Certification/Adoption Workgroup HIT Policy Committee April 7, 2014

1. Certification/Adoption WorkgroupHIT Policy CommitteeApril 7, 2014 Discussion of 2015 Ed. NPRM

2. ONC Certification Mark • Currently, ``ONC Certified HIT'' certification and design mark, as used by an authorized user, certifies that a particular HIT product has been tested in accordance with test procedures approved by the National Coordinator; has been certified in accordance with the certification criteria adopted by the Sec’y; and has met all other required conditions of the ONC HIT Certification Program. • Proposal: • to require ONC-ACBs to display the Mark on all certifications issued under the ONC HIT Certification Program in a manner that complies with the ‘Criteria and Terms of Use’ • to revise Sec. 170.523 to require ONC-ACBs to ensure that use of the Mark by HIT developers whose products are certified under the ONC HIT Certification Program is compliant with the Terms of Use

3. Non-MU EHR Technology Certification • Propose to amend regulatory requirements to support certification for technology used for purposes other than MU. • MU and Non-MU certified technology would be easily distinguishable. • Specifications: • Create an MU EHR Module definition and non-MU EHR Module definition. • Only MU EHR Modules would need to be certified to the “automated numerator recording” ((g)(1)), “automated measure calculation” ((g)(2)) and “non-percentage based measure use report” ((g)(5)). • Both MU EHR Modules and non-MU EHR Modules must be certified to “safety-enhanced design” ((g)(3)) and/or “quality system management” ((g)(4)). • (k)(1)(iii) will only apply to MU EHR Modules and distinctions would be listed on CHPL Distinction would not apply retroactively to 2014 Ed., would only apply to 2015 and beyond.

4. Non-MU EHR Technology Certification • Specific Questions: • Is ONC’s regulatory burden assumption correct related to EHR technology developers having to meet the automated numerator and automated measure calculation certification criteria to obtain certification? • Do the automated numerator and automated measure calculation certification criteria requirements pose more of burden for small EHR technology developers that design EHR technology for non-MU purposes and settings (e.g., inhibit their ability to compete with large EHR technology developers that have more resources to develop and get certified to the automated numerator and automated measure calculation certification criteria even if their customers will not use the capabilities)? • Would health care providers using EHR technology for non-MU purposes and settings benefit from or be hindered by paying for and/or using EHR technology certified to the automated numerator and automated measure calculation certification criteria? • How does ONC best implement the proposed approach if ONC were to adopt it in a subsequent final rule. In this regard, ONC requests feedback on the following questions: • Would the process for testing and certification be clear under our approach as described? Should EHR technology developers simply inform ONC-ACBs as to the type of EHR Module certification they seek (i.e., MU or non-MU)? • How should we distinguish non-MU EHR Modules on the CHPL? Should we have separate listings of MU and non-MU EHR Modules? Are there other options? How should we indicate and list the availability of MU EHR Modules for use beyond MU purposes?

5. Non-MU EHR Technology Certification Proposed CAWG response: It is important to be clear about what is a MU vs. non-MU module. We support the optionality embedded in the requirements that MU and non-MU modules must be certified to either the § 170.315(g)(3) (Safety-enhanced design) and/or (g)(4) (Quality system management). This optionality should be retained. We believe that the ONC CHPL should make it very clear to users which modules are MU and which are non-MU EHR modules. We defer to the C/A WG members who are vendors to comment on the regulatory burden assumptions related to EHR technology developers having to meet the automated numerator and automated measure calculation certification criteria to obtain certification and the burden for small EHR technology developers that design EHR technology for non-MU purposes and settings. At this time, we do not believe it is possible comment on the cost impact of technology on health care providers using EHR technology for non-MU purposes and settings. Generally, we believe that removing the automated numerator and automated measure calculation certification criteria could simplify the technology, simplify the user experience, and reduce cost. Yes, EHR technology developers should inform ONC-ACBs as to the type of EHR Module certification they seek (i.e., MU or non-MU). The CHPL should clearly indicate (by check box, for example) whether the module is MU or non-MU certified. In response to the last question, at this time we think it would be premature to indicate and list the availability of MU EHR modules for use beyond MU purposes.

6. Additional Patient Data Collection –2017 Proposal • Question: Should ONC should require the collection and use of certain patient generated data in the 2017 Edition? • Specific Data: • Disability Information and Accommodation Requests • Sexual Orientation and Gender Identity • U.S. Military Service • Work Information-Industry/Occupation • Methods of Inclusion • A 2017 Edition ‘‘demographics’’ certification criterion • New standalone certification criteria for each data element; • New certification criteria together (e.g., disability, sexual orientation and gender identity in one certification criterion with veterans status and occupation status in a separate certification criterion).

