Prototype to Patient Treatment: Dialogue on Safety, Regulation, Privacy, Security, and Acceptability for Wearable Medical Devices — A Workshop ReportReport
Emerging technologies, such as wearable medical devices, can raise important societal concerns about regulation, privacy, safety, security, and acceptability. If left unresolved, these issues may stymie important technologies from reaching patients or result in unforeseen physical or emotional harms. It is not enough for early-stage research and development to generate fundamental knowledge and optimize technical operations without addressing societal issues, explicitly. Thus, organizations from across the medical device innovation ecosystem must work together to explore, deliberate, and negotiate topics that extend beyond technical functionality. Knowledge needs to be exchanged among these organizations about new technical capacities (and limitations) and societal needs (and constraints) for wearable medical devices to emerge and enhance human health and well-being.
The Engineering Research Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) is researching novel prototypes of wearable medical devices that support health monitoring and treatment delivery. ASSIST leaders recognized the need to go beyond technical research and to explore the broader societal issues of risk, regulation, safety, security, and acceptability. On October 25, 2016, ASSIST brought together experts from academic and industrial research, healthcare administration, and federal agencies to facilitate dialogue across the innovation ecosystem among stakeholders that too often remain ‘siloed’ and disconnected from one another. The workshops objectives were to identify, prioritize and make key recommendations to address the challenge areas of safety, regulation, privacy, security, and acceptability. The workshop was designed to spark creativity, generate empathy, elicit complex issues, and explore alternative solutions.
The workshop yielded three key outcomes, including:
1. Create an opportunity to collaborate in a low-risk setting and build relationships with others from disparate sectors and organizations.
2. Identify complex, cross-cutting, and inter-dependent issues associated with the development of wearable devices before prioritizing key issues and making recommendations for each challenge area.
3. Identify at least one key recommendation for each challenge area:
Security: Expand the Digital Millennium Copyright Act to include an exemption for medical devices, making it legal to reverse engineer and identify critical vulnerabilities in devices.
Safety: Systematically identify who is legally responsible for each specific aspect of a device’s functionality when wearable medical devices are integrated into patient care.
Acceptability: Funding agencies need to move beyond technical feasibility measures for success and incentivize integration of knowledge and preferences from users, patients, payers, caregivers, and ethicists.
Privacy: Acknowledge that ownership is multifaceted and reflect that in consent forms and policy documents, which need to be communicated in uniform, understandable language.
Regulation: Create a secondary mechanism (in parallel to Phase III FDA approval) for novel wearable devices to be reviewed and approved by Medicaid and Medicare payers for use by lower-income patients. This addresses the issue of ‘trickle down’ innovation where wealthy patient reap rewards from innovation far sooner than lower-income patients.
The ASSIST Center is now well-positioned to facilitate on-going dialogues that pursue the five cross-cutting topics among organizations involved in medical device innovation.
Wearable Medical Devices, Innovation Ecosystems, Governance
University of Virginia
October 25, 2017
National Science Foundation
This report is based upon work primarily supported by the National Science Foundation (NSF) with a supplemental award to NSF grant #1160483. The authors want to thank the work of six undergraduate research assistants (Loriana Demirciyan, Victoria Lindsey, Caitlin Mahoney, Jessica Preston, Emma Price, and Rachel Richardson), as well as the work of Ember Melcher and Melissa Ferrell that was essential to support the workshop. Further, we want to thank the participants for their willingness to engage and without their efforts, this would not be possible. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors, and do not necessarily reflect neither the views of the National Science Foundation nor the participants.