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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...

 

HTMLFinal Meaningful Use Regulations Published
Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
September 19, 2014, previously published on September 2014
On September 4, 2014, the U.S. Department of Health and Human Services, the Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC) published in the Federal Register a final rule on meaningful use. Significantly, the...

 

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...

 

HTMLSEC Modifies Municipalities Continuing Disclosure Cooperation Initiative and Delays Deadline for Issuers and Obligors
Mark-David Adams, Walter J. St. Onge; Edwards Wildman Palmer LLP;
Legal Alert/Article
August 4, 2014, previously published on August 1, 2014
On July 31, 2014, the Securities and Exchange Commission (the “SEC”) announced modifications to its Enforcement Division’s Municipalities Continuing Disclosure Cooperation Initiative (“MCDC Initiative”). The SEC expects that its changes will provide greater opportunity...

 

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...

 

HTMLSEC Provides Helpful Guidance on Accredited Investor Verification
Stacie Sawchak Aarestad, Matthew C. Dallett, Stanley Keller, Eugene W. McDermott; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 14, 2014, previously published on July 2014
On July 3, 2014, the staff of the SEC’s Division of Corporation Finance issued guidance on reasonable steps to verify the accredited investor status of purchasers for purposes of the Rule 506(c) exemption that permits general solicitation. The guidance, which is in the form of several...

 

HTMLMicrosoft and Other Major Technology Companies Push Back Against Warrant to Access Data Held on Foreign Servers
Lawrence R. Freedman, Ari Z. Moskowitz, Mark E. Schreiber; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 1, 2014, previously published on June 26, 2014
A dispute between Microsoft and the U.S. government over a search warrant could have major repercussions for cloud service providers. Historically, European data privacy and protection standards have been stricter generally speaking than those in the U.S. The "Safe Harbor" arrangement...

 

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...

 


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