This blog post is our 'Behind the Paper' on Modernizing and designing evaluation frameworks for connected sensor technologies in medicine, which was published on March 13, 2020.
As the COVID-19 outbreak continues to rage on, healthcare practitioners and researchers are searching for better options to provide quality care and research for patients who are travel-constrained and urged to stay at home.
Over the past two weeks, the FDA has released a number of guidances, including one on how to support existing clinical trials by easing restrictions around virtual visits and remote data collection and another on the FDA’s enforcement policy for remote monitoring for both routine care and triage of potential COVID-19 patients.
As we have seen over the past several weeks, connected sensors are quickly transforming telehealth, clinical research, and population health surveillance. For telehealth, providers are bolstering video calls by measuring biometric and phenotypic signals to support both triage and patient care. Existing clinical studies are shifting some site visits to be virtual visits, protecting participants and clinical sites. Population health surveillance systems are using connected sensors at home to identify potential hot spots of flu-like symptoms.
In this manuscript we outline evaluation frameworks for connected sensor technologies used to measure health. For each element of the framework, we propose potential thresholds to inform decisions. We drafted this framework before the COVID-19 outbreak, and recognize the assessment of risks and benefits of these technologies may shift as, for example, the need for remote monitoring becomes more acute.
The risks and benefits of connected sensor technologies can be significant. Thoughtful assessment and intentional decision making, even in a time of global health crisis, is essential. We do not have to look far to find historical examples of hastily assembled (and likely insecure) technologies outliving the crisis they were deployed to mitigate.
In our manuscript we provide resources, evaluation criteria, and target thresholds for five dimensions of (1) verification, analytical validation, and clinical validation (‘V3’), (2) security, (3) data rights and governance, (4) utility and usability, and (5) economic feasibility. Critically, we outline several pathways for operationalizing this framework, including potential methods to communicate the evaluation process.
To battle the current pandemic, this resource may be immediately valuable to clinicians and health systems managing patients remotely for the first time, as well as for industry sponsors of clinical trials aiming to keep their trials functional through the pandemic. For connected sensors, wearables, and other non-invasive remote measurement tools, it is critical to ensure that the tools deployed in the field are secure, affordable, easy-to-use, and evidence-based.
Our aspiration is that regulators, providers, and researchers will adopt and build on the five dimensions described in our manuscript, developing more robust thresholds and processes over time. This will provide guardrails to ensure that technologies come to market that are worthy of the trust society places in them.
Acknowledgements: Many thanks to my co-authors of Modernizing and designing evaluation frameworks for connected sensor technologies in medicine - Megan Doerr, Jennifer Goldsack, Christine Manta, Mark Shervey, Beau Woods & William A. Wood- also to Priyanka Agarwal, Dena Mendelsohn, and Adam Conner-Simons for reviewing and commenting on this post. Many thanks to Michael Henning for creating the headline graphic and to Indicius for the figure.