On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the … Continue Reading
Key Takeaway: Organizations must conduct a fact-based analysis to determine whether health data collection and tracking technology deployed on their websites and mobile apps complies with the federal Health Insurance Portability and Accountability Act (“HIPAA”) and other applicable laws and guidance. Cookies, web beacons, and similar technology are used to collect and analyze data about … Continue Reading
On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (“Draft Guidance”). The Draft Guidance, available here, provides clarity on the scope of FDA’s … Continue Reading
The recent WannaCry ransomware attack and the bevy of breaches over the past few years demonstrate that cyber risks in the healthcare arena are substantial and widespread. The Department of Health and Human Services (HHS) Health Care Industry Cybersecurity (HCIC) Task Force Report (HCIC Report), required under the federal Cybersecurity Information Sharing Act of 2015, … Continue Reading
Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality. Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right. The 21st Century Cures Act, passed into law … Continue Reading
Providers and policy makers have struggled to find solutions to rein in health care costs while improving clinical outcomes. Clinical integration is one approach to meet these challenges. In short, clinical integration is a legal arrangement for healthcare provider integration that involves a carefully structured collaboration of healthcare professionals to provide coordinated care across multiple … Continue Reading
On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading
On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations. The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”) include significant easing of Conditions of … Continue Reading
In the December 2013 edition of AHLA Connections, Tom Zeno and Emily Root analyzed the application of the attorney-client privilege to in house counsel and provided five practice tips to maximize the protection of the privilege for in house counsel. In the article, Emily and Tom explore often overlooked principles of the privilege and illustrate … Continue Reading
Scott A. Edelstein co-authored Medical Transcription: Business Transparency and Professional Accountability, which was published in the June issue of Compliance Today. Scott discusses how the medical transcription industry is developing greater transparency and professional service accountability in preparation for the transition to digital health records management. The industry’s professional society and trade association collaborated to … Continue Reading
Staying on top of rapid change in the medical industry is a major challenge for our clients, and the American Health Lawyers Association does an incredible job of tracking trends so we can keep our clients up to speed. I’m honored to have been asked to present at its conference, “Institute on Medicare and Medicaid … Continue Reading
