| References |
|
| Contents |
|
| 1 | Objective | | 1.1 | The objective of this notice is to inform all certification bodies that are accredited by ANSI for ONC Health IT Certification Program scope on how to address a certified vendor request to be certified by an alternative accredited certification body. | | 2 | Definitions | | None | | 3 | Effective Date | | November 29, 2016 | | 4 | Notice | | 4.1 | There are no ONC Health IT Certification Program scheme requirements that address the process a certification body's client to cease business, with the intent to start business to be certified by an alternate accredited certification body. | | 4.2 | Therefore, the ANSI-Accredited Certification Body shall address this situation in accordance with ISO/IEC 17065. As defined in ISO/IEC 17065, to accept the test results related to the EHR platform, the alternate certification body must sign an agreement with an NVLAP-accredited laboratory that tested the software platform - 17065 clause 6.2.2.3. | | 4.3 | The alternate certification body must also review that the clients are in compliance with the most current ONC regulation as needed in (h)(1). ANSI also expects the alternate CB to review: | | a) | client marketing (website & brochures) 170.523(k)(1); | | b) | transparency attestations 170.523(k)(2); | | c) | use of Certification Marks 170.523(l);
| | d) | verify that the activities performed by the issuing CB conformed to the requirements in ISO/IEC 17065 and the ONC certification scheme; and
| | e) | verify that the client is not under a Program Ban. | | 4.4 | Additionally, developers with product certification(s) which have been suspended or under threat of suspension, withdrawn or terminated shall not be assessed for certification by the alternate certification body. If the alternate certification body has not been able to verify the status of the certification with the issuing certification body, the organization shall be required to confirm that the certificate is not suspended or under threat of suspension, withdrawn or terminated. | | 4.5 | For further information, contact Reinaldo Figueiredo (rfigueir@ansi.org).
|
|