Massachusetts council releases draft disclosure regulations
Device Regulation Alert: Safety, Compliance and Reimbursement News, December 15, 2008
The Massachusetts Public Health Council released a draft of regulations regulating medical device manufacturers’ sales and marketing practices, and the disclosure of fees, payments, and other compensation by companies to healthcare providers, according to a PHC press release.
Healthcare providers will not have to disclose payments for research and clinical trials. Massachusetts Department of Public Health Commissioner John Auerbach said the regulations seek to promote transparency of industry financial relationships with healthcare professionals and recognize the important and legitimate research occurring in the state.
Massachusetts is currently the only state to require disclosures by medical device companies, and is the first state to define its own code of conduct that sets out guidelines for the interaction between Massachusetts healthcare professionals and industry representatives.
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