U.S. Department of Health and Human Services

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created 12-month post in which Fu will “work to bridge the gap between medicine and computer science and help manufacturers protect

Over the past few years, and particularly during the COVID-19 pandemic, the Department of Health and Human Services Office for Civil Rights in Action (OCR) has made countless efforts to enhance its Health Insurance Portability and Accountability Act (HIPAA) guidance and other related resources on its website. Last week, the OCR launched a new feature

HIPAA: Second Settlement this Year Related to Right to Access Initiative | Blogs | Health Care Law Today | Foley & Lardner LLPWhen providers, health plans, business associates, and even patients and plan participants think of the HIPAA privacy and security rules (‘HIPAA Rules”), they seem to be more focused on the privacy and security aspects of the HIPAA Rules. That is, for example, safeguarding an individual’s protected health information (PHI) to avoid data breaches or avoiding

The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) wants to make it easier for individuals to reach a healthcare provider, including those most at risk (older persons and persons with disabilities). Effective immediately, during the COVID-19 nationwide public health emergency, OCR announced it will not enforce noncompliance with

A recent report indicates that nearly 500,000 individual health records were breached in September 2017. This figure is taken from the 39 healthcare data breaches involving more than 500 records that were reported to the Department of Health and Human Services’ Office for Civil Rights in September 2017.  Healthcare providers suffered the most breaches with

As you likely know by now, international cybercriminals launched a worldwide ransomware attack last Friday with the European law enforcement agency Europol reporting over 100,000 affected organizations in 150 countries, including the U.S. Reports indicate that health care providers, universities, and other large companies were all targeted. The Department of Health and Human Services also

The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”

The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors