Evidence Framework​ for Digital Health

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As 2019 comes to a close, digital health ends the year with more funding and a deepening utilization in health care. Thousands of apps exist with a preponderance in mental health, diabetes, and obesity. New clinical solutions are emerging daily and if they are to add value to health care the evidence base to determine efficacy and effectiveness needs to mature. A new framework released by the UK’s National Institute of Health and Care Excellence (NICE) proposes a methodology to appraise digital health technology (DHT). These technologies encompass wearables, apps, and algorithms.

The NICE framework proposes three tiers of evidence, and they are cumulative so each tier must be met to fulfill requirements for that level of evidence. Tier one consists of DHTs that operate at a systems level, and provide services for the health and social sector but don’t have any patient-related outcomes like electronic health records (EHR). Tier two has three subcomponents, inform, simple monitoring and communicate. Inform considers DHTs that deliver data to individuals and clinicians that may be either condition specific or relate to general health and well-being like apps that include recipes for healthy living. Simple monitoring includes fitness wearables and simple diaries, and the last subset is communicate which allows for 2-way communication between individuals and health care professionals. Tier three has two levels, 3a includes DHTs that support prevention and behavior change, like sleep, activity, sexual health and alcohol use. Self-management is also part of this grouping and consists of DHTs that support someones’ self-monitoring with reminders and supports to manage conditions. 3b has four subcomponents that include treat, active monitoring, calculate and diagnose, all having embedded guidance to support care and treatment decisions. 3b may also be at the first line of regulation as it has the closest links to care delivery by function, however, if DHTs are penetrating care models all will have to demonstrate value to health care systems like the National Health Services (NHS) in the UK and health systems in the USA and beyond.

Published Evidence in the time of Non-disclosure Agreements

One of the hallmarks of this framework is the need to published evidence. Since this space is nascent, this framework guides tech companies regarding the expectations countries and health systems will expect in the coming years. For the moment many companies have interested parties sign non-disclosure agreements before transparency emerges, balancing the tension of intellectual property with open sharing of how the solution works will be a necessary milestone for DHTs to meet.

Clinically Validated Tools and Engagement

From my experience, many apps in the mental health and wellness space are already embedding clinically validated tools into apps, and the challenge is holding the user experience as a north star while collecting clinically useful information. Often these tools sound clinical and academic, and consumers don’t always understand what they are being asked. Companies who can hold the line on the validity of administering these tools engagingly will have a distinct advantage, and the win-win of better data and the engaged user is essential for all parties.

It will be interesting to see if this framework gains traction with DHTs- in a sense they must as NICE is such a significant body in UK healthcare via the NHS. Will the USA follow suit and which entity will address this issue? Two thousand nineteen will bring a lot of significant developments to the forefront.

Thanks for reading – Trina
(Opinions are my own)



NICE evidence-based framework

Click to access digital-evidence-standards-framework.pdf




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