In response to the tragic fallout from Hurricane Harvey, an unprecedented storm that decimated the city of Houston and a large swath of the Gulf Coast of Texas and Louisiana, the U.S. Department of Health and Human Services (HHS) declared a public he…
Read More
Tags: Business Associate, Covered Entity, Emergency Preparedness, HHS, HIPAA, Hospital, Hurricane Harvey, Jonathan M. Weinrieb, Louisiana, Medical Privacy, OCR, Office for Civil Rights, Patient Authorization, Protected Health Information, Texas
OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice. The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery syst…
Read More
Tags: Attorney, Brett T. Schwemer, FDA, Health Care, Health Industry Policy and Regulatory Practice, HHS, Ladd Wiley, Law Firm, Life Sciences, Lobbyist, Medicare, OFW Law, Richard L. Frank
As federal policy rapidly develops under the Trump Administration, much of it reversing or seeking to reverse the Obama legacy, the world of medical privacy (at least that which is on the books for now) remains static – after all, privacy always ha…
Read More
Tags: 21st Century Cures Act, Health and Human Services, Health Information, HHS, HIPAA, HITECH, J. Mason Weeda, Jonathan M. Weinrieb, Medical Privacy, OCR, Office for Civil Rights, President Trump, Roger Severino, Trump Administration
Happy 2017, everyone! 2016 has come and gone. Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention.
As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),…
Read More
Tags: 2016, 21st Century Cures Act, Agriculture, Animal Drug, Arthur Y. Tsien, Bioengineered Food Disclosure Standard, Congress, Drug, Election Day, Feed, Feinstein Institute, Food, Food Drug and Cosmetic Act, FSIS, Genetically Engineered, Guidance, HIPAA, Law Firm, Lawyer, Mecadox, Medical Privacy, Misbranded Drug, Nutrition Facts, OFW Law, Park Doctrine, Rulemaking, Salmon, Sodium
Ever since the election we have been asked which Obama Administration regulations and executive actions are likely to be stricken by the new Trump Administration or the 115th Congress. Will the focus be on the rules issued since mid May of this yea…
Read More
Tags: Agriculture, Appropriations, Congress, Continuing Resolution, Donald Trump, Farm Bill, FDA, Food, Freedom Caucus, Labeling, Regulation, Roger R. Szemraj, SNAP, Trump Administration, USDA
With President-Elect Donald Trump’s unlikely victory in Tuesday’s election, we begin to look ahead at what the Trump Administration will mean from a medical privacy perspective. Neither the media, nor Trump himself, made privacy, much less medi…
Read More
Tags: Ben Carson, Cybersecurity, Donald Trump, HHS, HIPAA, HITECH, J. Mason Weeda, Jonathan M. Weinrieb, Law Firm, Lawyer, Medical Privacy, Newt Gingrich, Obamacare, OCR, President, Privacy, Regulation, Rich Bagger, Rick Scott, Treatment Communication, Trump Administration
As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assess…
Read More
Five OFW Law Attorneys Named to 2017 Best Lawyers in America for FDA Law
One of OFW Law’s Founding Principals, Richard L. Frank, was recognized as the Health Care Lawyer of the Year in the 2017 Washington, D.C., edition of The Best Lawyers in Amer…
Read More
Tags: Arthur Y. Tsien, Attorney, Best Lawyers, FDA Law, Food and Beverage Law, Frederick H. Branding, Health Care Law, Law Firm, Lawyer, OFW Law, Philip C. Olsson, Richard L. Frank, Stephen D. Terman
Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share…
Read More
Tags: Business Associate, CDRH, Covered Entities, Guidance, Health Information, HIPAA, J. Mason Weeda, Jonathan M. Weinrieb, Medical Device, OCR, PHI, Privacy, Public Health Information
FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016). The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115.
F…
Read More
