Responses to Requests for Comments Embedded in the ONC NPRM 04_2012 AMIA 4720 Montgomery Lane, Suite 500 Bethesda, MD

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1 Requests for Comments Embedded in the ONC NPRM Imaging- imaging results and information are accessible (a)(12) We request public comment regarding whether there are appropriate and necessary standards and implementation specifications for this certification. Family Health History- record as structured data (a)(13) We seek comments on the maturity and breadth of industry adoption of the HL7 Pedigree Standard format for export and import of family health history and the use of SNOMED-CT terms for familial conditions and their inclusion, where appropriate, on a patient s problem list. We also note that the Surgeon General has produced a tool that can capture, save, and mange family health histories using standard vocabularies and can export the data in extensible Markup Language (XML) format. We seek comments on the maturity and breadth of adoption of this tool and its export format. AMIA Member Comments DICOM is the standard used by the medical imaging community and is required for diagnostic quality images. DICOM embraces other common image formats that are also medically useful such as JPEG but that is not generally recognized. Around 2005 the Comprehensive Healthcare Informatics (CHI) initiative for the Federal government struggled for close to two years trying to close on a standard. Today, as then, closure is difficult and we believe that the criteria should be silent as to specific standards but provide suggestions for common ones and perhaps a short description of when use of that standard is appropriate. We believe that few know of either the Surgeon General s tool or the HL7 Pedigree Standard. As the tools are inter-related an indication of usage rate could be found from the Surgeon General s office. We believe that few have records using either tool and common knowledge is weak. Review of the Surgeon General s tool indicates Family History uses broad terms for a disease such as a layperson would use. Consensus is needed to determine if this suffices a level of detail. If it is, then ICD-9/10-CM is more useful than SNOMED, which has little penetration, in expression the terms as it is used by essentially all healthcare providers today. Note that both the HL7 and Surgeon General s tools are designed for uploading into an EHR. The standard is silent on that use. Both use XML to prepare the transfer and this is the now common exchange format widely used outside of healthcare. No concerns are raised by the use here. Many, both inside and outside healthcare, are trained to use XML. The standard data elements to be considered for this were contributed during HITSP work. They were accepted as a standard set for family health history then. The vocabularies exist, but certainly have not been adopted except in research practices and perhaps in some hospitals. We recommend all problem lists and family history data elements to be reviewed and updated to accommodate SNOMED. We also recommend patients having access and being involved in developing their own family health pedigree. There needs to be a transition plan and time period and education for the clinical users. 1

2 Amendments-Protect electronic health information created or maintained by the CEHRT through the implantation of appropriate technical capabilities (d)(4) We specifically request comment on whether EHR technology should be required to be capable of appealing patient supplied information in both free text and scanned format or only one or these methods to be certified to this proposed certification criteria. View, Download, and Transmit to 3 rd Party- provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP For EHs and CAHs- provide patients the ability to view online, download and transmit information about a hospital admission (e)(1) For example, we welcome comment on, and will consider moving from, the use of object identifiers (OIDs) to uniform resource identifiers (URIs). No significant comment on the proposed standard. The ability for a patient to add comments to a record is required by HIPAA, as noted, and the EHR needs to ability to allow it. Taking the small step noted in this standard is significant move forward in making the EHR more patient-accessible. Proposed is an extremely complex standard embracing a number of transport, format, terminology and viewing requirements. The standard is presented without any indication of industry readiness regarding use of the standards or, if not widely used, site introduction implications such as infrastructure improvements regarding the internet or training. These should be described and added to fiscal impact statement to help illustrate the true cost of this proposed rule. The standard only applies to the uploading of information and does not discuss the downloading and use of the information by a user. One issue not mentioned is identity matching in the registry standards they propose using. Identity matching is a problem with Hispanic and more so with Asian names. Failure to associate the data with the correct patient could create more quality problems then the standard hopes to resolve. The standard requires the use of CDA for this purpose terminating years of study with the alternative, and Stage 1, standards of CCR and CCD. No justification is presented for this change other than observational in the ability to present computable content. As the standard is unclear as to end use it is unclear why the more widely used CCR was discarded. Providers clearly prefer text to computable formats. Until there is either a requirement regarding how the end user treats the received information or a justification based on actual user preference toward CDA this standard should be silent on format. We believe that the proposed move to URI from OIDs is positive. Most of the proposed standards have had some level of penetration in US Healthcare but electronic exchange is not widely done and hence little experience exists. ONC 2

3 needs to consider more fully the cost/benefits of a widespread introduction of information exchange that this standard envisions. We strongly suggest that pilot studies using emerging HIEs be performed using the standards proposed before universal implementation. Finally, consideration needs to given toward the fiscal viability of HIEs if mediated exchange, versus point-to-point, becomes widespread. While standards based health information exchange is a centerpiece of ONC s charter since the founding, the industry is still short on experience for universal introduction. Safety-enhanced design (g)(4) Quality Systems We request public comment on this additional certification criterion and the feasibility of requiring EHR technology developers to document their current processes. We recommend the final rule name RxNorm Concept Unique Identifiers (RXCUI) for the interoperable exchange of medication allergens. This recommendation is consistent with HIT Standards Committee hearing comments of March 27th. Use of the RXCUI removes the complexity of representing the VA NDF-RT code for classes (for example, RXCUI 7986 for Pencillins [NDF-RT Code = N ]), NLM RxNorm Code for medications, (for example, RXCUI 723 for Amoxicillin [RxNorm Code 723 ])and the FDA UNII code for substances (for example, RXCUI for fd&c yellow no.5 [FDA UNII Code I753WB2F1M ]. Note that RxNorm for medications as causative agents is included within the NPRM via reference to the National Quality Forum (NQF) Quality Data Model, Version 2011 (Clinical quality measure data capture and export). AMIA is supportive of the use of user centered design (UCD) methodology as a first significant step to improving overall usability of Health information technology. We believe that it is reasonable to begin to ask EHR technology developers to document their current processes. Clinicians and providers need software and user interfaces that work with clinical workflow. All clinicians need systems that are usable and friendly and that support care delivery. Ease of EHR technology use is critical to adoption and patient safety. However, while the goals of this criterion are well intentioned the criterion may add a large testing and record keeping burden on EHR developers and manufactures. Some of AMIA s member s believe that if implemented this standard may be burdensome. AMIA notes that the FDA uses the ISO Quality standards and that the NIST has developed extensive resources on usability. Opinions differ regarding the extent to which usability can be governed but this topic is certainly an important issue. 3

4 We support the concept of system design being aware of safety. We believe that this item requires a more specific definition prior to implementation. We support the informed development of standardized formats and processes for identifying and reconciling errors related to medical/surgical devices, supplies, and electronic health records. Patient Safety Events We request public comment on whether we should adopt such a certification criterion and what, if any, challenges EHR technology developers would encounter in implementing this capability. AMIA supports current efforts to facilitate patient safety data collection and event reporting, and we applaud efforts for conceptualizing a framework to track potential patient safety issues related to HIT use. However, as AMIA has suggested in prior comments to NQF/AHRQ we urge that any framework be further developed and enhanced to better clarify the types of events to be reported, when and by whom, provide unambiguous and concise definitions of terms, and expand reporting to allow inclusion of device interoperability and device/hit functionality. We support the intent of this criterion. However, how it is specifically defined and applied needs to be carefully considered. The definition of the criterion needs to encourage user centered design and patient safety considerations but not impede development or overload the development/documentation process with unnecessary minutia. Problem List- Maintain and up-to-date problem list of current and active diagnosis (a)(5) We welcome comments on our interpretation of longitudinal care. We also welcome comments on whether a term other than longitudinal care could and should be used to express the capability required by this certification criterion and the other referenced certification criterion ( medication list and medication allergy list ). We believe that establishing a fixed format and embedding in the EHR is a good idea. It should be possible to enable an EHR to produce the type of desired report but we believe that this will require a lead-time after rule adoption of 2-3 years. 1. The proposed standard for longitudinal care is inadequate. Having said that CMS is quite correct in observing alternative definitions do not have a consensus and the practical one presented is as good a solution as any other. The ideal definition would be one involving a longitudinal record associated with an episode of care, regardless of location and timeframe, but defining an episode of care to a computer is difficult. 2. The standard is centered on the use of SNOMED-CT and accepts no other alternative. While SNOMED-CT is freely available in the US and has been since the middle of the last decade, it is poorly used. Few are trained in it and little testing has been done using CDS, a vision feature of this standard. Given this situation, the proposed Standard should proved real extent on the use of SNOMED-CT for day-to-day 4

