Monday, November 18, 2019

Congress Eyes Privacy Protections for Data on mHealth Wearables


A bill introduced this week - and another introduced this past June - aim to protect patient health data gathered on consumer-facing mHealth wearables like smartwatches, fitness bands and even apps.   
November 15, 2019 - Congress is jumping into the long-simmering debate over the protection of health data on consumer-facing mHealth wearables.
US Senators Bill Cassidy (R-LA) and Jacky Rosen (D-NV) have introduced a bill this week that aims to define how data gathered on smartwatches, fitness bands and other connected health devices – including mHealth apps - dis protected and prevent “entities that collect consumer health information” from exposing that data to other parties.
“The introduction of technology to our health care system in the form of apps and wearable health devices has brought up a number of important questions regarding data collection and privacy,” Rosen said in a press release announcing the bill, to be called The Stop Marketing And Revealing The Wearables And Trackers Consumer Health (SMARTWATCH) Data Act. “This commonsense, bipartisan legislation will extend existing health care privacy protections to personal health data collected by apps and wearables, preventing this data from being sold or used commercially without the consumer’s consent.” 
The bill’s introduction comes amidst a flurry of news in the consumer-facing mHealth arena, including Google’s pending purchase of Fitbit and the announcement that the tech giant will be working with Ascension – the largest non-profit health system in the US – to integrate mHealth technology and data collection into the health system’s care programs.
“The Google/Ascension news has brought needed scrutiny to the security of Americans’ health data,” Cassidy said in the press release. “The SMARTWATCH Act prevents big tech data harvesters from collecting intimate private data without patients’ consent. Americans should always know their health information is secure.”
The bill defines consumer health information as “any information about the health status, personal biometric information, or personal kinesthetic information (such as keystroke or gait patterns and sleep information) about a specific individual that is created or collected by a personal consumer device, whether detected from sensors or input manually.” This would include not only physiological, biological and behavioral data, but “deoxyribonucleic acid, imagery of the iris, retina, fingerprint, face, hand, palm, vein patterns, and voice recordings, from which an identifier template, such as a faceprint, a minutiae template, or a voiceprint, can be extracted.”
Under the bill, the organization that collects that data would be barred from transferring, selling, sharing or allowing access to that data, unless aggregated and anonymized, to “any domestic information broker or other domestic entity” whose primary function is to analyze that information for profit or whose primary purpose is to add commercial value to the entity collecting the data.
The bill goes on to direct the Health and Human Services Secretary to treat violations in the same way that it would treat HIPAA (Health and Insurance Portability and Accountability Act) violations.
The legislation mirrors a bill introduced in June by Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) that aims to protect consumer health information not protected under current laws.
The Protecting Personal Health Data Act (S.1842) would require the development of regulations that strengthen privacy and security protections, including setting consent standards that address genetic, biometric and general personal health data, and give consumers the ability to access, amend and delete their data. It would also create a National Task Force on Health Data Protection that would:
·         evaluate and provide input to address cybersecurity risks and privacy concerns associated with consumer products that handle personal health data, and the development of security standards for consumer devices, services, applications, and software; and
·         study the long-term effectiveness of de-identification methodologies for genetic and biometric data, and advise on the creation of resources to educate consumers about direct-to-consumer genetic testing.


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