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
The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the...more
This blog is the first in our Digital Health Trends series.
Digital health’s explosion in the last few years has led to the proliferation of new technologies and novel solutions to long-standing health problems. FemTech,...more
On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more
8/23/2022
/ Affordable Care Act ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Executive Orders ,
Gender Identity ,
Proposed Rules ,
Rulemaking Process ,
Section 1557 ,
Sexual Orientation Discrimination ,
Women's Rights
Last month, in Cummings v. Premier Rehab Keller, P.L.L.C., the Supreme Court denied a petitioner’s right to emotional distress damages in a private action brought under federal anti-discrimination laws. The Petitioner, a...more
5/26/2022
/ Affordable Care Act ,
Civil Rights Act ,
Compensatory Damages ,
Cummings v Premier Rehab Keller PLLC ,
Disability Discrimination ,
Emotional Distress Damages ,
OCR ,
Rehabilitation Act ,
SCOTUS ,
Section 1557 ,
Section 504
The State Attorneys General in New York and New Jersey recently settled with four companies over alleged HIPAA noncompliance following phishing attacks. The New Jersey settlements were brought against three NJ-based cancer...more
2/28/2022
/ Data Breach ,
Data Security ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
New Jersey ,
New York ,
Patients ,
Personally Identifiable Information ,
Phishing Scams ,
Settlement ,
State and Local Government ,
State Attorneys General
The use of digital health to deliver healthcare has seen unprecedented growth over the past few years, with significant acceleration due to the COVID-19 Public Health Emergency (PHE). As patients seek ways to empower...more
Just as we thought 2022 was going to be significantly different than 2021, December 2021 and January 2022 events have thrown us for another (pandemic) loop. We anticipate that some of the privacy and cybersecurity...more
1/12/2022
/ Artificial Intelligence ,
Auto-Dialed Calls ,
Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
California Privacy Rights Act (CPRA) ,
CAN-SPAM Act ,
CARU ,
CDPA ,
Consumer Privacy Rights ,
COPPA ,
Cross-Border Transactions ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Employee Tracking ,
EU ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Identity Theft ,
Machine Learning ,
Mobile Privacy ,
Ransomware ,
SCOTUS ,
TCPA
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
11/23/2021
/ Artificial Intelligence ,
Digital Health ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Patients ,
Popular ,
Privacy Laws ,
Transparency