1. Implantable Device List
A new requirement this round is recording of implantable devices (315.a.14). Implantable devices include stents and pacemakers. Each of these devices has relevant information about its design and identification, such as brand name, version or model, serial numbers or expiration dates. EHRs will now have to record this information and store it in the patient record and include it in their CCDA summary record exports.
2. Import QRDA files for CQMs (no longer manual entry)
CQM testing (315.c.1-c.4) is never easy, but adding to its challenge is the requirement that an EHR must support automatic import of QRDA patient files and perform quality measure calculation. Though this was an option in 2014 Edition, most vendors elected to skip it and do the manual entry.
3. CCDA Summary error checking
The electronic file of a patient’s record is the CCDA summary record (315.b.1). Besides upgrading to a newest implementation guide for CCDA creation, there will be greater checking of the document syntax compared to the standard and also vocabulary standards, such as for medications.
4. Edge protocol.
In the previous 2014 Edition, a major emphasis was the secure transport exchange called Direct. Though Direct is still a requirement (315.h.1/h.2), EHRs will also need to support the Direct Edge protocol (315.b.1) to connect to a HISP or HIE. Though similar, it is different, and our early testing indicates the Edge test tool is potentially the most complicated tool ever for the ONC program. Developers should start looking at this one early.
5. Patient portals must support email (and not necessarily Direct).
Speaking of Direct, the patient portal criteria (315.e.1) is changed to no longer explicitly require Direct but simply any encrypted method transition (vendors who have implemented Direct can still use it to satisfy the requirement). However, the biggest change is the portal must also support “normal” email transmission. Users found the Direct-only option to be too limiting.
6. ePrescribing expansion and bi-directional exchange.
Though electronic prescribing (315.b.3) is not new, the requirements for certification in 2015 Edition have significantly increased. Previously, an EHR only needed to send a New Prescription message, but now it must include other messages such as Change Prescriptions, Cancel Prescriptions and Refill Prescriptions. Adding to the challenge, EHRs must be able to receive Fill Status Notifications and Medication History Information messages from a pharmacy test tool. The last two messages are from a pharmacy to the EHR, so the exchange is bi-directional. Though some of the messages are common to the industry, others are relatively new and not widely tested
7. Access to patient data through an API
A major point of emphasis with ONC and CMS is opening up access to patient data and encouraging innovation, especially on the mobile side. A new requirement to facilitate that is API functionality. EHRs will need to have open interfaces (315.g.7-g.9) to allow other systems to access patient data. This kind of change requires good design, especially on the area of security.
8. Patient health information capture
EHRs will now need to electronically identify and record patient shared health information and documents (315.e.3), such as advance directives and birth plans. Though this is a relatively easy criterion to test, its biggest challenge is to ensure that usability and workflow design are effective and work both for the providers and patients.
9. More Public Health Choices
ONC and CMS have enabled significantly more choices for public health activities. Besides the standard immunization and syndromic surveillance options, new choices include electronic case reporting and antimicrobial use and resistance (315.f.1-f.7). Not all public health choices must be certified, but vendors should begin early in assessing which ones their customer base will need to submit to CMS for MU measure reporting.
10. Greater specificity with Safety-enhanced design, QMS and Accessibility-centered design
As before, vendors will need to show their systems follows a user-centered design standard (315.g.3), but the usability testing is more detailed than before. Also, the QMS (315.g.4) now requires using a formal QMS standard established by the Federal government or a SDO or at least an explanation of how the existing QMS is mapped to one of these formal standards.
Though these are some of the major changes, there are many more differences and updates. Drummond Group provides resources to help vendors, including detailed criteria overview sheet and video tutorials.
But the best resource we offer is our test proctors. Upon completing sign-up for testing, you are given unlimited access to our test proctors to answer all your questions. We encourage vendors to sign up early, several months before their product is ready to test, to take advantage
First step to sign-up is registering for our testing services on our website: https://www.drummondgroup.com/ehr-home. Or contact us our sales and client engagement team below.
On January 11, CMS Acting Administrator, Andy Slavitt made some remarks about Meaningful Use and its future that have caused some to question how this will impact certification. While his comments may seem shocking at first glance, they are not really introducing anything new. MU will continue, but in a new format to be determined by the CMS, through the use of certified EHR technology. The constant that remains is that certified EHR technology will still be required. The most current and advanced criteria to achieve interoperability, which continues to be desired by CMS and others, are found in the 2015 Edition program. And as Mr. Slavitt and ONC Director Dr. Karen DeSalvo confirmed in a joint statement the following week, the existing regulations of providers moving to Stage 3 and using EHRs certified on the new 2015 Edition certification criteria by January 1, 2018 remains in effect.
