Nuts-n-Bolts of Product Testing and Certification Session #112, March 7, 2018 Steven Posnack MS MHS, Dir. Office of Standards and Technology, ONC, US

Transcription

1 Nuts-n-Bolts of Product Testing and Certification Session #112, March 7, 2018 Steven Posnack MS MHS, Dir. Office of Standards and Technology, ONC, US Dept of Health and Human Services John Donnelly MS MBA, President, IntePro Solutions Inc. 1

2 Conflict of Interest Steven Posnack MS MHS John T. Donnelly MS MBA Have no real or apparent conflicts of interest to report. 2

3 Agenda ISO-accredited Public Sector Testing and Certification Program ONC Product Testing Programs from IHE and Other Standards Organizations ISO-accredited Private Sector Testing and Certification Program ConCert by HIMSS 3

4 Learning Objectives Recognize the characteristics of an ISO-accredited HIT product testing and certification program Understand the HIT product testing continuum and its relationship to the ONC CEHRT and ConCert by HIMSS programs Identify the similarities and differences between the ONC (public sector) and HIMSS (private sector) operated testing and certification programs Understand the relationship between the IHE International Conformity Assessment program and the ConCert by HIMSS program Assess how and where to become more engaged with the testing requirements development process and their inclusion in the public and private sector programs 4

5 Big Picture 5

6 Testing Components Test Procedures Test Tools Test Data Principally have been government-led and developed 6

7 Evolving the Program s Testing Portfolio July 2015 Reminder about private sector s ability to submit testing artifacts October 2015 Interoperability Roadmap Released June 2017 Approved NCQA s alternative testing method August 2017 Announced a 5-year goal to transition testing portfolio October 2017 Approved HIMSS-IIP alternative testing method February 2018 Approved NCQA as an ONC-ATL Ongoing engagement with private sector 7

8 21 st Century Cures Calls for new conditions of certification Apply to health IT developers (v) has successfully tested the real world use of the technology for interoperability (as defined in section 3000) in the type of setting in which such technology would be marketed; 8

9 Industry Program Offerings Some programs based on ISO/IEC (for Testing) and/or ISO/IEC (for Certification) Leverage a testing and tools ecosystem made operational via extensive tool set adopted (not developed) by the program

10 Testing Continuum 10

11 General Concepts in ISO Certification Scheme Owner Certificates Issued Accreditation Body Assessment Accreditation Body Accredits ISO/IEC Accredits ISO/IEC Accredited Certification Body Application Report (Results and Attestations) Accredited Testing Laboratory Application Vendor Evaluation Certificate 11

12 Opportunities for Private Sector Engagement Product Certification to Expedite HIE Onboarding Private-sector programs to compliment ONC activities Joint program of IHE, HIMSS, EHR HIE Interop Workgroup More than DIRECT, and more than EHR Potential integration with CHC/HIMSS Immunization Integration Program Additional program for Medical Device certification Diverse Advisory Committee to set future priorities Personal Connected Health Alliance (PCHA) Joint program of IEEE, IHE, HIMSS, Continua Focus on medical device, home hubs; i.e. outside physician practice HIT and their exchange with EHR s 12

13 Opportunities for Private Sector Engagement Direct Feedback to Shape Testing/Certification Tooling and Deliverables Pilot programs with HIT product vendors to validate test tools prior to production roll-out Open forums to set success criteria and functionality priorities Participation in Standards Development Organization(s) domains and workgroups Engagement of care provider user community in process as early as possible, e.g. HL7 FHIR Community Forums 13

14 4 Distinct Certifications for EHR systems providing a simplified way for providers to send secure health information directly to trusted recipients for HIE systems that enable clinicians to share health information within and across care delivery communities 14 for Health Information Services Provider systems to send secure health information directly to trusted recipients, including patients for medical devices and EHR systems to provide a standardized way to exchange programming order information and clinical information at the point of care

15 IHE International Conformity Assessment IHE-CA program was launched in 2015 and is the next step in testing rigor It is based on an internationally recognized quality system Testing for specific IHE Profiles is performed by Testing Laboratories ISO/IEC accredited Conformity Assessment Reports are published on the IHE International website on successful completion of testing see: Project and country specific Certification programs (e.g. ConCert by HIMSS ) may easily recognize and build upon IHE Conformity Assessment 15

16 ConCert IHE-CA Relationship 16

17 ConCert IHE-CA Relationship Profile Alignment Between Programs For sharing health records Direct SMTP, XDR, XDS.b, ATNA, PIX/PIXV3, PDQ/PDQV3, XCA, XUA For Hospitals, HIS, lab and ICUs PAM (ITI), DEC, PIV (PCD) For sharing health records XDS.b, ATNA, PIX/PIXV3, PDQ/PDQV3, XCA, XUA, XCPD (ITI), XDS-I, XCA-I (RAD) For Hospitals, HIS, lab and ICUs PAM (ITI), DEC, PIV (PCD), LAW (PaLM) 17

18 DEC Profile (Device to Enterprise Communications) The PCD-DEC (Device to Enterprise Communications) profile allows a consuming system (DOC) to receive patient clinical information including vitals, demographics, settings, and location from a reporting device/system (DOR). *Slide Content developed by IHE and the PCD Technical Committee 18

19 PIV Profile (Point-of-Care Infusion Verification) The PCD-PIV (Point-of- Care Infusion Verification) profile supports the electronic transfer of infusion parameters from a Bedside Computer-assisted Medication Administration (BCMA) system or EMR to a general-purpose infusion pump, enhancing patient safety by effectively eliminating keystroke errors. *Slide Content developed by IHE and the PCD Technical Committee 19

20 On the road to st Century Cures Act maximize collaboration between ONC and ConCert by HIMSS program regarding Alternate Test Method opportunities Options Simplification explore harmonization / reciprocity between ConCert by HIMSS and other private sector programs in the USA (Sequoia Project, PCHA, NCQA, etc) Operational Simplification continue harmonization with IHE International CA Steering/Advisory Committee processes and timelines alignment Testing tool integration and operational simplification Cyber Security Validation near term, attestation report; future, formal cybersecurity and IoT testing and validation New Standards Recognition inclusion of testing/certification of FHIR based functionality in HIT products 20

21 Questions?? Further Info: Steven Pasnack, John Donnelly, IHE CA program information ConCert by HIMSS information Please Complete Online Session Evaluation 21