The Federal Trade Commission (FTC) has taken a significant stride in bolstering consumer protection in the digital health realm with its recent overhaul of the Health Breach Notification Rule (HBNR). Now, health apps and analogous technologies are brought under stringent scrutiny, filling a regulatory void that previously left them outside the scope of existing legislation like HIPAA. Under the revamped regulations, entities not covered by HIPAA, such as vendors of personal health records (PHR) and related entities, are mandated to promptly notify individuals, the FTC, and potentially the media in the event of a breach of unsecured personally identifiable health…
Author: Navneet S
UnitedHealth Group has just announced the closure of its Optum Virtual Care telehealth business, signaling a shift within the company’s healthcare delivery model. Employees were informed of this decision last Thursday (April 18), with some being notified that their last day with the company would be in July, as reported by Seeking Alpha referencing Endpoints News. Upon reaching out for clarification, a spokesperson for UnitedHealth Group responded by highlighting the organization’s commitment to supporting affected team members during this transition. The company aims to provide job placement resources and is exploring opportunities to deploy individuals into available roles within the…
Food and Drug Administration (FDA) has approved the first-ever “prescription digital therapeutic” smartphone app, Rejoyn, designed to aid in the treatment of major depressive disorder (MDD). Developed by Otsuka America Pharmaceutical, Rejoyn is intended to be used alongside traditional antidepressant medication and talk therapy, serving as an innovative adjunctive treatment for individuals struggling with MDD symptoms. Dr. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, expressed enthusiasm about this milestone in mental health care. He emphasized that Rejoyn represents a promising additional treatment option that complements the current standard of care for MDD, highlighting its potential impact…
In a groundbreaking development, researchers at the U.S. National Institutes of Health (NIH) have leveraged artificial intelligence (AI) to revolutionize the imaging of cells within the eye. This pioneering work promises to significantly enhance our ability to diagnose and understand retinal diseases such as age-related macular degeneration. According to NIH, the application of AI has yielded remarkable improvements in imaging efficiency and clarity. The research team reported that with AI integration, imaging has accelerated by a remarkable factor of 100, while image contrast has been enhanced by 3.5-fold. These advancements represent a critical leap forward in the field of ophthalmic…
Neurovalens, a pioneering neurotechnology startup based in Belfast, has achieved a significant milestone with the recent clearance of its second head-mounted medical device by the U.S. Food and Drug Administration (FDA). This clearance marks a key advancement in the company’s mission to provide innovative noninvasive treatments for various neurological and metabolic conditions. The FDA’s approval allows Neurovalens to offer two prescription-based devices for specific medical conditions in the United States: one targeting generalized anxiety disorder (GAD) and the other addressing insomnia. These devices utilize noninvasive electrical stimulation of the brain and nervous system to deliver therapeutic effects. The GAD device…