Reed Smith attorneys
Jason Casell and
Steve Miller will be moderating and presenting respectively on
the "Pharmaceutical and Medical Devices Industries
Update" panel on November 10, 2016 at DRI's Government
Enforcement and Corporate Compliance Seminar.
This panel will examine recent government enforcement activities
and legal decisions that might shape investigations, litigation,
and resolutions of government claims. The criminalization of
pharmaceutical and medical device FDA disclosure violations will
also be addressed.
The DRI event will be held from November 10 to November 11 at
the National Press Club, 529 14th Street, NW, 13th Floor
Washington, DC 20045.
Other seminar sessions include:
The Foreign Corrupt Practices Act and Anti-Corruption
Data Breach: New Technology, New Challenges, New Risks
Health Care Fraud: Riding the Wave
Special Address: A Veteran's Perspective on Key Principles
of Professional and Personal Success
Anti-Money Laundering and Bank Secrecy Act
Special Address: Perspectives from a Federal Prosecutor
When the Client Is in the Crosshairs: Strategies for Responding
to Government Investigations
Global Antitrust Enforcement
A False Claims Act Case Study
Environmental Dangers: Compliance and Ethics in Environmental
For full information on this informative DRI seminar or to
register, please visit the event's website. In-house counsel who
are DRI members receive complimentary registration.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
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.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
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