Healthcare providers, health plans, and technology companies that use mobile health apps to access, collect, share, use, or maintain information related to an individual’s health should take note of the […]
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation […]
Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations. […]
Digital Health Compliance Considerations — Revenue Models and Patient Incentives The digital health market continues to grow exponentially in the United States. As startups and established companies market digital tools […]
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number […]
In almost the first three quarters of 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) has settled three cases related to alleged violations of […]
New Annual HIPAA Penalty Tiers Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department of Health & Human Services’ Office […]
On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats […]
On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve […]
The Administration is preparing to release a Request for Information (“RFI”) on potential modifications to Health Insurance Portability and Accountability Act (HIPAA) rules. The draft RFI was recently submitted by […]