Digital health solutions are rapidly growing and have the potential to revolutionize healthcare. A rising number of companies and increasing investment in digital health have marked the past decade. 1,2
There has been an explosion of digital products in healthcare which are not backed by any rigorous analysis of their safety, efficacy and value to patients or health systems. Digital health companies should be able to demonstrate the benefit of their solutions to ensure they deliver promised advantages to patients, clinicians and health systems. There are two broad areas of evidence — evidence of safety and efficacy, and evidence of value. The four areas assessed for value are clinical, financial, operational and experience.
Digital health solutions have changed how we operate and deliver value, mainly because there are more efficiencies gained from being faster.
Dr. Nam Tran at University of California
Traditional research methodologies, such as randomized clinical trials (RCTs), are ill-suited to digital health solutions. RCTs require large amounts of time, money and resources, while strict inclusion criteria for who can participate may not reflect the diversity of people targeted to use new technology. In addition, the rapid cycle of software solution updates requires similarly dynamic evidence generation.3
Evidence generation can be very expensive. In most markets, reimbursement pathways that reward good evidence do not exist, so manufacturers often have too little incentive to make this investment. However, slowdowns in digital health funding mean investors look for more from innovators, including stronger evidence to demonstrate clinical benefits, indicating ROI for economic buyers.3
Innovators do not know what types of evidence they should pursue. In many cases, there is a lack of clear information on evidence requirements from gatekeepers such as regulators and payors.3
Poor digital health literacy among patients and healthcare professionals is a significant hurdle to improved evidence generation and the wider adoption of digital health solutions.3
Innovators often don’t have access to data that would help generate strong evidence for their solutions nor the capacity to gather and store it securely. Poor interoperability, siloed data architectures and incoherent data policy between regions all limit progress in this area.3
Watch keynote speaker Dr. Simon Mathews, assistant professor of medicine at Johns Hopkins Medicine and thought leader for improving care delivery and value through technology, explain this topic.
Drive efficiencies, raise health equity, enable value based care
A wide variety of technologies — medical apps, clinical decision support software, electronic health records, telehealth, health information technology, wearables devices, artificial intelligence and machine learning — can be considered digital health solutions. These solutions have the potential to improve health access, outcomes and equity as well as operational efficiency and costs for healthcare organizations.5
There is huge diversity among digital tools. It is critical that evidence requirements are stratified based on intended purpose. Several countries have made progress in establishing evidence standards that take this into account. Generally, clinical evidence of safety, risk assessment, technical documentation and security and data standards are necessary for regulatory approval. But it is crucial that all stakeholders in the digital health field work together with policymakers and regulators to ensure the level of evidence expected for different types of solutions in regulation is robust and sensible.3
Software is fundamentally different from drugs and simple medical devices, and treating it in the same way as those interventions is a suboptimal approach. Most types of evidence can be generated at various stages of the product life cycle. Innovators must understand how to iterate rapidly in the early stages and make adaptations before moving forward with a more defined product, requiring more rigorous assessment. It remains a challenge to generate robust evidence for many digital health solutions in a timely and cost-effective manner.
In many markets, the routes to reimbursement for digital solutions remain unclear. In most markets, there is no effective and efficient route to national scale for innovators. Industry needs better opportunities with payors, greater awareness among healthcare professionals about digital solutions and guidance aligned with evidentiary standards to drive increased prescription and reimbursement of these tools.3
For a list of reimbursement pathways in four leading markets, please download our PDF.
A digital health solution with a medical purpose such as disease detection, prevention or management qualifies as a medical device. In the US, digital health solutions categorized as Software as a Medical Device must be approved by the Food & Drug Administration to be prescribed or otherwise adopted. In the EU, Medical Device Software is subject to regulation.
References & notes
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