself.^2,3,4

Given these differences, treating digital health solutions that claim clinical value and traditional therapeutic interventions, in the same way, is a suboptimal approach. A middle ground must be found between two somewhat opposing traditions: rigorous clinical trials in healthcare and agile software development in the tech world.

Generating evidence for digital health solutions is a unique and challenging task, and it requires innovative thinking to accelerate the impact of these solutions. This will require an innovative yet pragmatic evidence-generation culture, leveraging methods such as clinical simulation, observational studies using real-world data (RWD), and platform trials (PTs).¹

• Simulation studies allow innovators to evaluate new digital products and services in a safe, efficient, and cost-effective manner before deploying them into the real world.

• Observational studies utilizing real-world data (RWD) generated by the digital solution itself can be used to build a strong evidence base for a solution, both during early pilot studies and on an ongoing basis in post-market surveillance. The evidence required for digital health solutions is different from that of drugs, and real-world evidence is often sufficient.

• Platform trials (PTs) are an adaptive type of clinical trial that aims to determine the best intervention for a disease. These may be useful for the evaluation of quickly evolving digital health solutions, because they are designed to be adaptive, allowing for interventions to be modified, or changed completely, over time.

As the field of digital health continues to mature, we can expect to see an increase in innovative methods to generate evidence, and regulators and healthcare providers will begin to trust and integrate digital health solutions into their services.

Innovative methods to demonstrate the benefits of digital health¹

For technology to truly transform healthcare, the health and life science industry needs to fully accept the change that accompanies convergence with the inherently agile world of technology. This means blending these capabilities and cultures with their existing expertise in the long and highly complex journey to discover, develop, and secure regulatory approval for medicines.

While many industries have already fully embraced digital, healthcare is still in the process of catching up. And yet, the healthcare industry is uniquely positioned to capitalize on digital health. This is because these companies already have existing relationships with key stakeholders and patients; already have a presence in key settings of care; already have a deep understanding of the healthcare system; and can leverage their existing portfolio to position digital solutions.

The COVID-19 pandemic brought the opportunity presented by the technology revolution to the forefront, and many healthcare leaders are taking steps to actively embrace it. This is the chance to move from pilots and experimentation to widespread adoption and transformation. Doing so will require us to examine our longstanding healthcare delivery models and find ways to integrate and leverage technology to provide better outcomes. By using digital technology to design new products, or to redefine the customer or user experiences, we can ultimately help deliver care in a better, more effective, and more efficient way.