5 clinical support in the US. Given the US governments committed payment of about $5M/year to the licensee of SNOMED for free internal distribution use of SNOMED-CT in this standard most likely could not be banned. Like the Stage 1 standard the widely used administrative code (ICD-9/10-CM) should also be allowed for Problem Lists. Ideally, the NLM should abandon continuing payment for SNOMED-CT, which allows continuing use in the US forever of the last version, and free the $5M/year for research. All future extensions in SNOMED_CT useful to the US will most likely occur in the newly formed US Extension, making the Core less needed. While ICD-9-CM lacks the clinical precision needed for good CDS support, it was recently shown the ICD-10-CM (1/2011 version) provides exact coverage for about 70% of terms found by the NLM on Problem Lists and adequate coverage for up to 95% (S.J. Steindel. A Comparison between a SNOMED-CT Problem List and ICD-10 HIPAA Code Sets. Perspectives in Health Information Management, (2012)). The article further notes that if attention is paid to the use of ICD-10-CM for Problem Lists the coverage could be easily optimized. We note that the terminology for CQM is not currently set by CMS and could be adjusted to successfully use ICD-10-CM as well and still meet the requirements of CQM. We note that most current quality reporting uses the less detailed ICD-9-CM. The Standard notes that no difficulties should result in the use of SNOMED-CT for clinical Problem Lists and the use of ICD-10-CM for Administrative versions. It is noted that that this is the equivalent of keeping two sets of fiscal books: one for the IRS and another you internal use. As in the fiscal world this can results in inconsistencies difficult to explain. Finally, few in the US are trained to US SNOMED-CT. The Standard would require site support on the correct use of SNOMED-CT and fiscal analysis should consider these costs. As a first approximation they are equivalent to estimated cost of introducing ICD- 10-CM (the implementation costs are perhaps included in the present estimated but 5

6 the training costs are not). We believe that the training costs for SNOMED-CT would exceed ICD-10-CM as the basics of ICD were known to vast number of users. That is not true for SNOMED-CT. Clinical Decision Support- use clinical decision support to improve performance on high-priority health conditions (a)(8) We request comment on industry readiness to adopt this standard and on the benefits it could provide if required as a part of this certification criterion. The definition of longitudinal care as provided in the NPRM is too limited. The definition provided would be more suitable to encounter of care or episode of care. The term longitudinal should be reserved for referring to care provided across care settings and across episodes or encounters of care. The definition as provided does not imply or include traditional longitudinal care settings of nursing homes, home health, hospice, assisted living, group homes and the cross overs of exchange of those entities. We strongly recommend not using the term longitudinal care with the definition as provided. Doing so will lead to confusion and miscommunication. We take strong issue with the proposed requirement that CDS interventions be triggered when new information is incorporated into the EHR technology as a result of a care transition. Generating an alert, reminder, or other CDS intervention when data first arrives into CEHRT is a valid tactic to ensuring the incoming data is combined with local information about the patient which is reasoned against a set of criteria. However, an equally valid tactic would be for CDS interventions to be triggered when a clinical user logs into the system or selects a specific patient record for review. We believe that the choice of tactic (e.g., whether to generate the alert when the information arrives at 3:00am from the other system or generate the alert at 8:10am when the physician chooses to review the transferred patient s record) should be left up to the CEHRT implementer. There are potential performance and/or practical reasons why a local implementer of CEHRT may not wish to adjudicate CDS rules when data first arrives into the system. There may also be considerations based on a particular vendors proprietary model for data design or CDS interfaces that may dictate an equally valid alternative to the one proposed by ONC. We ask that ONC be mindful of this when finalizing the rule that encourages CEHRT to act on incoming data during care transitions. The standard is well developed and offers a lot of flexibility in the rules and terminologies used. We believe that underlying standards are not in widespread use and the few impact of this standard will take years to realize. Nevertheless, it should be implemented as optional to allow testing and development. 6

