President Donald Trump held a nearly 2-hour press conference beginning at about 5:35 this evening. It was broken into two segments. The first included Secretary of Defense Mark Esper, Chairman of the Joint Chiefs, Gen. Mark Milley, Attorney General William Barr, National Security Advisor Robert O’Brien, and Chief of Naval Operations Admiral Michael Gilday. In […]
4/1/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Pence held a more than 2-hour press conference beginning at about 5:35 yesterday evening. They were joined by White House Coronavirus Response Coordinator Deborah Birx, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. Summary of the President’s remarks and questions: The President thanked the American
3/31/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump held a 1-hour press conference beginning at about 5:12 this evening. He was joined by HHS Secretary Alex Azar, FDA Commissioner Stephen Hahn, Administrator for the Centers for Medicare and Medicaid Seema Verma, White House Coronavirus Response Coordinator Deborah Birx, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, and
3/30/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 90-minute press conference beginning at about 5:40 this evening. They were joined by Assistant Secretary for Health Admiral Brett Giroir, M.D., White House Coronavirus Response Coordinator Deborah Birx, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, and several executives of private health
3/29/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 1 hour and 40-minute press conference beginning at 5:56 this evening. The President left the conference after about one hour. They were joined by newly-named National Defense Production Act Policy Coordinator Peter Navarro, Secretary of Education Betsy DeVos, Secretary of Agriculture Sonny Perdue, Denton Global
3/27/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 70-minute press conference beginning at 5:27 this evening. The President left the conference after about 40 minutes. They were joined by White House Coronavirus Response Coordinator Deborah Birx, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. Summary of the President’s remarks
3/26/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 75-minute press conference beginning at 5:54 this evening. The President left the conference at approximately one hour. They were joined by Secretary of the Treasury Steven Mnuchin, White House Coronavirus Response Coordinator Deborah Birx, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony
3/25/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 45-minute press conference beginning at 5:42 this evening. They were joined by White House Coronavirus Response Coordinator Deborah Birx, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, and National Economic Council Director Larry Kudlow. Summary of the President’s remarks and questions: The
3/24/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a more than 2-hour press conference beginning at 6:10 this evening. They were joined by Attorney General William Barr, White House Coronavirus Response Coordinator Deborah Birx, and FEMA Supply Chain Task Force Leader Rear Admiral John Polowczyk. Summary of the President’s remarks and questions: The President
3/23/20 OFW Law Daily COVID-19 News Conference Summary Read More »
Today, the President signed an Executive Order to authorize the Sec. of HHS to designate medical equipment as “critical” or “essential” to the national response to the crisis. Under DPA § 102, the President can take action to prohibit the hording of materials designated as “scarce” or “essential.” Sec. 102 prohibits the accumulation of such
Defense Production Act Update – 3/23/2020 Read More »
President Donald Trump and Vice President Mike Pence held a 90-minute press conference beginning at 5:56 this afternoon. They were joined by Federal Emergency Management (FEMA) Agency Administrator Peter Gaynor, White House Coronavirus Task Force Member Peter Navarro, Centers for Disease Control Director Robert R. Redfield, MD, and Surgeon General Vice Admiral Jerome Adams, MD.
3/22/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held an approximately 90-minute press conference beginning at 1:00 this afternoon. They were joined by Assistant Secretary of Health Admiral Brett Giroir, MD, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, Federal Emergency Management (FEMA) Agency Administrator Peter Gaynor, and Secretary of House and
3/21/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a 90-minute press conference beginning at 11:50 this morning. They were joined by Secretary of State Mike Pompeo, Acting Secretary of Homeland Security Chad Wolf, Secretary of Health and Human Services Alex Azar, White House Coronavirus Response Coordinator Deborah Birx, and National Institute of Allergy and
3/20/20 OFW Law Daily COVID-19 News Conference Summary Read More »
President Donald Trump and Vice President Mike Pence held a press conference beginning at 12:45 this afternoon. They were joined by White House Coronavirus Response Coordinator Deborah Birx, Centers for Medicare & Medicaid Services Administrator Seema Verma, Secretary of Veterans Affairs Robert Wilkie, and Secretary of Defense Mark Esper. Summary of the President’s remarks: 1.
