Our FDA team recently published an Insight covering key considerations for artificial intelligence (AI) healthcare application developers and users, highlighting the FDA’s current regulatory scheme for AI/machine learning (ML)-based software, potential FDA enforcement discretion that may apply, and recent FDA developments impacting AI/ML technologies.
Legal Insights and Perspectives for the Healthcare Industry
In the most recent edition of our global telehealth series, we take a look at the United Kingdom’s telehealth expansion, discussing the UK National Health Services’ recently released guidance providing a set of best practice principles for third-party partners to follow. The LawFlash covers telehealth laws and regulations and the role of the EU General Data Protection Regulation, as well as looks forward to future changes and reform.
Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.
Telehealth is a highly regulated field and legal issues can vary across payers, across states, and even across countries. Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In China, the Chinese government has been actively promoting internet-based medicine, even before the COVID-19 pandemic accelerated the need for telehealth services.
We are pleased to announce that Morgan Lewis partners Nancy Yamaguchi and Janice Logan are organizing and participating in the US-Japan Healthcare Connections’ MedTech Emerging Growth Companies 2020 Virtual Roadshow.
We are pleased to announce that we are participating in three upcoming digital health events.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
We are celebrating our 10th year of Technology May-rathon, our annual webinar series focusing on current technology issues, trends, and developments. This year, we have a full schedule of webinars with discussions on privacy and big data, global commerce, fintech, the coronavirus (COVID-19) pandemic, and more. Be sure to register for the many healthcare webinars our lawyers will be presenting on.
As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis.
Healthcare industry lawyers Eric Knickrehm and Jake Harper recently authored a LawFlash analyzing medical licensure waivers issued in connection with the coronavirus (COVID-19) emergency that permit healthcare professionals to receive federal healthcare program reimbursement for telehealth services in states where they do not hold a license.