|
|
| Regulation, Specification, or Guidance
|
Requirement
|
| CDC PHIN Messaging System
|
22.1 The system should be capable of interfacing with the Centers for Disease Control and Prevention's (CDC's) PHIN Messaging System.
|
ACMG Technical Standards for Clinical Genetics Laboratories G1.5
|
22.2 The system should support Human Genome Variation Society (HGVS) nomenclature and terminology for sequence variants.
|
| CLSI QMS22 2.1.2.3
|
22.3 The system should be able to collect sufficient test utilization information to make necessity checks on ordered tests against established benchmarks.
|
| ONC USCDI v2
|
22.4 The system should support the United States Core Data for Interoperability (USCDI) v2 standard, which in turn supports data interoperability across multiple clinical settings.
|
| CDC Immunization Information System (IIS) Functional Standards, v4.1, 8.1–8.3
|
22.5 The system should support Simple Object Access Protocol (SOAP), Web Services Definition Language (WSDL), Health Level 7 (HL7), and other data transport and exchange solutions endorsed by the CDC, which in turn supports data interoperability across multiple clinical settings and health information systems, including immunization information systems (IISs), electronic health records (EHRs), and laboratory information systems (LISs).
|
| 45 CFR Part 171
|
22.6 The system should be developed without any information blocking practices—practices likely to interfere with the access, exchange, or use of electronic health information—knowingly implemented into the system.
|