3/18/20 OFW Law Daily COVID-19 News Conference Summary Read More »
I. Overview of Final Rule. On November 2nd, the Centers for Medicare & Medicaid Services (CMS) issued the final rule for the second year of the Quality Payment Program (QPP). The rule outlines the requirements for the 2018 Merit-Based Incentive Payment System (MIPS) as well as Advanced Alternative Payment Models (APMs). Like the proposed
2018 Quality Payment Program Final Rule Overview Read More »
In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback regulatory safe harbor. The new safe harbor would reduce regulatory uncertainty and expressly permit business entities in the healthcare
Kristen O’Brien serves as Counsel in OFW Law’s Health Industry Policy and Regulatory Practice, which represents clients in the health care delivery system and innovative life sciences areas. She is principally responsible for the group’s work with health care delivery system clients, including large physician groups, integrated health systems and other provider organizations. She also
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 health emergency in both states and will waive certain sanctions and penalties under
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 system and innovative life sciences areas. To provide leadership for this practice, OFW Law is also
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 has been a bipartisan issue. Right? Not so fast . . . Trump
Trump’s New OCR Director and HIPAA Policy Read More »
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!), individuals in a position of responsibility can be prosecuted criminally for what are often
2016 – Gone But Not Forgotten Read More »
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 year, as provided for by the Congressional Review Act of 1996, or is
Food Rules Potential Targets for Elimination or Revision Read More »
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 medical privacy, an issue during the 2016 campaign season. Accordingly, privacy and related issues were not a major part
What Will A Trump Administration Mean For The Medical Privacy Landscape? Read More »
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 Assessment (OEHHA) relative to the prioritization of aspartame for possible preparation of hazard identification materials and prospective inclusion on
Aspartame Potentially Subject to California Prop 65 Listing – Update 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 America. Only a single attorney in each practice area and designated metropolitan
OFW Founder Rick Frank Named Best Lawyers® Washington DC Health Care Lawyer of the Year Read More »
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 patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with
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. FDA published earlier versions of the guidance document in May 1997 and May 2007. This guidance is a second edition of
FDA Finalizes Guidance Document about Medical Foods Read More »
Please see Dr. Nina Fedoroff and former USDA Secretary John Block’s op-ed featured in the New York Times on April 6, 2016 – Mosquito vs. Mosquito in the Battle Over the Zika Virus.
NYT: Mosquito vs. Mosquito in the Battle Over the Zika Virus Read More »
As a foundation for moving forward with Phase II of its Audit Program of Covered Entities (CEs) and their Business Associates (BAs), HHS’s Office for Civil Rights (OCR) has quietly released its beefed-up Audit Protocol (Protocol). Significantly, this revised, more robust, Protocol more closely ties the audit “checklist” to the respective provisions of the implementing
Medical Privacy Update: OCR Issues Revised Audit Protocol For Phase II Read More »
By Marshall Matz, as published in Agri-Pulse Q. Is there a connection between the Zika virus and global food security?A. Yes. Genetic engineering has an important role to play in meeting both challenges. The mosquito is the deadliest animal on earth. According to the World Health Organization, mosquitoes are the greatest menace spreading malaria, dengue, yellow fever
The Zika-Agriculture Connection Read More »
Late last week, HHS’s Office for Civil Rights (OCR) and Office of the National Coordinator for Health IT (ONC) issued two Fact Sheets (or guidance documents) intended to assist regulated industry in Understanding Some of HIPAA’s Permitted Uses and Disclosures of protected health information (PHI): Permitted Uses and Disclosures: Exchange for Health Care Operations, 45
In our last blog on medical privacy, we noted that HHS’s Office for Civil Rights (OCR) promised that a number of HIPAA guidances were forthcoming in the next several months. It appears that (at least so far) OCR is keeping its promise, issuing its long-awaited guidance addressing Individuals’ Right under HIPAA to Access their Health
The Secretaries of Agriculture and Health and Human Services have released the 2015-2020 Dietary Guidelines for Americans (DGA) following what had been a captivating review of the Scientific Report of the Dietary Guidelines Advisory Committee, a process that began in 2013. In the end, the Guidelines continue many of the recommendations made by the 2010
MEDICAL PRIVACY UPDATE: New PHI Disclosures Permitted for Firearm Background Checks Earlier today, HHS published a Final Rule modifying the HIPAA Privacy Rule (45 C.F.R. § 164.512) to allow certain Covered Entities to disclose limited PHI to the FBI’s National Instant Criminal Background Check System (NICS) to help identify individuals subject to the “Federal mental
Medical Privacy Update and 2015 Retrospective Read More »
Happy New Year, readers! Yet another year has come and gone. I hope that 2015 was a good year for you, professionally and personally. As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and Commerce Committee released a long awaited discussion draft of the
2015 In Retrospect Read More »
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