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

Edwards Wildman’s latest healthcare advisory “Senate Passes Post-Acute Care Reform Bill; OIG Issues Special Advisory Bulletin on Drug Copayment Coupons” discusses legislation passed that was intended to strengthen and improve the Medicare post-acute care system.
Read More Healthcare Update: Senate Passes Post-Acute Care Reform Bill; OIG Issues Special Advisory Bulletin on Drug Copayment Coupons

Edwards Wildman’s David Szabo, partner, in the Healthcare Practice Group discusses “Reminder: Update Your “Grandfathered” Business Associate Agreements By September 23, 2014” and “Final Meaningful Use Regulations Published” …
Read More Healthcare Update: Reminder: Update Your “Grandfathered” Business Associate Agreements By September 23, 2014; Final Meaningful Use Regulations Published

Massachusetts health officials announced last week that it will replace its health insurance exchange website. According to media reports, the current website has had difficulty implementing the federal health laws (i.e., Obamacare), because it was designed to comply with state health laws (i.e., Romneycare). …
Read More Massachusetts to Replace Health Exchange Website Provider

Edwards Wildman’s Lori Basilico, partner in the Healthcare Practice Group discuss “U.S. House of Representatives Passes Bill to Redefine Full-Time Employee Under the Affordable Care Act.” …
Read More Healthcare Update: U.S. House of Representatives Passes Bill to Redefine Full-Time Employee Under the Affordable Care Act

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”). …
Read More Live Blog: Emerging Accounting Issues Working Group & Statutory Accounting Principles Working Group Meeting

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. …
Read More Healthcare Update: FDA Releases Guidance on Mobile Medical Applications

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. …
Read More Healthcare Update: ACA Small Business Exchanges Delayed; Two-Midnight Admission Policy Goes Into Effect

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. …
Read More Employer-Sponsored Health Plans and SEPT. 23 HIPAA DEADLINE: Time for a Tune Up?

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. …
Read More Healthcare Update: Proposed Rule on Employer Information Reporting Requirements; Potential Fix for the “Doc Fix”