This blog post focuses on health care companies who are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply antitrust law to the modern, data-driven economy. Amid these myriad changes in technology and the law, the time is ripe to consider what the growth of AI in health care means for antitrust compliance.
This article focuses on the changes to the Medicare Advantage (MA) and Part D programs marketing rules at 42 C.F.R. parts 422 and 423, which are applicable for all contract year 2024 marketing and communications beginning September 30, 2023.
This article highlights key considerations for hospitals in evaluating, developing, and implementing an ASC transaction, with a focus on fraud and abuse considerations related to investing alongside physicians. It also highlights the type of regulatory analysis that providers and others contemplating transactions involving health care entities must consider and address.
The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require special consideration during development of a patent portfolio, stakeholders across engineering, legal, and executive teams in both established companies and start-ups can leverage it to create valuable intellectual property (IP) assets in the marketplace.
Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will sunset at varying times.
Between now and 2030, the biopharma sector is expected to be rocked by a number of high-profile patent cliffs that are likely to reshape the market in potentially unpredictable ways. A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch.
Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.
The presence of private equity (PE) investment has exploded in recent years in all areas of the health care sector. PE in health care is a good thing when done right: It can pave the way for much needed innovation, efficiency, and nontraditional care delivery models. However, government regulators, media journalists, some health care practitioners, and private parties are watching PE investment with growing suspicion that profit-driven goals may conflict with the quality of care for patients.
The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the Report, 2022 milestones include progress in diagnostics, therapeutics and new treatment modalities that are covered in this resource from Foley and Lardner LLP.
With the pandemic, there came a digital health explosion, with companies working swiftly to bring new technologies to light that would pave the way forward in telehealth and other critical areas. We saw an incredible interest in this space then, but what is the state of digital health now? This resource from Foley & Lardner LLP looks at data from public and private financing markets in the digital health space in 2022, and look forward to what to expect in 2023.