Explore how strategic mergers and acquisitions (M&A) can reduce or even eliminate point solution fatigue by creating more comprehensive and integrated platforms that will improve patient care and reduce administrative burden.
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The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule (HBNR), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.
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Last Friday, Colorado’s governor signed into law the Colorado AI Act (“CAIA”). For digital health companies building with artificial intelligence, CAIA sets the first comprehensive national benchmark for minimum rights and protections for users of healthcare AI, effective February 1, 2026.
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On January 13, 2022, in response to numerous legal challenges premised on the lack or abuse of executive authority.
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For the first time, the Drug Enforcement Agency (“DEA”) is becoming directly involved in the telepharmacy space, an industry that the DEA has not previously regulated aside from the loose application of its existing regulations governing online pharmacies. Find out what this means for your business and how you can submit comments to the DEA directly in this post.
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Dentistry is one of a number of clinical specialties that is taking a creative and innovative approach to delivering care using digital health tools. Most of us are now familiar with Byte, SmileDirectClub, and Candid—these companies are pioneers in the space. However, tele-dentistry has far more potential applications than retail clear aligner services. Tele-dentistry entrepreneurs are building solutions for remote examination of sore or swollen teeth and gums, screening for certain oral diseases and cancers, mobile dental hygiene, dental hygiene education, and more.
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The Centers for Medicare and Medicaid Services (CMS) issued its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) on November 4, 2021, the same day the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS). The IFR and ETS complement each other, with both aimed at furthering the Biden Administration’s goal of vaccinating the entire United States healthcare workforce to ensure capacity to serve local and national healthcare needs, the safety of the workforce and patients, and to reduce the risk of continued COVID-19 transmission. Both rules are effective November 5, 2021.
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If you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.
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