Last week, the Federal Trade Commission (FTC) announced in a Statement of the Commission On Breaches by Health Apps and Other Connected Devices (Policy Statement) that the FTC will begin enforcement of its Health Breach Notification Rule (Rule) issued in 2009. The Rule was issued by the FTC to regulate certain businesses that handle health information when they are not regulated by the Health Insurance Portability and Accountability Act (HIPAA). Many of those businesses are likely not aware of the Rule, because there has been no public enforcement activity. While questions about the Rule’s scope remain, recent actions by the FTC (including the Policy Statement) suggest that it may be time for businesses to consider whether and how their operations may be drawing interest (investigative and enforcement) from regulators.
Persistent uncertainty about the scope of the FTC’s Health Breach Notification Rule
Our colleagues wrote about the Rule when it was first issued, to explain how certain businesses that handle health information may be required by the Rule to provide notice of data breaches affecting health information. We will not restate that analysis here, but it remains as accurate now as it was then. Until last week, the FTC had never publicly enforced or published new guidance on the Rule. Significant questions, therefore persist, about how the FTC will interpret and apply the Rule.
The Rule does not apply to businesses regulated by HIPAA, but the Rule ambiguously describes the types of business to which it does apply. For example, as drafted, employers that hold employee health records electronically could theoretically be regulated by the Rule—even though it was likely not the FTC’s intent for the Rule to apply in the employment context. Given the Rule’s ambiguous scope, businesses may need to conduct a case-by-case assessment of the applicability of the Rule to their data security incidents to avoid missing this little-known and broad regulatory requirement.
In contrast with the FTC’s Health Breach Notification Rule, HIPAA, which is enforced by the Office for Civil Rights in the Department of Health and Human Services, generally provides clear guidelines as to the scope of its applicability. HIPAA is applicable only to health care providers that submit claims electronically, health plans, and health care clearinghouses. Similar to the Rule, a breach of unsecured protected health information regulated by HIPAA triggers potential breach notification requirements. A “breach” under HIPAA involves “an acquisition, access, use, or disclosure of protected health information in a manner not permitted” by HIPAA, which includes many restrictions on disclosures without patient authorization. Failure to comply with the notification requirements under HIPAA could result in civil monetary and other penalties.