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Edwards Wildman Palmer LLP New York, NY Document Search Results (33)

 

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HTMLFDA: Industry Must Address Cybersecurity Risks for Medical Devices.
Theodore P. Augustinos, Sharon A. Blinkoff, Ellen Marie Giblin, Mark E. Schreiber, David S. Szabo; Edwards Wildman Palmer LLP;
Legal Alert/Article
October 16, 2014, previously published on October 2014
On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The purpose of the guidance is to encourage manufacturers to consider possible cybersecurity risks while...

 

HTMLMassachusetts Finalizes Risk-Bearing Provider Organization Regulations
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
August 25, 2014, previously published on August 2014
On August 15, 2014, the Massachusetts Division of Insurance (the “Division”) released the final regulations implementing Chapter 176T of the Massachusetts General Laws (“Chapter 176T”).

 

HTMLFinal Meaningful Use Regulations under Review by OMB
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
August 25, 2014, previously published on August 2014
On August 8, 2014, the White House Office of Management and Budget (OMB) received the final rule addressing the meaningful use stage timeline, the definition of certified electronic health record technology (CEHRT), and the requirements for the reporting of clinical quality measures for 2014. The...

 

HTMLMassachusetts Bans Physician Self Referral to Clinical Labs; Healthfirst Case May Help Clarify 60-Day Rule
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 31, 2014, previously published on July 2014
Massachusetts physicians can no longer refer Medicaid and private pay patients to clinical laboratories in which they or a family member have a direct or indirect ownership interest. The provision was included in the commonwealth’s 2015 budget bill. Governor Deval Patrick signed the budget on...

 

HTMLCMS Proposes Changes to the Home Health Face-to-Face Encounter Requirement
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 21, 2014, previously published on July 2014
On July 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule updating the Home Health Prospective Payment System (“HH PPS”) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the...

 

HTMLFDA Issues Draft Guidance for Medical Device Data Systems
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 1, 2014, previously published on June 2014
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance to inform manufacturers, distributors, and other entities that FDA does not intend to enforce compliance with the agency’s 2011 regulations governing medical device data systems (MDDS) subject to 21 CFR...

 

HTMLSupreme Court Reconciles Federal Circuit Diverse Views on Patent Eligibility of Computer Implemented Inventions
Dev Batta, Rory J. Radding; Edwards Wildman Palmer LLP;
Legal Alert/Article
June 24, 2014, previously published on June 2014
The Supreme Court has tried to quiet the debate on what is patent eligible. They have now recognized that fundamental economic practices are not patent eligible if they are merely implemented on a computer without additional features as well as that computers are ubiquitous now so wholly generic...

 

HTMLWhite House Supports Current Cybersecurity Rules
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
May 30, 2014, previously published on May 2014
The Obama Administration recently announced that it allow HHS to continue its efforts to mitigate cyberrisk. Last year, President Obama issued Executive Order (EO) 13636, “Improving Critical Infrastructure Cybersecurity,” which required HHS and other Executive Branch agencies to assess...

 

HTMLOIG Proposed Rules Would Expand Civil Monetary Penalty Authority and Exclusion Authority
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
May 30, 2014, previously published on May 2014
On May 12, 2014, the HHS Office of Inspector General (OIG) published a proposed rule implementing the new civil monetary penalty (CMP) authorities provided under the Affordable Care Act.

 

HTMLAHA Sues over Delays in Appeals Process
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
May 30, 2014, previously published on May 2014
On May 22, 2014, the American Hospital Association (AHA) and three member hospitals filed a lawsuit against Secretary Kathleen Sebelius, in her capacity as the Secretary of the U.S. Department of Health and Human Services (HHS), in the U.S. District Court for the District of Columbia to compel HHS...

 


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