Mondaq All Regions: Food, Drugs, Healthcare, Life Sciences
Holman Webb
E-health, cybersecurity, privacy, duty of care and the obligation to follow-up are all relevant issues to be considered.
Minden Gross LLP
Matt Maurer was quoted in "Growing like weed" on the legalization of cannabis and some of​ the difficulties that ​accompany these ​changes. The article was published on May 17, 2017 by Listed Magazine.
Ropes & Gray LLP
On May 19, 2017, China's State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices ("the Amendments"), which became effective immediately.
Clyde & Co
Correia v University Hospital of North Staffordshire NHS Trust [2017] EWCA Civ 356.
Deloitte
Last week marked both Mental Health Awareness Week and Dying Matters Awareness Week.
Morgan Lewis
The last six years have been a wild ride for telehealth providers in Texas. When the TMB issued emergency rules in 2011 that required either a preexisting relationship or the presence of a...
McDermott Will & Emery
Most brewers are at least somewhat familiar with federal and state laws regulating the interrelationships between members of the different industry tiers.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) is delaying until January 1, 2018 implementation of mandatory Medicare episode payment models (EPMs) for acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment procedures furnished in designated geographic areas.
Womble Carlyle
Protection and Advocacy for People with Disabilities, Inc., (P&A) and six individuals with disabilities have filed a class action lawsuit against the South Carolina Department of Mental Health (DMH)...
BakerHostetler
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...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Our ML Strategies colleagues have published a preview for another big week in health care.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
CMS implemented the controversial guidance as a final rule in October 2016.
Reed Smith
Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case.
Wilson Elser Moskowitz Edelman & Dicker LLP
This article discusses the risks associated with use of an MSO and advises structuring such arrangements to comply with the Anti-Kickback Statute's personal services/management safe harbor.
BakerHostetler
The DOJ's 39-page complaint alleges that United had fraudulently obtained inflated risk adjustment payments by over reporting diagnosis codes for MA beneficiaries since 2005.
BakerHostetler
The use of efficiencies as a defense remains without a firm footing in law when a transaction has demonstrable and substantial anticompetitive effects.
BakerHostetler
Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee...
Baker Sterchi Cowden & Rice LLC.
The old adage "location, location, location" applies as much for medical device preemption as it does for real estate.
Crowell & Moring
In an Interim Final Rule with Comment Period (IFC) published on March 21, 2017, CMS provided that implementation of the EPMs for cardiac and orthopedic care improvement, the cardiac rehabilitation incentive payment model, and the changes to the Comprehensive Care for Joint Replacement (CJR) model would be delayed from July 1, 2017 to October 1, 2017.
Parker Poe
The letter lists a host of state-led reforms to better align Medicaid with private insurance policies, including health savings account-like features.
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Ropes & Gray LLP
This article highlights key business and legal issues related to value-based healthcare for investors considering opportunities in the healthcare industry.
Mayer Brown
On December 22, 2016, a dispute settlement panel established by the World Trade Organization (WTO) issued its report in Indonesia – Import Licensing (DS477/DS478)...
Ropes & Gray LLP
These documents represent a final attempt by the outgoing Administration to impact the agency's regulatory approach going forward.
McDermott Will & Emery
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Akin Gump Strauss Hauer & Feld LLP
On December 27, 2016, the U.S. Court of Appeals for the 10th Circuit ruled 2­1 that the SEC's process for hiring administrative­-law judges violates the Appointments Clause of the U.S. Constitution.
Cassels Brock
Although the United States government's attitudes toward cannabis have eased in recent years, the election of President Donald Trump has generated renewed uncertainty....
Deloitte
The pharmaceutical industry continues to face regulatory and reimbursement hurdles weighing on the research and development returns of pharmaceutical firms this year.
Norton Rose Fulbright Canada LLP
Global M&A activity in the biopharmaceutical industry skyrocketed in 2014 and 2015, eclipsing US$200 billion in deal value each year and prompting EY to declare such elevated activity...
Singh & Associates
The Uniform Code of Pharmaceuticals Marketing Practices, 2014 ("UCPMP Code") is a voluntary code issued by the Department Of Pharmaceuticals ("the Department") relating to marketing...
Day Pitney LLP
An article in For the Record magazine entitled "Call In the Reinforcements" discussed what healthcare organizations must do to be prepared to respond in the event they suffer a data breach.
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