7 We believe that substituting the term intervention for rule is a positive step and reflects the diversity of CDS solutions available now in the marketplace and in development for future deployment. We also believe it is important for EHR technology to import or update value sets for the expression of CDS vocabulary. Without value sets, the definition of diseases and conditions could be interpreted differently by different facilities, making comparison of outcomes and results problematic. Value sets also ease the informatics implementation efforts for a facility. Transitions of Care The EP, EH, or CAH who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary of care record for each transition of care or referral (b)(1) Incorporate summary of care record (b)(2) Create and Transmit summary care record We request public comment on whether in the final rule we should create separate certification criteria for all of these data elements. We believe that the industry is not ready to adopt (i) Evidence based decision support interventions as described in this criterion. The ability to meet (ii) Linked referential clinical decision support is more obtainable. We believe the industry would have mixed ability to meet (iii) Configure clinical decision support. We believe the industry would have mixed ability to meet (iv) Automatically and electronically interact. We believe would have difficulty meeting (v) Source attributes. The greater concern with this criterion is the ability for the industry to keep the content updated and current. Comments made above regarding (e)(1) apply to this proposed standard as well. As noted above, the issue of patient matching is a large problem and the success of either standard is very dependent on how successful that is. As noted above, we do not believe that implementers are well prepared to use the same format and terminology standards as required here. We believe that insisting on a nationwide, rigid set of standards will vastly delay widespread use. If widespread use is the end goal with true understanding by the receiver it is better to have the receiver do the adjudication. Experience within Public Health, which tried and is still trying, to implement standards conformity is an example of the failure of this method. The Indiana Health Information Exchange is an example the success you can achieve if the receiver does the adjudication. Instead of trying to implement this standard it would be better for the Government to invest in better Computer Science techniques to adjudicate despite data automatically. Based on these comments, the idea for certification of independent vocabulary elements would not be a productive effort. We support the data elements listed for inclusion in the summary of care record to be standardized for interoperability purposes. Creating separate certification criteria for 7

8 all of the data elements may lead to a prioritization in the data elements with some being more important than others. The impact and purpose of creating the separate certification criteria should be carefully considered. Phased approach towards a separate certification criteria for all of the data elements may be needed. We welcome comments on whether equivalent alternative transport standards exist to the ones we propose to exclusively permit for certification. We also welcome comment on our proposed approaches for deciding whether additional transport standards are appropriate and for adopting any such standards through interim final rulemaking with comment. Additionally, in the context of the proposed limitations included as part of the proposed MU Stage 2 measure associate with this objective (which is percentage-based), we request public comment on any difficulties EHR technology developers might face in determining the numerator and denominator values to demonstrate compliance with the automated numerator calculation or automated measure calculation certification criteria we propose to adopt. Recommend the final rule name RxNorm Concept Unique Identifiers (RXCUI) for the interoperable exchange of medication allergens. This recommendation is consistent with HIT Standards Committee hearing comments of March 27th. Use of the RXCUI removes the complexity of representing the VA NDF-RT code for classes (for example, RXCUI 7986 for Pencillins [NDF-RT Code = N ]), NLM RxNorm Code for medications, (for example, RXCUI 723 for Amoxicillin [RxNorm Code 723 ])and the FDA UNII code for substances (for example, RXCUI for fd&c yellow no.5 [FDA UNII Code I753WB2F1M ]. Note that RxNorm for medications as causative agents is included within the NPRM via reference to the National Quality Forum (NQF) Quality Data Model, Version 2011 (Clinical quality measure data capture and export). Internet based transport standards, especially in a Web Services environment constantly change. Encapsulating transport standards in regulation will prevent timely movement toward newer techniques. Transport standard should be addressed by ONC through a list of approved methods and a mechanism to modify the list overtime, which is moving the actual methods to Guidelines. We believe that additional detail is needed. The proposed transport standard selection is lacking detail. The proposed standard is silent on what would determine numerator or denominator data and is difficult in commenting if an EHR can easily determine either. Writing counting rules to a vague standard is impossible. Writing counting rules to specific criteria should be within the scope of any EHR vendor, though the validity of these numbers may lack meaning if the goals not well defined. 8

9 Clinical Information Reconciliation- The EP, EH, or CAH who receives a patient from another setting of care or believe and encounter is relevant should perform medication reconciliation (b)(4) Finally, we request public comment on whether as part of this certification criterion we should require EHR technology to perform some type of demographic matching or verification between the data sources used. This would help prevent two different patients clinical information from being reconciled. We propose to adopt this revised criteria. Incorporate laboratory tests and values/results- Incorporate clinical laboratory test results into Certified EHR technology as structured data (b)(5) We request public comment on whether the proposed standards for the ambulatory setting should also apply for the inpatient setting and whether the LRI specification (even though it was developed for an ambulatory setting) is generalizable to an inpatient setting and could be adopted for certification for that setting as well. As noted, successful implementation of clinical data from desperate sources will have benefit in the EHR world. We believe that that most providers successfully do Clinical Reconciliation today using paper so the actual improvement may be difficult to measure. It is still a worthwhile goal. From a certification view the standards really requires three steps by the EHR Vendor. The first is the hardest and that is to do patient matching with a registry if required. The level of success on this step is dependent on the patient population, the correctness of the demographic in the registry or submitted, and the depth the information used for the match. The EHR has no control over any of these steps. The role it has is just to apply the algorithm selected and present to the user, in the second step, the selected patient or an interface for human adjudication of multiple patients, some of whom maybe the same. The last step is the display of the clinical information to reconcile with information, such as source, that will allow an informed selection. The last two steps are user interface issues that can only be described and not proscribed..we encourage the criterion to include all medication types such as respiratory treatments. We also acknowledge this criterion is limited by only including EP, EH and CAH. The need for this functionality is needed across all care settings. No significant comment on this standard. As noted, it worked well in Stage 1 and should going forward. We believe that the HL7 standard and implementation guide are good choices. 9

