Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Reed Smith
CMS has issued a proposed rule that would allow organizations approved as "qualified entities" to confidentially share or sell analyses of Medicare and private-sector claims data to providers, employers, and other groups who can use the data to support improved care.
Reed Smith
The CMS Office of Minority Health has released a "Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries."
Mayer Brown
On January 26, 2016, the US Food and Drug Administration (FDA) issued draft guidance entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
Reed Smith
On February 2, 2016, the House failed to muster the votes needed to override President Obama's veto of H.R. 3762, the "Restoring Americans' Healthcare Freedom Reconciliation Act."
BakerHostetler
As we look into the rearview mirror a final time, we're reminded that so many of the issues addressed by the top reads of 2015 will undoubtedly continue to be of interest this year!
Morgan Lewis
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity.
Reed Smith
On February 9, 2016, President Obama is scheduled to submit his proposed fiscal year 2017 budget to Congress.
Reed Smith
President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment.
Day Pitney LLP
Eric Fader wrote an article, "A New Era Of Health Care Privacy And Security Enforcement," for Law360.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Recent enforcement actions by the U.S. Department of Health and Human Services Office for Civil Rights have highlighted that, not surprisingly, Covered Entities should not leave medical records in a physician's driveway...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered salmon until such a time as comprehensive labeling guidelines are introduced.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Mintz Levin's Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana's Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act and its implementation.
BakerHostetler
As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response.
Duane Morris LLP
In Universal Health Services Inc. v. U.S. et al. ex rel. Escobar et al., case number 15-7, the U.S. Supreme Court will decide the viability and scope of the "implied certification" theory of liability under the False Claims Act.
Reed Smith
The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks.
Morgan Lewis
The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Today, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under Medicare.
Foley Hoag LLP
On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law...
Thompson Coburn LLP
Under standard cyber security/network security/privacy liability insurance policies (otherwise known as cyber risk insurance), are insureds covered for reasonably incurred costs to mitigate or avoid harm...
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
These fifteen finalists are then invited to the Awards Night on April 6 at Mintz Levin's Boston office where they will all have Poster presentations.
Dickstein Shapiro LLP
Success in the Emerging Asian Markets (EAMs) requires medical device companies to ensure superior product and patent protection for both their products and related methods of use...
Thompson Coburn LLP
It comes as no surprise that virtually every postsecondary administrator is familiar with the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. ง 1232g; 34 CFR Part 99).
Thompson Coburn LLP
Under standard cyber security/network security/privacy liability insurance policies (otherwise known as cyber risk insurance), are insureds covered for reasonably incurred costs to mitigate or avoid harm...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called "Internet of Things."
Poyner & Spruill LLP
Like it or not, the Centers for Medicare & Medicaid Services (CMS) is expanding its strong commitment to focus on quality and care improvement as the basis for payment throughout the continuum of care.
Fisher & Phillips LLP
Employers started 2016 by claiming another victory in the ongoing battle against medical marijuana in the workplace.
BakerHostetler
As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response.
Thompson Coburn LLP
The final regulations on the Affordable Care Act's (ACA) "pay or play" rules were released on Feb. 10, 2014.
Duane Morris LLP
In Universal Health Services Inc. v. U.S. et al. ex rel. Escobar et al., case number 15-7, the U.S. Supreme Court will decide the viability and scope of the "implied certification" theory of liability under the False Claims Act.
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