The Federal Trade Commission on 15th September authorized a policy statement reminding makers of health applications and linked devices that gather health-related data to follow a ten-year-old data breach notification rule. The regulation is part of the agency's push toward more robust technology enforcement under Chair Lina Khan, who hinted that more scrutiny of data-based ecosystems related to such apps and devices could be on the way.
In written remarks, Chair Lina Khan stated, "The Commission will enforce this Rule with vigour." According to the FTC, the law applies to a range of vendors, as well as their third-party service providers, who are not covered by the HIPAA breach notification rule but are held liable when clients' sensitive health data is breached.
After being charged with studying and establishing strategies to protect health information as part of the American Recovery and Reinvestment Act in 2009, the FTC created the Health Breach Notification Rule.
The rule requires suppliers of personal health records and PHR-related companies to notify U.S. consumers and the FTC when unsecured identifiable health information is breached, or risk civil penalties, according to the FTC. "In practical terms, this means that entities covered by the Rule who have experienced breaches cannot conceal this fact from those who have entrusted them with sensitive health information," the FTC says.
Since the rule's inception, there has been a proliferation of apps for tracking anything from fertility and menstruation to mental health, as well as linked gadgets that collect health-related data, such as fitness trackers.
The FTC's warning comes after the agency and fertility mobile app maker Flo Health reached an agreement in June over data-sharing privacy concerns. According to the FTC, the start-up company misled millions of women about how it shared their sensitive health data with third-party analytics firms like Facebook and Google, in violation of the FTC Act.
According to privacy attorney Kirk Nahra of the law firm WilmerHale, the FTC's actions on the Health Breach Notification Rule "are an interesting endeavour to widen how that rule has been understood since it was implemented."
"It is focusing attention on a much larger group of health-related companies, and changing how the FTC has looked at that rule and how the industry has perceived it. I expect meaningful challenges to this 'clarification' if it is put into play," he notes.
Failure to comply might result in "monetary penalties of up to $43,792 per violation per day," according to the new policy statement.