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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.…

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”). …

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. …

ACA SMALL BUSINESS EXCHANGES DELAYED

On Thursday, September 26, 2013, U.S. Department of Health and Human Services (HHS) announced that it would delay online enrollment in the health insurance exchanges for small businesses. However, applicants may still enroll by phone, mail or fax starting October 1, 2013. Coverage will start January 1, 2014. …

Self-insured employer health plans, whether administered by the sponsor or by a third party administrator (TPA), need to be in compliance with the amended HIPAA rules, effective September 23, 2013. That date has now passed and not all employers with self-insured plans are aware of their obligations or have fully complied. …

PROPOSED RULE ON EMPLOYER INFORMATION REPORTING REQUIREMENTS

On September 5, 2013, the U.S. Department of the Treasury and Internal Revenue Service jointly issued proposed regulations implementing the Affordable Care Act’s information reporting requirements for insurers and certain employers. …