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Results 1 to 5 of 31



New HIPAA Audit Process to Expose Many Healthcare Providers and Vendors to Enforcement

USA - June 2 2016 The Office for Civil Rights (OCR) of US Department of Health & Human Services is initiating an auditing process to evaluate compliance with…


BREAKING: Deal Reached on New EU Medical Device and IVD Regulations

European Union - May 26 2016 On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the…

Co-authors: Sarah H. Stec.


FDA Considers Regulating Refurbishers and Other Third Parties

USA - March 8 2016 The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device…

Co-authors: Sarah H. Stec.


FDA Announces Commitment to MDSAP

USA - January 20 2016 The US Department of Health and Human Services, Food and Drug Administration (FDA) announced on December 17, 2015, that it would participate in the…

Co-authors: Sarah H. Stec.


FDA Issues Draft Guidance on “Emerging Signals”

USA - January 19 2016 On December 31, 2015, FDA announced the availability of the draft guidance document, Public Notification of Emerging Postmarket Medical Device…

Co-authors: Sarah H. Stec.

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