10 Clinical Quality Measures (c)(1) Clinical Quality Measures- Capture and Export (c)(2) Clinical Quality Measures- Incorporate and calculate (c)(3) Clinical Quality Measures- Reporting Alternative Data Capture Certification Options Considered We recognize that the gap between the data defined by the QDM and the data traditionally captured in EHR technology is, in some areas, broad and we request comments regarding (1) Industry readiness for the expansion of EHR technology data capture; (2) how this would impact system quality, usability, safety, and workflow; and (3) how long the industry believes it would take to close this gap. Additionally, we recognize that some specialty-focused EHR technologies may not need to capture all of the data that the QDM describes. We request public comment regarding how certification can accommodate specialty EHR technology developers so that they would not have to take on development work (solely to get certified) for functionality that their customers may not require. CQM-by-CQM Data Capture We request public comment on whether we should take this approach instead of our proposal on certification for data capture. Explicit Certification Criteria We request public comment on whether this approach would be preferred, which certification criteria should be expanded, and where new certification criteria would be appropriate. We believe this approach could also ensure when EHR Modules are used in combination to meet the definition of CEHRT that all of the data necessary to capture for CQM calculations would be electronically available. We support the intent of this criterion but believe the industry is not ready to adopt it. The criterion could have a positive impact on patient care quality and safety. We support addressing this through a phased approach that encourages the use of standardized terminology for clinical quality measures. We are unable to comment on the time and activities required to close the gap to readiness for adoption. We believe that this standard is quite premature. At the end of last year CMS convened the first Technical Review groups to suggest which CQMs are best adaptable to the EHR. The initial set of candidate measures is quite limited and only a small number will be selected for testing. It was also observed, as noted in the proposed Rule, that many of CQMs are not phrased appropriately for use in an EHR. It appears that making these important measures computable will involve an iterative cycle over several years. Methods should not be cast in stone by regulation during the development phase. We believe that for initial testing the proposed standards offer enough options to make for robust study and eventual implementation. We believe specialty-focused EHR technologies need to be able to transmit the data they collect that is relevant to QDM. We support all systems collecting what is relevant care to their care area and transmit it to the larger reporting area. We request that this statement be explained in greater detail. As currently worded it s difficult to understand. While many of the data elements for a CQM will not come from patient visits recorded in an EHR, if the EHR is the reporting source for CQM they must be prepared to get the needed data. Hence, vendors will need to develop certifiable methods to acquire the data, or abandon the reporting of a CQM from the EHR. See comment above about this being premature to encapsulate in a regulation. 10

11 Constrain the QDM We seek public comment, especially from measure stewards, as to the difficulty and timeliness with which CQMs could be re-specified in accordance with the constrained QDM style guide. Data Export We request comment on whether any standards (e.g., QRDA category 1 or 2, or Consolidated CDA) would be adequate for CQM data export as well as whether Complete EHRs (that by definition would include calculation and reporting capabilities) should be required to be capable of data export. Clinical Summaries- Provide clinical summaries for patients for each office visit (e)(2) We welcome public comment on whether we should adopt separate certification criteria for these data elements. For certain other data elements in (e)(2), we propose to require that the capability to provide the information be demonstrated in accordance with the specified vocabulary standard. Integrity- Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities (d)(8) Thus, we request public comment on whether we should leave the standard as it currently reads or replace SHA 1 with SHA 2. See comment above about this being premature to encapsulate in a regulation. See comment above about this being premature to encapsulate in a regulation. When the EHR is ready for reporting CQM data is to time to discuss Data Export standards. Now is not the time. We note that this is approximately the third manifestation of this standard. The objection to data level standards was noted above. Having essentially the same criterion presented in various standards will likely lead to confusion for vendors and testers and should be avoided. We recommend that they be consolidated in the Final Rule. In principle, we support the intent of this criterion, but recognize the need to include the entire continuum of patient care, not just the ambulatory care setting. We support the use of specified vocabulary standards. Creating separate certification criteria for all of the data elements may lead to a prioritization in the data elements with some being more important than others. The impact and purpose of creating the separate certification criteria should be carefully considered. Phased approach towards a separate certification criteria for all of the data elements may be needed. If the intent of this standard is to digitally sign all information in an EHR then it should be SHA-2, regardless of present state. We are concerned that digitally signing EHR entries opens a tremendous number of useful techniques regarding deliberately altered data, by the patient or provider. 11

