Originally published in Healthcare Michigan, Volume 41, No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more
As the year 2020 began, it would have been difficult for most Americans to imagine how life, as we knew it at that time, would change in the coming months and years. You likely recall generally, if not specifically, that on...more
The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....more
7/27/2022
/ Canada ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
CGMP ,
Cross-Border Transactions ,
Distributors ,
Drug Testing ,
Due Diligence ,
Food and Drug Administration (FDA) ,
Health Claims ,
Interstate Commerce ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Suppliers ,
Webinars
The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food,...more
From new fraud and abuse rules, to telehealth and tax legislation to health care privacy and private equity in the healthcare space, a lot has changed in health law over the past year. Please join us for a two-day virtual...more
10/28/2021
/ Anti-Kickback Statute ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Data Privacy ,
Data Security ,
Federal Taxes ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
Mental Health ,
New Rules ,
Non-Compete Agreements ,
Pending Legislation ,
Physicians ,
Popular ,
Private Equity ,
Proposed Legislation ,
Stark Law ,
Surprise Medical Bills ,
Tax Legislation ,
Telehealth ,
Value-Based Care ,
Webinars
“Unprecedented” may be the most commonly-used adjective in the English language at the moment, but it accurately describes the circumstances faced by our nation and others as COVID-19 continues to spread throughout our...more
In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more
Where is your PHI Data Traveling Today?
With most vendors offering and pushing cloud computing solutions and offsite data backup, or guaranteeing offsite backup of data they process for you, many HIPAA covered entities and...more
8/28/2017
/ Church Plans ,
Clinical Trials ,
Data Protection ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
International Data Transfers ,
Pensions ,
Personally Identifiable Information ,
PHI ,
Retirement Plan
Preventing unintended or unauthorized disclosure of protected health information is an ever-present goal of all covered entities and business associates. However, protective firewalls and electronic data security measures are...more
Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more
RESPONDING TO SUBPOENAS AND OTHER REQUESTS FOR PERSONAL HEALTH INFORMATION: TAKE THEM AT FACE VALUE -
Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from...more
8/24/2015
/ Administrative Proceedings ,
Anti-Kickback Statute ,
De-Identified Protected Health Information ,
False Claims Act (FCA) ,
First-to-File ,
Fraud Alerts ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
KBR (formerly Kellogg Brown & Root) ,
OIG ,
PHI ,
Physician Compensation Arrangements ,
Protective Orders ,
Qui Tam ,
SCOTUS ,
Stark Law ,
Statute of Limitations ,
Subpoenas ,
Wartime Suspension of Limitations Act ,
Whistleblowers
Although the HIPAA Omnibus Rule (the “Rule”) went into effect nearly 18 months ago, the transition period for bringing business associate agreements into compliance with the Rule’s new requirements will end on September 23,...more
Recent Trends in HIPAA Liability -
Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including...more