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In July 2024, Pennsylvania enacted two significant pieces of legislation relating to telemedicine and physician noncompetition agreements that will have a meaningful impact within the healthcare delivery system with the...more
On June 10, 2024, the U.S. Justice Department announced that together with the Federal Trade Commission, it filed an amended complaint against telehealth company Cerebral Inc., Cerebral’s founder and former Chief Executive...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
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...more
Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more
The regulatory scrutiny on telemedicine and digital health companies continues to tighten, whether it is privacy warning shots, new direct-to-consumer (DTC) advertising limits, a wave of reimbursement audits, or multistate...more
As the COVID-19 pandemic in the United States is easing, telemedicine is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers...more
Telemedicine and remote patient monitoring companies often want to maintain open communication channels with patients, whether it be scheduling, medication reminders, engagement pings, or even new product and service updates....more
The use of digital technologies has accelerated almost overnight due to the COVID-19 pandemic, with healthcare providers and patients finding new and innovative, socially-distanced ways to deliver and receive services. This...more
Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
On May 29th, the Federal Trade Commission (FTC) submitted a comment to the Centers for Medicare & Medicaid Services (CMS) in support of reducing reimbursement requirements for telehealth services. CMS accepted public comments...more
We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition. Originally published in Dermatology Times...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more
In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more
On June 21, 2017, the Federal Trade Commission (Commission) voted to close its investigation into whether the Texas Medical Board (TMB) violated federal antitrust laws by adopting rules that restricted the practice of...more
The U.S. Department of Justice and Federal Trade Commission have sided with Teledoc, Inc., one of the country’s biggest telemedicine companies, in its legal battle with the Texas Medical Board. The two agencies filed a joint...more
On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via...more
In a public comment supporting Alaska’s proposed telemedicine legislation, the Federal Trade Commission (FTC or Commission) reiterated its broad support for telemedicine services, quoting its own 2004 analysis: “When used...more
Key Findings - ..ACA enrollment reached 11.3 million by the end of the third open enrollment period, surpassing HHS expectations. Three-quarters of the enrollees were from the 38 states that use the healthcare.gov...more
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and...more
The Supreme Court has ruled that when an oversight mechanism created by a State —here a State Board — is under the control of those it was supposed to be regulating (sometimes referred to by economists as “regulatory...more