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 … 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 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 … Continue Reading
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). … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
Let’s hope you don’t pay that much to encrypt electronic Protected Health Information (ePHI). How about a total of $4.3 million over two years? Well, that’s the total penalty for encryption violations assessed by Health and Human Services (HHS). An Administrative Law Judge found the penalty could have been much worse. The facts are sobering. … Continue Reading
PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC Majority Of Federal Communications Commission (FCC) Supports 40%+ Annual Increase In Rural Health Care Program Funding – Following on a proposal to review annual funding for the FCC’s Rural Health Care Program (RHCP), which currently provides $400 million in annual subsidies for telecommunications … Continue Reading
In a May 22, 2018 article that appeared in Law360 Expert Analysis piece, Squire Patton Boggs partner Elliot Golding writes, “There is no shortage of attention on health care data privacy and cybersecurity, with an avalanche of new and proposed government and regulatory initiatives underway. Although health care has long been a key target for … Continue Reading
CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29 The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as … Continue Reading
In a podcast interview with Healthcare InfoSecurity, Squire Patton Boggs Partner Elliot Golding addresses evolving healthcare privacy and security issues, particularly complex issues involving Internet of Things (IoT) devices. This includes addressing new risks when connected devices link to legacy systems, the applicable regulatory environment, and other key issues companies operating in the health care … Continue Reading
A recent blog post summarized Health Insurance Portability and Accountability Act (“HIPAA”) enforcement settlements for Virtual Medical Group (“VMG”) in New Jersey and EmblemHealth in New York that may signal a broader trend of increased state HIPAA enforcement. Under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act’s amendment to HIPAA, codified at … Continue Reading
The U.S. Food and Drug Administration (“FDA”) recently approved the Viz.Ai Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. In an article published March 8, 2018 as a PG Alert Email from the American Health Lawyers … Continue Reading
The FCC’s Notice of Proposed Rulemaking (NPRM) to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP), has now been published in the Federal Register. Interested parties may submit initial comments on the FCC’s proposals by February … Continue Reading
Noting that technology and telemedicine are assuming an increasingly critical role in healthcare delivery, the FCC has initiated a proceeding to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP). These changes would potentially affect existing as … 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
Last week, the Federal Communications Commission (the Commission) released an Order denying a Petition for Declaratory Ruling by Kohll’s Pharmacy & Homecare, Inc. (Kohll’s) originally filed on March 29, 2016, requesting the Commission to declare that certain faxes describing the health benefits of flu vaccinations did not constitute unsolicited advertising under the Telephone Consumer Protection Act (TCPA) … Continue Reading
Last month, the U.S. Department of Health and Human Services (HHS) entered into a historic Memorandum of Understanding (MOU) with Cuba’s Ministry of Public Health. The MOU establishes coordination across a broad spectrum of public health issues, including: Healthcare systems and public health management; Quality management and patient safety systems in hospitals and outpatient settings; … Continue Reading
Hospital systems are on notice for ransomware attacking their health IT systems after three hospital systems are reported to be victims of computer viruses. In response, one hospital system paid almost $17,000 in Bitcoin to retrieve their EHR, while the other two hospital systems worked off paper records and backup systems for a few days … Continue Reading
Telemedicine, Follow-Up Care and State Licensure: The Problem Illustrated As the delivery of healthcare services adapts to the digital age, providers, payers and patients are gradually exploring telemedicine’s possibilities. Evidence that delivering certain routine services via telemedicine may increase patient access to care and decrease cost without sacrificing quality has only served to accelerate this … Continue Reading
Health care fraud accounts for billions of the US health expenditure each year. This week HHS published a study addressing possible deficiencies in CMS’ capability to address fraud vulnerabilities and ensure the integrity of electronic health records (“EHR”) systems which CMS and its contractors use to pay Medicare claims. Concerns about whether CMS’ oversight and … Continue Reading
