Wearable Technology & Regulation Gaps

By Soniya Shah

With the advent of wearables like smart watches and fitness trackers becoming more popular by the day, we have some big questions to answer around data privacy and security. There is always concern about new technology and cyber attacks, especially when data travels through wireless networks. 

Users of these devices usually do not want others looking at their data, especially when it comes to health data. However, many privacy policies are vague and even include disclaimers that information may be shared with third parties. Part of the issue is that HIPPA does not extend to this medical information, so makers of wearables legally can share medical data without incurring liability. 

Wearables obtain Information about a person including the time and duration of activity. This information coupled with demographic user profiles can provide data that is crucial to businesses looking to market to individual consumers. 

The security of this information is important because identifying individuals based on their data poses security and privacy risks. For example, insurance companies could use the information to price differentiate between customers. Despite the potential risks, wearables have gone largely unregulated by the FDA, because traditional wearables do not assist in patient treatment, and the risk of wearing a device like an Apple Watch is low. 

While most wearables are not subject to federal regulation, states have the power to regulate via consumer protection laws and other state laws. For example, California has stricter privacy laws around medical data than what is mandated by HIPAA through federal regulations. States should consider tightening regulations to protect consumer data and alleviate some of the risks that come with wearable technology. 

In early June, Senators Amy Klobuchar and Lisa Murkowski introduced the Protecting Personal Health Data Act, which would put into place new privacy and security rules around devices that collect personal health data, including wearables like fitness trackers. The Act would require the Department of Health and Human Services (HHS) Secretary to issue regulations related to privacy and security of health-related consumer devices, applications, services, and software. The bill would incorporate concepts from the European Union’s General Data Protection Regulation (GDPR), such as individual access to delete and amend health data tracked through wearables and other applications. To implement the Act, HHS would need to create a national task force to address cybersecurity risks and privacy concerns. 

HHS will need to take into account the different standards needed for each type of data that is collected, including genetic and general personal health data. Perhaps more importantly will be the ability for consumers to access their own data and have more control over what is used and collected by companies. 

The Act is part of a larger Congressional effort to increase efforts to protect consumer privacy, especially after Facebook data scandals. While this Act could be a big step for privacy and security concerns, there are no guarantees the bill will pass. While we wait for federal regulation, it might be time for states to follow in California’s footsteps and start creating legislation that protects consumers. 

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