CTA for data sharing
In this Heart Rhythm article, you'll learn about:
- Patients are embracing the tools of digital health; therefore, it is incumbent that members of the medical team help guide and be supportive of this transition. Medical team members should discuss at the outset expectations for patients who wish to share data from their consumer wearable device with the team. This discussion should include the method by which the data will be communicated, expected frequency, the type of data, and expected response time from a team member.
- Regulatory agencies across the world recognize the importance of a unified paradigm for evaluating, approving, and monitoring the safety and effectiveness of medical devices. This is particularly important for consumer devices that will cross international boundaries. The International Medical Device Regulators Forum has been established to meet this need.
- Clinical team members appreciate the value of consumer wearable devices but have concerns that important and fundamental components of how the data are communicated and stored remain unresolved. They are also concerned that some individuals may inundate a practice by overutilizing the technology. Finally, reimbursement must be established commensurate with the burden and risk assumed by the provider.