Topic: Healthcare

Healthcare Update: OIG Proposed Rule Would Amend Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules; CMS Launches Open Payments Database

Edwards Wildman’s latest Healthcare Update discusses that the Office of Inspector General (“OIG”) published a proposed rule that would amend the safe harbors to the anti-kickback statute (“AKS”) and the civil monetary penalty (“CMP”) rules under the authority of the OIG; and how CMS launched open payments database on September 30, 2014.

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Healthcare Update: FDA: Industry Must Address Cybersecurity Risks for Medical Devices

Edwards Wildman’s latest Healthcare Update discusses the FDA’s final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks.

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Live Blog: Emerging Accounting Issues Working Group & Statutory Accounting Principles Working Group Meeting

On Saturday, March 29th, 2014, the Emerging Accounting Issues Working Group & Statutory Account Principles Working Group held a meeting to adopt certain standards and to expose other proposals for comments. The sole topic of substantial debate surrounded moving forward with the Accounting for the Risk Sharing Provisions of the Affordable Care Act (the “Act”). 

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Healthcare Update: FDA Releases Guidance on Mobile Medical Applications

On September 25, 2013, the U.S. Food and Drug Administration (“FDA”) released final guidance on how it intends to regulate mobile applications (“apps”). The guidance consists of a set of nonbinding recommendations that define what mobile apps meet the definition of a medical device and are therefore subject to FDA’s regulation as medical devices and what mobile apps fall outside the definition of a medical device. 

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