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The US Federal Trade Commission (FTC) has issued a statement on the Health Breach Notification Rule, providing clarification on which parties bear responsibility when there is a data breach in health apps and other connected devices.
According to a statement from the agency, the rule ensures that entities not covered by the Health insurance Portability and Accountability Act (HIPAA) still face consequences when health data is compromised. It requires vendors of personal health records (PHR) and PHR-related entities must notify consumers and the FTC, and possibly the media, if unsecured identifiable health information is breached or face civil penalties. It also covers these entities’ service providers.
Simply put, the statement says those entities covered by the rule which have experienced breaches cannot hide this from the consumers who have trusted them with sensitive health information.
Issued more than a decade ago, the rule’s requirements with respect to health apps and connected devices are more important than ever with the explosion in their use. While the FTC has advised mobile health app to examine their obligations under the rule, the agency has never enforced it and many entities appear to misunderstand its requirements, according to the statement.
The statement goes on to explain that the rule is triggered when a vendor of PHR with individually identifiable health information created or received by a healthcare provider experiences a breach of security. These breaches are not limited to cybersecurity intrusions or nefarious actions. Incidents of unauthorized access, including sharing of covered information without the individual’s consent, triggers the notification obligation of the rule.
The COVID-19 pandemic has exposed the cybersecurity gaps of many healthcare organizations and saw an increase in attacks from bad actors.
Some tips to keep your practice safe include: