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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Are Healthcare Systems Being Held Hostage by Ransomware?

by Revision Legal on

Healthcare ransomware is one of the biggest cybersecurity concerns in existence and it may have particularly serious implications for healthcare systems. Ransomware is a form of malicious software code that is somehow...more

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

by Arnall Golden Gregory LLP on

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

Dr. Reddy’s to Install GE Healthcare’s FlexFactory

by Goodwin on

GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to...more

The State AG Report Weekly Update

by Cozen O'Connor on

2018 AG Elections Update- Phil Weiser Announces Bid for Colorado Attorney General- Phil Weiser has formally registered his candidacy to become Colorado AG. Weiser, a Democrat, is the first candidate to formally...more

Romaine Calm: FSVP is Approaching

Does FSVP Apply to You? Are you the importer, consignee, or agent for food imported into the United States? If so, the Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP), a key...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

WannaCry Global Ransomware Attack

A global ransomware attack began early last Friday and has affected businesses and government entities in 150 countries, including Britain’s national health system, FedEx, Spain’s Telefónica, and the Russian Interior...more

Liability Challenges to the Medical Devices Industry

by Hogan Lovells on

On 5 April 2017, despite uncertainties about the regulatory legal scope, the practical applicability of certain provisions, and the law's realizability within the given transition period, the European Parliament adopted the...more

How Will the Appointment of a Special Counsel Affect the Administration's Regulatory Agenda?

by Mark Mansour on

The news of the the appointment of Robert Mueller as special counsel to be investigate the Russia-Trump connection rocked Washington. The immediate concern was how the White House would surmount the distraction and where all...more

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

by Arnall Golden Gregory LLP on

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

Take-Aways from WannaCry

We have read multiple reports on WannaCry and if you are reading this and don’t know what WannaCry is, Google it for the background story. The clear message is this is not the last major attack we will see, and future attacks...more

Supreme Court Emphatically Defends Arbitration Agreements from State Interference

by Littler on

On May 15, 2017, the U.S. Supreme Court reiterated the principle that the Federal Arbitration Act (FAA) requires states to treat arbitration agreements just as they treat other types of contracts. In Kindred Nursing Centers...more

Dispute Between Brothers Demonstrates Need to Plan for Long-Term Care

A recent New Jersey appeals court case demonstrates how important it is for families to come up with a long-term care plan before an emergency strikes. The case involves two brothers who got into a fight over whether to place...more

Edinburgh Royal Hospital for Sick Children community right to buy application declined

by DLA Piper on

The Royal Hospital for Sick Children, Edinburgh is located in Marchmont and Sciennes, a leafy, desirable, residential area located a mile or so to the south of the city centre. The site extends to just over 4 acres and...more

Scott Gottlieb’s Stance on Biosimilars

by Goodwin on

On May 11, 2017, Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food & Drug Administration. Before his confirmation, Gottlieb was vocal about his disapproval of the FDA’s “well-established” attitude: an...more

Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit...more

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017....more

Some Cardiac Monitoring Patents Beat Alice Challenge, While Others Fail to Survive

In the time since Alice changed the landscape of patent eligibility for certain types of inventions, the Federal Circuit has begun pumping out opinions interpreting this landmark Supreme Court case. The expanding body of law...more

CMS Releases the Proposed Part D DIR Reporting Requirements for 2016

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline....more

Privacy Tip #88 – The Challenge of Keeping Up with Patches

Over the past week, many clients and individuals have asked me why some companies and health care facilities were devastated by the WannaCry ransomware, and why others made it through the weekend without a blink of an eye....more

House Republicans Make a Second Attempt at Passing the AHCA Repeal Legislation

by King & Spalding on

Congressman Tom MacArthur (R-NJ), a co-chair of the moderate House Republican Tuesday Group, in consultation with Congressman Mark Meadows (R-NC), chairman of the conservative House Freedom Caucus, proposed an amendment to...more

No Pre-Emption Exemption - The U.S. Supreme Court and the Kentucky Supreme Court are not kindred spirits with respect to state law...

The U.S. Supreme Court and the Kentucky Supreme Court are not kindred spirits with respect to state law restrictions on arbitration agreements....more

Summary Judgment for Concentric Medical on Design Defect and Warnings Claims Related to Fracture of Merci Retriever Device

by Reed Smith on

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the...more

Ransomware Imminently Expected to Target Medical Devices

by Baker Donelson on

As a wave of devastating ransomware-based attacks spread across the globe last week, it became abundantly clear that the medical industry at large was ill-prepared for the threat despite years of warnings. The virus hit...more

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