This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
7/28/2025
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DMEPOS ,
EMTALA ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medical Devices ,
OIG
Digital health is one of the fast-growing segments of the healthcare market, with patients, clinicians and regulators increasingly aligned behind the opportunities that digitization presents.
Over the last three years,...more
3/21/2023
/ Controlled Substances Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Dobbs v. Jackson Women’s Health Organization ,
Healthcare Fraud ,
Medicare ,
New Legislation ,
New Regulations ,
OIG ,
Proposed Legislation ,
Proposed Regulation ,
Public Health Emergency ,
Roe v Wade ,
State and Local Government ,
State Legislatures ,
Telehealth ,
Telemedicine
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
2/6/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Health Record Incentives ,
Enforcement Actions ,
Health Care Providers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
OIG ,
Popular ,
Regulatory Reform ,
Request For Information ,
Telehealth ,
Telemedicine
The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US...more