7. Additional Patient Data Collection –2017 Proposal • Proposed CAWG response • Separating each data group out into different criteria does not make sense. Include in the demographics criterion. • These should only be included if ONC is committed to inclusion in the Demographics criterion long term. Should not be included if intended to be used as a test, which will waste time and money.

8. Additional Patient Data Collection –2017 Proposal Disability Information and Accommodation Requests Questions Proposed: • Are you deaf or do you have difficulty hearing? If so, what special assistance may you need? • Are you blind or do you have difficulty seeing, even when wearing glasses? If so, what assistance may you need? • Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? (patients 5 years old or older). If so, what assistance may you need? • Do you have difficulty walking or climbing stairs? (patients 5 years old or older) If so, what assistance may you need? • Do you have difficulty dressing or bathing? (patients 5 years old or older). If so, what assistance may you need? • Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor’s office or shopping? (patients 15 years old or older). If so, what assistance may you need? • Do you have difficulty communicating, reading, or do you have limited proficiency in English? If so, what assistance may you need? Request Comment on whether: • These questions are the right questions to ask (with yes/no responses and a field for additional explanation); • These questions and answers can be accurately and efficiently recorded in an EHR; • There are alternative questions that could be asked related to disability status and additional assistance requests; • There are other ways for capturing patients’ needs in EHR technology and patients’ needs related to interacting with EHR technology; and • There are any available standards that could be used to capture in an EHR the listed questions (and answers) or any disability information and accommodation requests in a structured way. For example, would the following standards be appropriate for the associated information or suffice to code the listed questions and answers: • ICF (International Classification of Functioning, Disability and Health) for categories of function; • LOINC® for assessment instruments; and • SNOMED CT® for appropriate responses

9. Additional Patient Data Collection –2017 Proposal • Proposed CAWG response • We should require Disability Information to be collected in 2017, and beyond. • Support proposed questions since they are from classification functioning. Support standardizing the inclusion and response capture as much as possible • Unsure if LOINC or SnowMedCTare good for assessments

10. Additional Patient Data Collection – 2017 Proposal Additional Patient Data Collection –2017 Proposal Sexual Orientation and Gender Identity Request Comment on: • Whether certification should require that EHR technology be capable of enabling a user to electronically record, change, and access data on a patient’s sexual orientation and gender identity. • If so, To which code sets could be used to capture this information in a structured format: • SNOMED CT® for sexual orientation. • SNOMED CT® for gender identity. U.S. Military Service Request Comment on: • Whether certification should require that EHR technology be capable of enabling a user to electronically record, change, and access U.S. Military service information. • Whether the ‘‘U.S. Military service’’ data element should be expanded to encompass all uniformed service members, including commissioned officers of the U.S. Public Health Service and the National Oceanographic and Atmospheric Administration as they too are eligible for veterans benefits and related services. • In terms of electronically capturing U.S. Military service, we request comment on the following: • Use of the following concepts for coding U.S. Military service in EHR technology: History of Employment in U.S. Military; No History of Employment in U.S. Military; and Currently Employed by U.S. Military. • Whether it would be appropriate to capture the actual start date and date of separation from service. • Whether EHR technology should be able to record the foreign locales in which the service member had recently served. • Whether there are better concepts/ values that could capture information related to U.S. Military status or uniformed service status, including through capturing occupational status and use of occupational code sets.

11. Additional Patient Data Collection –2017 Proposal • Proposed CAWG response • SOGI • Support using codes that are more inclusive than MFU in order to properly identify members of the LGBT population. This data will support disparities and other research. • Unsure which code set is proper to use. • Military Service • Support identifying service members, as well as the dates served and location of service. This data collection will help identify potential medical diagnosis and is required by other programs. Dates and locations are important in order to identify exposure to war.

12. Additional Patient Data Collection –2017 Proposal Work Information-Industry/Occupation Request Comment on: • Whether we should propose as part of the 2017 Edition that EHR technology be capable of enabling a user to electronically record, change, and access the following data elements for certification: • Narrative text for both current and usual industry and occupation (I/O), with industry and occupation for each position linked and retained in perpetuity and time stamped. • CDC_Censuscodes for both current and usual I/O, with industry and occupation for each position linked and retained in perpetuity and time stamped. • We solicit public comment on the experience EHR technology developers, EPs, EHs, and CAHs have had in capturing, coding, and using I/O data. • The Department of Veterans Affairs and HHS are currently assessing how best to appropriately and efficiently capture I/O information and military service information about patients in EHR technology. We welcome comments and suggestions on any potential options we should consider for our assessment.