Health Law Advisor

Recently, the U.S. Department of Health & Human Services (“HHS”) issued guidance for healthcare cybersecurity best practices.  As required under the Cybersecurity Act (CSA) of 2015, this four-part guidance was generated by a Task Group charged with the following:

1. Examining current cybersecurity threats affecting the healthcare and public health sector;
2. Identifying specific weaknesses that make healthcare and public health organizations more vulnerable to cybersecurity threats; and
3. Providing certain practices that cybersecurity experts rank as most effective ...

On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.  This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions.  This guidance comes at a critical time as the healthcare industry is a prime target for hackers.  On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device ...

The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb, M.D., Commissioner of the FDA ...

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]

FDA regulates medical ...

According to a report by West Monroe Partners, approximately 40% of companies engaged in corporate transactions reported finding a cybersecurity issue during post-acquisition integration of the target company.  While companies routinely conduct robust transactional due diligence to manage legal risk, many fail to adequately conduct cybersecurity due diligence. As a consequence, many companies and investors are leaving themselves vulnerable to potentially severe latent cyber risks.

Cybersecurity is especially relevant in healthcare transactions as the industry ...

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”).  In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.

Breakthrough Device Program

The Breakthrough Device ...

As 2019 begins, companies should seriously consider the financial and reputational impacts of cyber incidents and invest in sufficient and appropriate cyber liability coverage. According to a recent published report, incidents of lost personal information (such as protected health information) are on the rise and are significantly costing companies. Although cyber liability insurance is not new, many companies lack sufficient coverage. RSM US LLP, NetDiligence 2018 Cyber Claims Study (2018).

According to the 2018 study, cyber claims are impacting companies of all sizes ...

In the November 2018 mid-term elections, state ballot measures for the legalization of marijuana were approved in three states – Michigan, Missouri, and Utah – and rejected in one state – North Dakota.

Michigan

Michigan is now the 10^th state in the country to legalize the recreational use of marijuana under certain conditions. Michigan residents approved Proposal 1, allowing for recreational marijuana to be consumed, purchased, or cultivated by those 21 and over. The new law went into effect December 6, 2018, but the commercial system will not be running for another year. The ...

Did you know that your zip code is a better predictor of your health than your genetic code? Public health experts – and your health insurance provider – have long known that the air you breath, the education you receive, your net worth, and even the music that you listen to are strong indicators of your overall health – and the possibility that you might need expensive medical procedures in the future. By some measures, up to 50% of your overall health is determined by social, economic, and environmental factors. As the movement to value-based payment continues in health care, there ...

Two recent federal cases illustrate why employers – even federal contractors – must be cognizant of relevant state-law pronouncements regarding the use of marijuana (i.e., cannabis) by employees. While one case found in favor of the employer, and the other in favor of the employee, these decisions have emphasized that state law protections for users of medical marijuana are not preempted by federal laws such as the Drug-Free Workplace Act (DFWA). Employers must craft a thoughtful and considered approach to marijuana in the workplace, and in most cases should not take a ...