Re: [bcm] BCM EPR proposed work effort

["EPR: Hans A. Kielland Aanesen" <hans@eprforum.no>]

Hi Carl,

That fits also well with the ANSI/CEA fuctional modelling standard transfer to EPR-forum.

See http://www.eprforum.no/news.php/EPR-eDevice-ANSICEA-standards-transfer-to-EPR-forum/1/28/

 

EPR-forum is in the process to sign an agreement with both Drammen and Oslo County.

See attached slideshow used in this process (partly translated)!

 

Best regards
Hans A. Kielland Aanesen
CEO EPR-forum
Senior Advisor Transformational Government Framework (TGF and eGov 2.0)
Advancing an overall framework for using IT to improve the delivery of public services

 

Mobile: +47 40291180

 

Member of OASIS ( http://www.oasis-open.org ) and OASIS eGov MS ( http://www.oasis-egov.org )
Co-founder of EPR-forum ( http://www.eprforum.no ) and the PSQA alliance (Public Supervision & Quality Assurance)
Co-chair OASIS BCM-EPR SC
Contributor and voting member OASIS TGF TC, BCM TC and CAM TC
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OASIS BCM and CAM has been international SOA standards opening up an enormous potential of new services

----- Original Message -----

From: carl mattocks

To: bcm@lists.oasis-open.org

Sent: Thursday, February 17, 2011 4:01 PM

Subject: [bcm] BCM EPR proposed work effort

Now that the FDA has issued a regulatory statement on classification of Medical systems , please consider if it is now time to define a  BCM EPR work effort for this space

FDA's examination of modern medical device networks and computer infrastructures, informs this reclassification of a category of postamendment computer and software devices that can be regulated under a single classification. This medical device has been named a “Medical Device Data System” or “MDDS.” Because an MDDS does not provide new or unique algorithms or functions, FDA has determined that applying general controls, such as the Quality System regulation (QS regulation or QS requirements) (part 820 (21 CFR part 820)), to the design and development of these devices will provide sufficient regulatory control to mitigate any associated risks. Accordingly, FDA is classifying the MDDS into class I.

https://www.federalregister.gov/articles/2011/02/15/2011-3321/medical-devices-medical-device-data-systems

please comment ..

thanks

Carl Mattocks
--
CEO CheckMi
Chair OASIS BCM Tech Committee
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Cell (usa) (732) 497-CARL {2275}
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OASIS BCM-EPR eHealth ref.pdf