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Legal Insights and Perspectives for the Healthcare Industry

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.

The Centers for Medicare and Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning telehealth, remote physiologic monitoring (RPM), and new remote therapeutic monitoring codes. Coming on the heels of the significant telehealth waivers put in place during the COVID-19 public health emergency (PHE), CMS proposes to continue the steady expansion of virtual care options with this rule.
It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).
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.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
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.
DOJ recently announced a massive coordinated effort with other federal agencies to charge 345 defendants allegedly responsible for over $6 billion in fraud. DOJ, OIG, FBI, DEA, and various US Attorneys’ Offices in 51 federal districts teamed up to unveil charges against more than 100 doctors, nurses, and licensed clinical personnel.
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.