On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
CMS Delays ICD-10 Deadline
In a final rule issued in 2009, HHS adopted the ICD-10 code sets as the HIPAA standards. The code sets provided an update to the Official ICD-9-CM Guidelines for Coding and Reporting in place at the time, and included additional codes for new procedures and diagnoses. The 2009 final rule established October 1, 2013 as the deadline for compliance with the new code sets. The newly issued final rule delays the compliance date until October 1, 2014.
The final rule adopts two standard identifiers for use in Health Insurance Portability and Affordability Act of 1996 (HIPAA) standard transactions. The HPID is a standard unique identifier for health plans. The rule will require all covered entities to use HPIDs when the covered entity identifies a health plan in a covered transaction. The rule also adopts a data element as an other entity identifier (OEID). OEIDs will be used as identifiers for entities that are not health plans, health care providers or individuals. CMS anticipates that these changes will simply paperwork for providers and estimates that the changes will save up to $6 billion over ten years. This regulation will take effect 60 days after publication in the Federal Register, which is scheduled for September 5, 2012.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017