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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…
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…
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
On December 21, 2018, the Department of Justice (“DOJ”) announced in a press release the recoveries obtained in settlements and judgments from civil matters involving fraud and those brought under the False Claims Act (“FCA”) for the fiscal year (“FY”) ending September 30, 2018. While total recoveries were $2.88 billion—the ninth consecutive year exceeding $2 billion—this was down almost $600 million from FY 2017, the lowest level since 2009 and the second year in a…
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,…
On December 14, 2018 the Department of Health and Human Services, Office for Civil Rights (“OCR”) formally issued a Request For Information (“RFI”) seeking public input on “ways to modify the HIPAA Rules to remove regulatory obstacles and decrease regulatory burdens in order to facilitate efficient care coordination and/or case management and to promote the transformation to value-based healthcare, while preserving the privacy and security of PHI.”  OCR is seeking comments for a series of…
On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on…
On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and…
During a November 29, 2018 speech, Deputy Attorney General Rod Rosenstein announced changes to Department of Justice (“DOJ”) policy concerning individual accountability in corporate cases.  The announcement followed the DOJ’s year-long review of its individual accountability policies and the September 2015 memorandum issued by then-Deputy Attorney General Sally Yates, commonly known as the “Yates Memo.” While making clear that pursuing individuals responsible for corporate wrongdoing remains a top priority in every investigation conducted by DOJ,…