On Oct. 6, the Centers for Medicare & Medicaid Services (CMS) released its final rule for modifications to the 2015-2017 incentive program and meaningful use (MU) Stage 3. Simultaneously, the Office of the National Coordinator for Health Information Technology (ONC) released its 2015 Edition Certification Criteria Final Rule.
While awaiting ONC’s 2015 Edition test procedures, Drummond Group is currently preparing for this next phase of testing and certification. In the meantime, we know there are questions related to registration, test schedule and pricing information. We will release these details once plans for testing have been finalized over the next few weeks.
CCHIT recently announced that it will no longer offer ONC testing and certification services, and predictably, we have had numerous inquiries on related matters, such as our future in the ONC program and thoughts on the 2014 Edition criteria. We wanted to issue a single response to address these questions.
First, the process of changing from one ACB to another is well defined under the ONC program and supporting ISO guidelines for certification bodies. There is nothing “new” or “special” about the process. Any EHR software vendor may request its certification(s) be moved to another accredited certification body. Starting point for joining Drummond Group is going to our website and submitting a certification-only registration, or if you are needing testing as well, for example, to go from an EHR Module to a Complete EHR, register for testing.
Second, while the 2014 Edition program is certainly more challenging than the previous criteria, we are very comfortable with the requirements and our ability to support our customers in their pursuit of certification. To date, Drummond Group has tested and certified approximately 60 percent of all 2014 Edition Complete EHRs and nearly 50 percent of all 2014 Edition certified EHRs on the ONC CHPL. We offer WAVE testing options to break out the testing activities over a period of time, tutorial videos on every criteria with other supporting documents, Dry Run testing options and unmatched one-on-one support with our highly trained technical proctors.
And finally, Drummond Group will continue with 2014 Edition Testing and Certification, and we plan on being an ONC-ACB and authorized testing lab for the foreseeable future. We are not in EHR testing for the short term, but rather, the long haul. This was true when we said it in 2010 and it is true now. We are excited about the future of HIT testing and the ONC certification program.
We look forward to working with you in the near future.
If you left for your weekend early on Friday, Dec. 6, 2013, you might have missed a joint announcement issued by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) on their proposal to modify the implementation of Stage 3 meaningful use for the Medicare or Medicaid EHR Incentive Programs and the next set of required ONC certification criteria until 2017. (The entire announcement may be viewed here.)
Please note this is a proposal - and not official policy which must be documented in federal regulation - so nothing is set in stone. However, CMS and ONC do not casually release announcements like this unless there is great confidence in the intended direction, so you should consider the proposed ideas as highly likely.
So what does the proposal say and not say? It DOES state the following:
But, the proposal does NOT state the following:
So what does this mean for EHR vendors? If you have not already certified your EHR to the new 2014 Edition criteria, continue with your plans to achieve certification in 2014. Don’t delay. You may register now for testing and certification on our website. We have terrific support videos and documentation to offer in explaining the requirements of the criteria, and our test proctors provide one-on-one access and terrific support to answer your questions.
If you have already certified your EHR on 2014 Edition, we recommend maintaining focus on supporting your customers with your certified EHR and not worry about any new rulings. To paraphrase Kenny Roger’s “The Gambler,” there will be time enough for studying (and worrying) about the new certification requirements after they are published.
Drummond Group Inc.
With the current shutdown of funding for most federal government programs, many of the services provided by the ONC and its partners in NIST have been affected. However, it does not impact Drummond Group’s ability to conduct testing services or grant certifications as we are in full operation within the established ONC EHR program, including 2011 and 2014 Edition ONC tests and certifications, attestations, new registrations, etc.
It is important to note that an EHR is certified when the ONC-ACB grants certification and this is not conditional on the ONC office being open. Certifications granted by Drummond Group are effective immediately per the rules of the ONC program. Drummond Group also has local copies of the current ONC test tools to enable testing to continue without interruption.
Although we can still issue certifications, the ONC staff is on a furlough status. In addition,
Again, it does not hinder the testing and certification services provided by Drummond Group. We look forward to conducting business as usual and will keep you posted on any developments.
Dear EHR Community,
Drummond Group, recently approved to test and certify 2014 Edition criteria by HHS’ Office of the National Coordinator for Health Information Technology (ONC), is now providing electronic health records (EHR) software developers and vendors a Decision Guide to 2014 Edition that essentially bridges the knowledge gap between the ONC’s 2014 and 2011 Edition criteria. In essence, this new guide will help reduce the complexity of the decision-making process to meet Stage 2 Meaningful Use requirements, potentially leading to more expedient compliance with the 2014 Edition criteria for software vendors and improved readiness for their providers and hospital customers.
The Decision Guide to 2014 Edition includes three components:
Delivered as a “self-help” tool, the Decision Guide to 2014 Edition enables vendors to assess their current software development status as well as their customers’ needs to make the best choices for 2014 Edition criteria selection. The document specifically walks software developers through an EHR category decision tree that helps to determine if they should classify their solution as a complete EHR, or a variety of EHR modular options and describes the testing details.
