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

Employers that sponsor group health plans (medical, dental, vision, HFSA) are used to negotiating detailed administrative services agreements with vendors that provide services to those plans. Many also are familiar with “business associate agreements” required under HIPAA that must be in place with certain vendors, such as third-party claims administrators (TPAs), wellness program vendors, benefits

Many health care providers, including small and medium-sized physician practices, rely on a number of third party service providers to serve their patients and run their businesses. Perhaps the most important of these is a practice’s electronic medical record (EMR) provider, which manages and stores patient protected health information. EMR providers generally are business associates

Secretary Tom Price of the U.S. Department of Health and Human Services (HHS) announced his agency needs “to focus more on the most recent breaches and clarify when entities have taken action to resolve the issues that might have led to their breaches.” Accordingly, HHS’ Office of Civil Rights has launched a revised web tool

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

In honor of Data Privacy Day, we provide the following “Top 10 for 2016.”  While the list is by no means exhaustive, it does provide some hot topics for organizations to consider in 2016.

  1. EU/U.S. Data Transfer (status of Safe Harbor).  On October 6, 2015, the Court of Justice of the European Union (CJEU) ruled

Since mid-2013, the Department of Health and Human Services has recovered more than $10 million from numerous entities in connection with alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”).  However, during a recent American Bar Association conference, Jerome B. Meites, a chief regional civil rights counsel at the Department of Health and

Skagit County, Washington, has agreed to settle potential violations of the privacy and security rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), according to an announcement by the Office for Civil Rights (OCR) on Friday.  OCR reported that Skagit County, home to approximately 118,000 residents, agreed to a $215,000 monetary

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

The Department of Health and Human Services announced on February 24 that it is seeking information about conducting a pre-audit survey. That is, it plans to conduct a “survey of up to 1200 [HIPAA] covered entities (health plans, health care clearinghouses, and certain health care providers) and business associates (entities that provider certain services to