Lexology May 24, 2024
Whether life sciences and wellness companies have developed a product for consumers or created an online service, they may have to comply with the FTC’s recently finalized changes to the Health Breach Notification Rule (HBNR). HBNR applies to medical products and services as well as health and wellness products to the extent that they collect identifiable health data (e.g. device identifier + heart rate) at the direction of a consumer. However, it is not enough for the products or services to simply collect health data, they must allow consumers to upload that health data with an online service (e.g. app or website). This application of HBNR should come as no surprise to those following the FTC’s enforcement; however, to the...