Singapore has open-sourced the world’s first AI governance testing framework and toolkit, called “AI Verify”. As a single integrated software toolkit operating within a user’s enterprise environment, AI Verify allows users to conduct technical tests on their AI models, and record process checks for reporting to any shareholders or regulatory bodies. Additional toolkits can be built upon AI Verify, for instance, to take into account sectoral requirements applicable to health care entities. The framework and toolkit can be used by any company looking to develop or deploy AI, to validate performa ..read more

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 how users,  browsers and devices interact with websites and mobile apps across the Internet (“Tracking Technology”).   Tracking Technology is the subject of numerous regulatory actions, including ..read more

This is a cross post from Law360.  Please contact Sarah Rathke, Kristin Bryan or John Wyand with any questions. In response to American health care needs during the COVID-19 pandemic, the U.S. is seeing a rapid acceleration in mobile health care, however, this new age form of health care does present some risk and legal implications.  In the recently published Law360 article, we discuss the legal implementations facing mobile health care.  Read the full article here ..read more

On January 8, 2022, Minister of Health Roberto Speranza and Minister for Technological Innovation and Digital Transition Vittorio Colao, in an article published in the Italian press, made a number of announcements about the timing of the Italian government’s intended investment in digital health. This investment forms part of the Italian Recovery and Resilience Plan (RRP). On July 13, 2021, the European Council approved the final version of the RRP. The RRP is part of the EU Next Generation program (NGEU), namely the €750 billion package of which €222 billion has been allocated to Italy. Throu ..read more

In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). The U.S. Patent and Trademark Office has begun charting its path forward for devising and implementing agency rules in response to the U.S. Supreme Court’s decision in United States v. Arthrex. To reso ..read more

Yet another UK Competition and Markets Authority (CMA) merger referral for in-depth investigation, this time in the healthcare sector confirming the CMA’s willingness “to ensure that the NHS does not pay significantly more than it should” for products/services.[1]   The merging parties, Imprivata and Isosec, provide similar Identity and Access Management (IAM) solutions that allow staff of healthcare customers (incl. NHS entities) to access sensitive patient data – in particular, that gives them access to NHS Spine (the IT infrastructure for health and social care in England). The CM ..read more

This is a cross post from Law360.  Please contact Sarah Rathke, Kristin Bryan or John Wyand with any questions. In response to American health care needs during the COVID-19 pandemic, the U.S. is seeing a rapid acceleration in mobile health care, however, this new age form of health care does present some risk and legal implications.  In the recently published Law360 article, we discuss the legal implementations facing mobile health care.  Read the full article here ..read more

Last week, the Department of Health and Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”) announced an Interim Final Rule with Comment Period (“IFC”) delaying compliance dates and timeframes for information blocking and the health IT certification program. This delay will come as a welcome change for “Actors” (i.e., health care providers and developers of certified Health IT) struggling to implement changes amid the COVID pandemic. Background ONC issued the Cures Act Final Rule (the “Final Rule”) in March 2020 to implement the 21st Century Cure ..read more

The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” This draft replaces prior guidance from 2014, and the outlines recommendations for device design, data confidentiality, labeling conventions, and cybersecurity documentation. Key requirements ..read more

A recent report from Lex Machina shows that an increasing number of companies (no doubt including those in the healthcare industry) are turning to the assertion of trade secret claims to protect their intellectual property rights in federal courts – in large part thanks to the passage of the Defend Trade Secret Acts (“DTSA”). Between 2009 and 2016, trade secret suit filings were relatively constant, with an average of approximately 900 cases per year. In 2017 (the first full year the DTSA was in effect), that number increased to 1,134 cases filed, and the filings through the first half of 2018 ..read more