On May 23, 2019, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced that Medical Informatics Engineering, Inc. (MIE) agreed to pay $100,000 to settle alleged HIPAA violations that...more
As the health care delivery system continues to evolve, on May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a draft guidance document to state survey agency directors entitled, “Guidance for Hospital...more
On May 6, 2019, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Touchstone Medical Imaging (TMI) agreed to pay $3,000,000 to settle alleged HIPAA violations arising out of...more
On April 26, 2019, the U.S. Department of Health and Human Services (“HHS”) published an Enforcement Discretion letter announcing it is meaningfully lowering the cumulative annual civil money penalties (“CMPs”) it will apply...more
Health care providers are heavily reliant on technology in providing clinical services. The findings from a recent research study highlight the significant threat of cyber risks in health care that is in addition to the...more
INTRODUCTION -
The Saul Ewing Arnstein & Lehr, LLP health care practice group includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery...more
2/1/2019
/ Cannabidiol (CBD) oil ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Malpractice ,
Medical Marijuana ,
National Practitioner Data Bank (NPDB) ,
OCR ,
Popular
Agency continues to promote use of "robust performance criteria" and "modern predicate devices" -
On January 22, 2019, the U.S. Food and Drug Administration (FDA or the Agency) detailed in a Final Guidance document the...more
On December 28, 2018, the U.S. Department of Health and Human Services ("HHS") released a publication, Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (the "Cybersecurity Guidance"). ...more
There were two important HIPAA developments during this past week. First, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that Pagosa Spring Medical Center (“PSMC”), a Colorado...more
On December 4, 2018, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced that Advanced Care Hospitalists (ACH) agreed to pay $500,000 to settle alleged HIPAA violations arising out of ACH...more
On November 26, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Allergy Associates of Hartford, P.C. (AAH) agreed to pay $125,000 to settle alleged HIPAA violations...more
On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive...more
On October 15, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Anthem, Inc. (Anthem) agreed to pay $16 million to settle allegations relating to HIPAA violations...more
Physicians, athletic trainers and other sports medicine professionals who travel to another state with an athletic team to provide medical care for that team will now have the benefit of being able to provide medical services...more
When the calendar turns to July, the new month may create excitement and anxiety for individuals: July 4th celebrations; hot weather; vacation plans; and yes, the calendar year is halfway done. For physicians, July may also...more
The U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR") announced earlier this month that an HHS administrative law judge ("ALJ") ruled in favor of the OCR on summary judgment and required MD...more
On June 1, 2018, New Jersey Governor Phil Murphy signed into law the “Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act” (the “Act”). In the preamble to the Act, the New Jersey...more
There continues to be significant media attention on health care privacy and data breaches, the opioid crisis, Medicaid funding and expansion efforts, telemedicine, and mergers and acquisitions affecting the health care...more
Verizon recently released its 11th annual Data Breach Investigation Report (DBIR). The DBIR is a helpful tool for everyone in the health care sector to understand trends in cybercrime and most typical causes of security...more
On February 13, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that a receiver appointed to liquidate the assets of Filefax, Inc. agreed to pay $100,000 to settle...more
2017 was a year in contrasts for the health care delivery system. Congress and President Trump made several attempts to “repeal and replace” the Affordable Care Act. Controversy about marijuana continued as more states...more
2/14/2018
/ Affordable Care Act ,
Cybersecurity ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Individual Mandate ,
Marijuana ,
Medical Marijuana ,
Medicare Advantage ,
OCR ,
PHI ,
Popular ,
Telehealth ,
Trump Administration
On February 1, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Fresenius Medical Care North America (FMCNA) agreed to pay $3.5 million and enter into a Corrective...more
In the last days of the administration of Governor Chris Christie, he signed a new law relating to “surgical practices” that will impact New Jersey providers.
A1935/S287 requires all “surgical practices” to be licensed by...more
On December 28, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that 21st Century Oncology, Inc. (21CO) agreed to pay $2.3 Million in lieu of potential civil money...more
In early June 2017, the U.S. Department of Health and Human Services (HHS) Health Care Industry Cybersecurity (HCIC) Task Force released a “Report on Improving Cybersecurity in the Health Care Industry” (the Report). The...more