While the Framework Document helps vendors zero in on important criteria, the Drummond Group Pre-Test Assessment Tool, along with access to the experienced Drummond Group test proctors, will allow vendors to gauge their product testing readiness. Once vendors understand where their product stands with respect to the testing requirements, they can consider the optional Wave Testing Approach which enables better test management by seeking certification for certain requirements in phases. As such, vendors can demonstrate compliance while still working toward comprehensive certification. The approach meshes with typical software development efforts, making it possible for vendors to systematically move toward earning certification. Best of all, vendors can leverage the fact that their products are moving toward full certification in their marketing campaigns.
“With the Wave Testing Approach, we are offering vendors the ability to tackle the job in phases. As such, the whole process is more doable,” Meadors adds. “We know what software vendors are up against and that’s why we are presenting this optional Decision Guide to 2014 Edition that can help vendors easily move from where they are today to where they need to be to offer software solutions that can successfully be used in the government’s EHR adoption program.”
To achieve ONC approval for 2014 Edition testing and certification, Drummond Group was accredited by NIST’s NVLAP (200979-0) for their EHR Test Lab and by ANSI (1045) for their EHR Certification Body.
We appreciate your interest in our programs and look forward to working with you in 2013.
Dear EHR Community,
Drummond Group recently participated in a workshop sponsored by the Office of the National Coordinator for Health Information Technology (ONC-HIT) for ALL of the Authorized Test Labs (ATL) and Authorized Certification Bodies (ACB) to review the 2014 Edition Criteria, test procedures and test tools. The ONC draft test procedures have all been distributed for review, and ONC is in the process of reviewing the comments. On Nov. 13, ONC provided public webinars for review of the proposed test tools. The test procedures and test tools are expected to be finalized in December before the holiday break, hopefully this week.
The workshop was very informative, and we were very impressed with the detailed work that occurred to create the test procedures and test tools. It is clear that the complexity of testing the new 2014 Edition has significantly increased from the 2011 Edition.
Drummond Group continues to field questions about 2014 Edition testing and certification. We appreciate your continued interest in our upcoming program. Here are some key points:
We appreciate your interest in our programs and look forward to working with you in the new year!
Drummond Group Team
You may find the ONC FAQ on this matter in Question 10-12-026-1 found on its FAQ site: http://www.healthit.gov/sites/default/files/pdf/onc-regulations-frequently-asked-questions.pdf
Drummond Group Inc.
Please bookmark this webpage and check back often over the next several months as more test procedures are released.
Drummond Certified™ Seals In the ONC Final Rule for the 2014 Edition Criteria, ONC modified the certification seal text to be issued by certification bodies and displayed by vendors of certified products. It will no longer reference a calendar year; the certification seal text will now reference the specific certification criteria edition. For example, certifications issued after Oct. 4 for the current certification criteria will include the text: "This Complete EHR is 2011 Edition EHR certification criteria compliant..." The Drummond Group certification logo images will also be updated to reflect the new "2011 Edition" reference. However, ONC did clarify that current seals already issued are still valid and do not need to be updated. As ONC has noted, previous certifications remain valid until Dec. 31, 2013.
Changes in the Permanent Program Oct. 4 marked the beginning of the Permanent Program for the ONC HIT Certification Program. For vendors of EHR technology, there are two key changes which do impact the testing and certification of a product.
1) Test reports will now be publicly viewable. The test reports describe the results, such as the modules a product successfully passed. However, they will NOT indicate any modules which failed.
2) Marketing new products’ certifications must include language regarding price transparency. These are any additional types of costs that an EP, EH or CAH would pay to implement a complete EHR’s or EHR module’s capabilities in order to attempt to meet meaningful use objectives and measures. EHR technology self-developers are excluded from this requirement. These are the types of additional costs, but the actual dollar amounts will not have to be listed.
For example: An EHR technology is certified to the 304.g Timely Access certification criterion. However, EP must pay an “ongoing” monthly service fee to the EHR technology developer for it to host/administer this capability in order for the EP to meet the correlated MU objective and measure, the existence of this potential “ongoing” cost would need to be disclosed by the EHR technology developer. Therefore, an example of the price transparency language which must be included whenever the vendor markets its ONC certification status could be “This certified product-version may require ongoing monthly costs to support online patient service (170.304.g).”
This affects certifications issued to products for any certification request received ON OR AFTER Oct. 4. This is not required for previously issued certifications in the Temporary Program although we encourage vendors to begin including this language.
Again, Drummond Group plans to continue delivering updates on related critical information as it is released by the ONC. In the meantime, we appreciate your questions and look forward to continuing a relationship that will carry your product(s) successfully to the next phase.