12 Redefining Certified EHR Technology and Related Terms We request public comment on alternative approaches we should consider that would provide equivalent simplicity and flexibility for EPs, EHs, and CAHs, as well as EHR technology developers, but that would still meet our programmatic goals and timelines. (pg ) Specific comments on alternatives approaches to certifying EHRs should come from vendors and end-users and not the general public. We believe that offering vendors and end-users the greatest flexibility in regulatory requirements is preferred. Base EHR Accordingly, we are interested in comments on whether we should require certification to a set number of CQMs as part of certification to (c)(2). For example, we could require EHR technology designed for the ambulatory setting and that would constitute an EP s Base EHR to be able to incorporate data elements and calculate a specific number of CQMs for each of the CQM domains proposed by CMS for EPs in the Stage 2 proposed rule. (pg ) We also request comment on whether a Base EHR should include, in addition to (c)(1) and (2), the CQM reporting certification criteria proposed at (c)(3), which would enable a user to electronically create a data file for transmission of clinical quality measurement results to CMS. (pg ) We are, however, interested in public comment on whether there should be a distinction between the ambulatory and inpatient settings for the certification of EHR technology to the privacy and security certification criteria, including for which certification criteria there could be a distinction and the basis for that distinction. (pg. 13 Adaptations and Certified Complete EHRs or Certified EHR Models We invite comment on our proposed adaptation policy and whether it strikes an appropriate balance between permitting innovation and providing certainty that the EHR technology used by an EP, EH, or CAH has satisfied the certification criteria adopted by the Secretary. (pg ) IV. Provisions of the Proposed Rule Affecting the Permanent Certification Program for HIT ( ONC HIT Certification Program ) 12 This is a laudable goal. The timing however may be difficult (certain components may take longer than others that would affect the numerator or denominator.). As noted above, CMS is not prepared to offer a great number of CQMs to EHR for automation and will not be able to for a number of years. Therefore, the present regulation should be silent in this area. As noted above, CMS is not prepared to offer a great number of CQMs to EHR for automation and will not be able too for a number of years. Therefore, the present regulation should be silent in this area. This is a target we support, but the timing may be unrealistic. We propose that this be encouraged and phased- in over a longer timeframe. We support requiring similar privacy and security certification criteria for both inpatient and ambulatory EHR technology. There should not be more leniencies in one area than the other. The ability to secure and keep private patient information must be site independent. Since HIPAA allows some site related differences is setting security standards the EHR should allow a range of expression. All sites should be able to express their needed methods within a selected EHR. As noted, the need to extend certification to new devices, such as mobile or similar extensions of system features, is needed. The methods discussed here appear satisfactory. The comments made concerning extension of security and privacy are well needed as present uses of these devices may compromise those features and need strengthening No significant comment on the proposal. We believe that the Temporary/Permanent distinctions were confusing though required as certification evolved. Rapidly collapsing

