certification criteria

(5) Certification (A) In general The National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this part. Such program shall include, as appropriate, testing of the technology in accordance with section 17911(b) of this title . (B) Certification criteria described In this subchapter, the term “certification criteria” means, with respect to standards and implementation specifications for health information technology, criteria to establish that the technology meets such standards and implementation specifications. (C) Health information technology for medical specialties and sites of service (i) In general The National Coordinator shall encourage, keep, or recognize, through existing authorities, the voluntary certification of health information technology under the program developed under subparagraph (A) for use in medical specialties and sites of service for which no such technology is available or where more technological advancement or integration is needed. (ii) Specific medical specialties The Secretary shall accept public comment on specific medical specialties and sites of service, in addition to those described in clause (i), for the purpose of selecting additional specialties and sites of service as necessary. (iii) Health information technology for pediatrics Not later than 18 months after December 13, 2016 , the Secretary, in consultation with relevant stakeholders, shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of children. Not later than 2 years after December 13, 2016 , the Secretary shall adopt certification criteria under section 300jj–14 of this title to support the voluntary certification of health information technology for use by pediatric health providers to support the health care of children. (D) Conditions of certification Not later than 1 year after December 13, 2016 , the Secretary, through notice and comment rulemaking, shall require, as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph, consistent with other conditions and requirements under this subchapter, that the health information technology developer or entity— (i) does not take any action that constitutes information blocking as defined in section 300jj–52(a) of this title ; (ii) provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take any action described in clause (i) or any other action that may inhibit the appropriate exchange, access, and use of electronic health information; (iii) does not prohibit or restrict communication regarding— (I) the usability of the health information technology; (II) the interoperability of the health information technology; (III) the security of the health information technology; (IV) relevant information regarding users’ experiences when using the health information technology; (V) the business practices of developers of health information technology related to exchanging electronic health information; and (VI) the manner in which a user of the health information technology has used such technology; (iv) has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without special effort through the use of application programming interfaces or successor technology or standards, as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws; (v) has successfully tested the real world use of the technology for interoperability (as defined in section 300jj of this title ) in the type of setting in which such technology would be marketed; (vi) provides to the Secretary an attestation that the developer or entity— (I) has not engaged in any of the conduct described in clause (i); (II) has provided assurances satisfactory to the Secretary in accordance with clause (ii); (III) does not prohibit or restrict communication as described in clause (iii); (IV) has published information in accordance with clause (iv); (V) ensures that its technology allows for health information to be exchanged, accessed, and used, in the manner described in clause (iv); and (VI) has undertaken real world testing as described in clause (v); and (vii) submits reporting criteria in accordance with section 300jj–19a(b) of this title . (E) Compliance with conditions of certification The Secretary may encourage compliance with the conditions of certification described in subparagraph (D) and take action to discourage noncompliance, as appropriate.

Source

42 USC § 300jj-11(c)(5)


Scoping language

In this subchapter
Is this correct? or