Trust is key
Guaranteeing the privacy of wearable data involves securing that data on the device, over networks, and on their services—and it may require being transparent about which other entities have access to that data. At present, consumer wearable companies are not bound by the Health Insurance Portability and Accountability Act (HIPAA) governing how patient data is secured and shared among medical systems in the United States. However, if consumer wearables move closer to health data and analysis, they could provoke a regulatory response.
Securing wearable data is important but how good is the data itself? Although wearables are increasingly gaining some degree of clearance or approval by the FDA,5 doctors may dismiss the data since consumer wearable companies are not held to the kinds of safety and liability standards that medical providers are.6 For medical devices, clinical trials and strong regulatory oversight guarantee the data’s quality and validity as well as the process’s transparency and compliance. Data from smartwatches and health and fitness trackers does not usually have the same oversight.
These challenges reinforce the gap between consumer wearables that may offer directional advice, and the clinical practitioners providing regulated medical outcomes. The risk is that consumer wearables for health could become an alternative system of companies pushing further into measuring medical data without needing to provide protections or transparency. Device makers, health care professionals, and regulators have a significant opportunity to avoid this scenario by aligning on integrating wearables into a holistic, data-driven health ecosystem that prioritizes prevention and early detection.7 Additionally, stronger partnerships could improve algorithms, realize greater value of the data, and deliver better insights supporting health and wellness for people and practitioners. All of this can foster more trust from consumers being asked to trade their data for wellness.
Implications for executives
There are many devices and services available to consumers, driving a fragmented landscape with no clear requirements for sensors, data capture, validation, privacy, or security. Consumer wearable makers that are moving into health should consider the following to help ensure their success:
• The device is one part of a data ecosystem that could likely fall under HIPAA regulations at some point. To get ahead of this likelihood, consumer wearable companies should prioritize data security and privacy—on the device, over networks, and on service infrastructure. Focusing on these criteria can lay the foundation for building enduring trust.
• Additionally, the reliability and accuracy of data should be better guaranteed. Does the data generated meet the requirements for clinical use? If not, what are the factors keeping the device from compliance—and can those factors be overcome? Device makers should more closely align with health care providers to make the data more valuable to clinical outcomes.
• Consumer wearable companies pursuing medical data should embrace health care as a partner toward a more integrated, data-driven health care ecosystem than can accrue benefits to all parties—and reinforce the value and insights in the data that users are willing to share. Health care providers should reciprocate, leveraging that data as a mutually accessible input into patients’ own tracking and maintenance of their health and well-being.
As health care shifts to a patient-centric model, consumer health wearables can play a central role in prevention and care while laying the foundation for the future of health8—in which care leverages data to support preventive approaches and overall patient wellness. But until device makers can guarantee data validity and user privacy, consumer wearables will likely face concerns from users and skepticism from medical professionals.