On February 15, 2011, the Food and Drug Administration ("FDA") published a final rule reclassifying Medical Device Data Systems ("MDDS") as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defined MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications, or display "medical device data." FDA explicitly excluded electronic health record ("EHR") and computerized physician order entry ("CPOE") systems from the MDDS Final Rule. Because MDDS do not "provide new or unique algorithms or functions," FDA concluded that general controls, such as the Quality System Regulations are sufficient to mitigate any risks associated with MDDS.… Continue Reading
Earlier today the Department of Health and Human Services’ (HHS), Office for Civil Rights (OCR) announced the imposition of the first ever civil money penalty for violations of the HIPAA Privacy Rule. The penalty – which is $4.3 million – was assessed against Cignet Health of Prince Georges County, a health insurer. The underlying HIPAA … Continue Reading
Law360 is reporting that Rep. Jerrold Nadler (D-NY) is seeking to revive the 2009 "Sunshine in Litigation Act," a bill we covered previously. H.R. 592 would turn around the Supreme Court's Seattle Times Co. v. Rhinehart, 467 U.S. 20, 33 (1984), which concluded that discovery materials are not public components of a civil trial. As a result, litigation protective orders are permissible to protect the confidential and proprietary information of parties to civil litigation, at least until information produced in discovery is filed with the court or introduced into evidence for determination of a merits issue (such as on a motion for summary judgment or at trial.… Continue Reading
