2020: An Unprecedented Year for Digital Health
The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more
The Office of the National Coordinator for Health Information Technology (ONC) announced a new proposed rule on April 11, 2023, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more
During the past several months, companies in the digital health space have risen to address the COVID-19 pandemic and surging demand for virtual care. Investors have also responded, pouring record amounts of funding into the...more
On October 30, 2020, the Office of the National Coordinator for Health Information Technology (ONC) issued an interim final rule (IFR) with comment period delaying the compliance dates for certain regulatory requirements set...more
On April 21, 2020, the U.S. Department of Health and Human Services released a series of announcements signaling its intention to finalize and enforce certain aspects of the Office of the National Coordinator (ONC) Cures Act...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
On March 9, 2020, the U.S. Department of Health and Human Services (HHS) finalized two sets of regulations that are intended to increase patients' access to health data. As explained by HHS Secretary Alex M. Azar, "These...more
Healthcare companies have raised over $37.5 billion globally in the first three quarters of 2019 in over 3,409 private venture funding rounds according to a recent CB Insights report. Compared to full year 2018, the report’s...more
The digital health market is expected to grow beyond $379 billion by 2024, with a 27.7 percent compounded annual growth rate over the coming years. This activity is fueled by increasing demand for remote monitoring services,...more
The US M&A market delivered another year of strong performance in 2018. Though deal volume dipped 2 percent year-on-year to 5,682 deals, deal value was up by 15 percent over the period, to US$1.5 trillion - A number of...more
At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more
Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for...more
2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more
The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via...more
The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more
On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products...more
The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more
Basil Leaf Technologies recently presented their DxtER device at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego. ...more
Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more
...We invite you to read our inaugural Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than 3,000 years,...more
Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more