Gradually, data is being recognized as an asset in an increasingly data-hungry healthcare industry. In the tenth episode of Sheppard Mullin’s Health-e Law Podcast, Arti Bedi Pullins, President and Chief Healthcare Officer at...more
Last week, in a significant win for the American Hospital Association plaintiff, the U.S. District Court for the Northern District of Texas issued an opinion vacating the Department of Health and Human Services’ (“HHS”)...more
The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a...more
Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin’s Health-e Law Podcast, Deirdre O’Neill, Chief Commercial & Legal Officer at...more
In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig...more
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more
The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized....more
1/17/2024
/ Digital Health ,
Elder Care ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Hospice ,
Life Sciences ,
Mental Health ,
Patients ,
Technology Sector ,
Telehealth
Expansion of AI in Healthcare -
At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more
In the inaugural episode of Sheppard Mullin’s Health-e Law podcast, renowned expert Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, discussed emerging issues for health-tech’s data collection and use...more
Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses...more
11/13/2023
/ Artificial Intelligence ,
Biden Administration ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Healthcare ,
OMB ,
Privacy Laws ,
Private Sector ,
Public Sector ,
Regulatory Agenda
On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department...more
11/8/2023
/ American Hospital Association ,
Class Action ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Third-Party ,
Tracking Systems ,
Web Tracking
At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our...more
10/19/2023
/ Acquisitions ,
Artificial Intelligence ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Investment ,
Investors ,
Life Sciences ,
Medicare ,
Mergers ,
Technology
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more
10/18/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Mental Health ,
Patient Access ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as...more
At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be...more
Texas is joining a growing number of states in passing comprehensive privacy legislation intended to safeguard consumer personal data. Specifically, the Texas Data Privacy and Security Act (the “Act”) adds protections for...more
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
5/15/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations ,
Waivers
Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more
On April 12, 2023, OCR issued a Notice of Proposed Rulemaking (“NPRM”) to strengthen HIPAA’s protections around reproductive health care privacy. The NPRM responds to President Biden’s Executive Order 14076, which directed...more
In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable...more
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008...more
3/8/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third...more
Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through...more
Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance...more
The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more
12/13/2022
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth