There are lots of digital medicine tools available these days – online programs, apps, devices, and more. We’ve covered the growth in the treatment tech tools available out there – Fitting ‘Invisibles’ Into Your Tech Planning, Planning Your Treatment Tech Investment, and App Potential For Treatment Tech.
The issue for consumers and professionals alike is how to choose among the many options. There are issues of consumer usability (see When It Comes To Digital Health Tools, What Do Consumers Want? and Building Your Own Tech-Enabled Consumer Base). Issues with the paucity of scientific evidence – Consumer-Directed Therapies – Where Consumer Use Has Outpaced Science and More Than 3,000 Mental Health Apps Available For Download, Limited Number With Evidence Of Efficacy. And, issues with cost – Moving Tech From “Cost” To “Investment” and More Tools For Tech ROI.
As part of the solution to these issues, the U.S. Food and Drug Administration (FDA) is moving a step closer to determining the clinical value of apps and other software. A couple years ago we covered the FDA when it issued its final regulations for application developers, focusing at that time on medical apps intended as accessories to regulated medical devices and/or transform mobile platforms into regulated medical devices (see The Smartphone App Regulations Are Here). Now, the FDA is taking it a step farther to help determine the clinical value of apps and other software.
Last fall the FDA released draft guidelines to clarify the department’s position on mobile medical devices and mobile medical apps – specifically, the FDA announced it is developing requirements for “clinical algorithms referred to as software-as-a-medical device (SaMD) in order to establish principles for clinical evaluation of scientific validity, clinical performance, and analytical validity” (for a breakdown of the guidelines, see FDA Developing Requirements For Evaluation Of Tech-Enabled Clinical Algorithms).
In this case, the SaMD is not a device – just the algorithm that analyzes the data inputs and provides data output to a user to support clinical management. There are four broad SaMD categories:
- Informs non-serious and serious clinical management, and drives serious clinical management: A SaMD that analyzes images, movement of the eye or other information to guide next diagnostic action of astigmatism, and then provides clinical information that does not trigger immediate or near-term action to treat a condition that can be managed effectively would fall into this category.
- Informs critical and drives serious clinical management, and treats/diagnoses non-serious conditions: A SaMD that uses data from individuals for predicting risk score for developing stroke or heart disease for creating prevention or interventional strategies would fall into this category.
- Drives critical clinical management, and treats/diagnoses serious condition: A SaMD that is intended as a radiation treatment planning system as an aid in treatment in a critical condition that may be life threatening and requires major therapeutic intervention would fall into this category.
- Treats/diagnoses critical condition: A SaMd that performs analysis of cerebrospinal fluid spectroscopy data to diagnose 370 tuberculosis meningitis or viral meningitis in children would fall into this category.
The FDA describes this focus on clinical excellence as, “For all medical devices, clinical evaluation, a process activity that is conducted during a product’s lifecycle as part of the quality management system, is the assessment and analysis of clinical data pertaining to a medical device to verify its safety, effectiveness, and performance.”
For any stakeholder in the health and human service space – whether consumer, professional, tech supplier, health plan, or provider organization – the takeaway is that the focus on “scientific validity, analytical validity, and clinical performance” is the next drop in the trickle down from the value-based philosophy remaking the industry (see The Chain Continues – Value-Based Payment Moves To Devices & Pharma). While there is still not a lot of information available about the effectiveness of new technology tools, I expect that will change. And the focus of the FDA on clinical algorithms is timely as we move toward value-based reimbursement – which is heavily reliant on critical decisions about “best practice” for success.
For more on the impact of tech on the health and human services field, mark your calendar for September 21 at 1:00 pm (EST), when I will host a webinar exploring best practices for tech in a changing market exclusively for OPEN MINDS Circle Elite members – Forecasting The Future: What’s The Impact Of Health Care Technology For Consumers & The Service Delivery System. Not an Elite member? Upgrade your account now to access OPEN MINDS Market Intelligence Reports, the Government RFP & Contract Database, special registrations to all OPEN MINDS institutes, and exclusive online executive education events.