13 E. Continuation and Representation of Certified Status 2011 or 2014 Edition EHR Certification Criteria Compliant We request public comment on our approach and any other approach that would present the least burden for EHR technology developers and the least confusion for the market. (pg ) Base EHR Representation We welcome comments on these and any other approaches that we have not identified. (pg ) V. Request for Additional Comments Certification and Certification Criteria for Other Health Care Settings As we continue to adopt new and revised certification criteria to support MU, we believe that it is prudent to seek public comment on whether we should focus our efforts on the certification of the HIT used by health care providers that are ineligible to receive incentives under the EHR Incentive Programs. In particular, we are interested in commenters thoughts on whether we should consider adopting certification criteria for other health care settings, such as the long-term care, post-acute care, and mental and behavioral health settings. For those commenters that believe we should consider certification criteria for other health care settings, we respectfully request that their comments specify the certification criteria that would be appropriate as well as the benefits they believe a regulatory approach would provide. Last, we ask that the public consider whether the private sector could alternatively address any perceived need or demand for such certification to one nomenclature is desirable. We believe that that ONC needs to take on the burden, at the request of the vendor, that a Complete EHR or a collection of noted modules meets the requirement of a Base EHR. Allowing the vendor the ability to do that can potentially be troublesome and misleading to the purchaser. AMIA supports the goals of quality patient care and the comprehensive approach to care provided. It seems reasonable to extend the certification criteria to other care settings in general, but the practicality of it without incentives will be difficult. For an electronic healthcare system to function successfully in this country all systems, regardless of care location, require certification. Extension to all areas is desirable. We recommend that Public Health be added to the set noted. The legislation authorizing ONC extends to all of healthcare and all federal system. Public Health is part of that and has done a poor job of policing itself successfully. Alternative health care settings have the same needs and requirements for delivery of good healthcare electronically as the present settings. The major difference in the alternative areas is emphasis on areas and in the terminologies used. Hence, the items requiring certification are the same but the list required a base system may differ. 1. Privacy and security of patient data is paramount to all care settings. 2. Clinical quality Measures. 3. Instantiation of standards 4. Exchange of data supporting Demographic, lab, medication, clinical summary note (summary note data) Certification was in the hands of the private sector before ONC. The HITECH Act forced the government to assume that role and it should continue to all areas. That is not to say the private sector can t do the work. It did and it can. We believe that the legal mandate exists and must be used. As with the present system, the actual certification 13

14 2014 Edition EHR Accounting of Disclosures Certification Criterion We are proposing to adopt this same certification criterion as an optional certification criterion for the 2014 Edition EHR certification criteria ( (d)(9)), but are requesting public comment on whether we should adopt a revised certification criterion. We are interested in whether commenters believe that the 2014 Edition EHR certification criterion for accounting of disclosures should be revised to be a mandatory certification criterion. We are also interested in whether commenters think that the 2014 Edition EHR certification criterion should be revised to include capabilities that would more fully support an EP s, EH s, and CAH s ability to comply with the current HIPAA Privacy Rule accounting for disclosure requirements at 45 CFR Additionally, we are interested in receiving input on whether, and what additional, changes to the certification criterion would be needed to support compliance with the proposed HIPAA Privacy Rule accounting for disclosure provisions, if they were to be adopted by final rule in substantially the same form as they were proposed. [Editorial Note: ONC seems to be endorsing the AOD proposed rule, which included an Access Report requirement- the Access Report was almost universally opposed in the more than 400 responses that HHS received regarding the NPRM) For those commenters that believe revisions are appropriate, we 14 work can be done by the private sector. The checks and balances provided by the private/public partnership is necessary The certification criterion in this area seems appropriate but we believe that this should remain optional. No. HIPAA requires the accounting for disclosures and, as noted, recent regulations have described the process. Accounting for disclosures was noted as a major issue for providers when it first appeared. For several years disclosures to Public Health were stymied because of this issue, as both the reporting and disclosure were required. Providers have developed ways to track disclosures. The EHR vendor should decide if that feature is required by their marketplace and not have it forced on them as a required feature by ONC.. Specifically, we do not believe that the certification element related to the HIPAA Accounting Rule should be changed from optional to mandatory or that any other changes should be made to the certification criterion. We believe that the access report proposed in the Accounting of Disclosures NPRM is unworkable and unnecessary, as we discussed in comments to that rule. No. HIPAA requires the accounting for disclosures and, as noted, recent regulations have described the process. Accounting for disclosures was noted as a major issue for providers when it first appeared. For several years disclosures to Public Health were stymied because of this issue, as both the reporting and disclosure were required. Providers have developed ways to track disclosures. The EHR vendor should decide if that feature is required by their marketplace and not have it forced on them as a required feature by ONC. See comment immediately above. We do not support the proposed move to extend certification of an EHR to HIPAA Privacy requirements, including disclosure reporting,. See comment immediately above. The move to extend certification of an EHR to HIPAA

15 respectfully request that their comments identify whether the certification criterion should be changed from optional to mandatory and identify the specific capabilities that the certification criterion should include and rationale for including those capabilities. Disability Status We are specifically requesting comment on whether there exists a standard(s) that would be appropriate for recording disability status in EHR technology. We welcome comments on whether these standards or any other standards would be appropriate for recording disability status in EHR technology. We ask that commenters consider whether the recording of disability status should be a required or optional capability that EHR technology would include for certification to the 2014 Edition EHR certification criteria. Privacy requirements, including disclosure reporting, is not supported as mandatory. Disability status is extremely difficult to characterize with specific terminology. AMIA notes that the present SSA CCD requires the use of SNOMED-CT to report status. At the time of development SNOMED-CT was the only accepted code set widely available in the US for this purpose. WHO has a Function Status Classification (ICD-F) that is not used in the US and would introduce complexities. As commented above, we believe that ICD-10-CM/PCS will soon be more readily available to all providers with more trained personnel than SNOMED-CT. Assigning a mandatory code set for disability status at this time is premature. Disability status is not required for all patients and where needed will occur in areas of patient information such as a Problem List or Discharge Summary. Also, the information is not needed by all specialties. Certification standards should be silent regarding disability status or be included at an optional level. We also ask commenters to consider whether the recording of disability status should be part of a Base EHR and included in a separate certification criterion or possibly the demographics certification criterion ( (a)(3)). Last, we ask commenters to consider whether disability status recorded according to the standard should also be included in other certification criteria such as transitions of care incorporate summary care record ( (b)(1)), transitions of care create and transmit summary care record ( (b)(2)), view, download and transmit to 3 rd party ( (e)(1)), and clinical summaries ( (e)(2)). Data Portability We seek responses to the following questions: Is EHR technology capable of electronically providing a sufficient amount of a patient s health history using summary of care records formatted according to the Consolidated CDA for the scenario described above? 15 Disability status recording should be optional. It is not necessary to comment none on those who are not affected by a disability. See above. Disability is not required in a Base EHR. Disability status should be included with transitions of care incorporate summary care record ( (b)(1)), transitions of care create and transmit summary care record ( (b)(2)), and clinical summaries ( (e)(2)). See above. Disability Status is not required for all patients or all specialties and should not be required in any reports. When needed, it will be sent as part of existing information We believe that typically providers are not converting their legacy paper records or may be converting a limited amount, to the EHR. This practice may illustrate limited provider need for old data. From this observation we propose that in transferring information to a new system the summary of care records may be sufficient in most

16 Is all of the data in a provider s EHR #1 necessary to migrate over to EHR #2 in the event the provider wants to switch? We recognize that medical record retention laws affect the provider s overall approach in terms of a full archived data set, but our question seeks to determine whether the loss of some data would be tolerable and if so, which data? Considering the standards we have adopted and propose for adoption in this rule, we request comment on what additional standards and guidance would be necessary to meet these market needs for data portability, including the portability of administrative data such as Medicare and Medicaid eligibility and claims. Additionally, we are interested in commenters thoughts related to an incremental approach where a specific set of patient data could be used as a foundation to improve data portability for the situation described above as well as other situations. Does the concept of a capability to batch export a single patient s records (or a provider s entire patient population) pose unintended consequences from a security perspective? What factors should be considered to mitigate any potential abuse of this capability, if it existed? cases. For patients whose episodes of care, such as in cancer treatment, extend over long periods of time more detail will be required. As noted above, for most providers and patients migration of all data is not needed. Data lost would be at a granular, visit oriented level and summary data is that is needed moves forward. Tolerable data loss is very specific to care settings and patient s medical status and medical history. The question has a presumption that providers will use the EHR for all aspects of a practice. For the near and perhaps long-term future this is not the case and ONC should not consider burdening the EHR with Administrative requirements. As noted in several places above, standards should allow for flexibility to prevent loss of fidelity in translating clinical information. Loss of fidelity can easily occur when a vendor uses an internal terminology that the user optimizes for their needs and then has translation tables to produce the information in a myriad of alternative systems. Privacy and security needs to be a focus for the Medicare/Medicaid eligibility and claims. Purchasers of EHRs should be the deciders on the nature of the transfer information (content and form) and not the ONC. As noted above that information can have patient, practice, and specialty implications that can t be factored in advance or by regulation. The incremental approach is supported. Production of migration information should be a special option and perhaps a special program as it should occur in a batch mode for production and import efficiency. We note that at a individual patient level the reports envisioned already exist in the EHR. So the question of abuse at the individual patient level is mute. As noted, the batch level report has large security and privacy issues if it can be easily produced and that must be avoided. There is always potential for abuse and it increases with the larger amount of data or gain available at one time. We are unable to comment on specific mitigation capabilities. 16

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