Top 10 Biggest Changes in 2015 Edition

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.

Lenny Swinson – Director of Sales (This email address is being protected from spambots. You need JavaScript enabled to view it. / 512-826-2938)

Tracy LaRue – Client Engagement Manager (This email address is being protected from spambots. You need JavaScript enabled to view it. / 512-826-2938)

General Inquiries: This email address is being protected from spambots. You need JavaScript enabled to view it.

Meaningful Use is Definitely NOT Over

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.

Read more: Meaningful Use is Definitely NOT Over

CMS, ONC Release 2015 Edition Certification's Final Rules

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.

Read more: CMS, ONC Release 2015 Edition Certification's Final Rules

Drummond Group remains committed to ONC's MU EHR testing and certification services

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.

If you have specific questions on the process, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it..

We look forward to working with you in the near future.

Thank you,

Drummond Group

CMS & ONC discuss new proposed MU EHR timeline in blog

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:

  • Under this proposal, the next set of required certification criteria will be the 2017 Edition which will support Stage 3 beginning in 2017. Thus, EPs/EHs will be using 2014 Edition certified EHRs through 2014, 2015 and 2016 before needing to upgrade by FY/CY 2017. This effectively extends the time of Stage 2 up to three years. This would be the same timeline and approach done in Stage 1 which was initially just FY/CY 2011 and 2012, but CMS and ONC then extended it one more year into 2013 to allow time to release the current Stage 2/2014 Edition rule.
  • The CMS and ONC will be releasing their proposals in more official capacity via a Notice for Proposed Rule Making (NPRM) in Fall 2014 with the Final Rules expected to be released during “first half of 2015.” This is approximately the same process and timeline they used for Stage 2/2014 Edition when the organizations released their NPRMs in February 2012 and later finalized both rules as Final Rules in September 2012.
  • This adjustment of timelines is to primarily collect more information and feedback on Stage 2 adoption and progress so that Stage 3 measures/2017 Edition criteria can be better prepared and developed.
  • ONC indicated it will be developing an optional 2015 Edition certification criteria set. It emphasized this would be optional and not a requirement for EPs/EHs to maintain good standing in the MU incentive program or EHR vendors to maintain their certification status. The purpose of 2015 Edition would be to address issues found in 2014 Edition and update standards/implementations guides to enhance interoperability. It was not indicated if the 2015 Edition criteria will be released in a separate NPRM or even Interim Final Rule or if it will be released as part of the NPRM for 2017 Edition criteria.
 

But, the proposal does NOT state the following:

  • It does NOT say that CMS/ONC will delay the requirement for EPs/EHs to have EHRs certified on 2014 Edition criteria for MU reporting in CY/FY 2014. If they were going to delay this start date of 2014 Edition criteria, they would need to be finalizing that now in the Federal Register. By Fall 2014, it would likely be too late. Thus, by the absence of their comments, it should be assumed nothing has changed.
 

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.

Thank you,

Drummond Group Inc.

EHR testing, certifications continue during government shutdown

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,

  • The NIST-hosted test tools are not operational during the government shutdown.
  • The ONC CHPL website is not accepting new submissions as these must be evaluated by ONC personnel before posting. In addition, automated functions on the CHPL, such as website accessibility, product lookup, CMS EHR Cert ID generation, and others should continue to function, but with products that are currently present on the CHPL, as of the CHPL data upload on Sept. 27, 2013.
  • The ONC staff and contractors will not be available for technical support, assistance or programming during this shutdown, so new products’ data will be delayed in being posted to the CHPL site.
 

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.

Drummond Group Introduces Decision Guide for 2014 Edition Testing and Certification

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:

  • A Framework Document that helps software developers focus on the specific 2014 edition criteria, clinical quality measures (CQMs) and testing options that will best support customers. This document bridges the complexity gap between the ONC criteria and the necessary Meaningful Use measures.
  • An optional Wave Testing Approach that enables vendors to incrementally test for various certification criteria in phases, instead of all at once. This approach helps bridge the marketing gap between testing and certification that enhances opportunities for early adopters by offering as many as three certification points.
  • A Pre-Test Assessment Tool to gauge testing readiness. The assessment tool bridges the uncertainty gap between development and testing by helping the clients determine their preparedness which can lead to more successful test results.
“The complexity involved with testing and certifying for the ONC criteria with the different Meaningful Use choices is so large that it could easily overwhelm and discourage many vendors.  As a software certification body, we can’t make the requirements less demanding, but we can offer informative tools that make it possible for vendors to quickly gain much-needed insight into their certification needs and testing readiness,” says Kyle Meadors, Drummond Group’s Director of EHR Testing. “And, we can offer a software testing approach that makes the process more palatable for vendors. Having worked with hundreds of software vendors over the years, Drummond Group knows what the vendor is facing in software testing, certification, as well as product development and marketing. As such, we have a genuine understanding of the myriad of challenges that vendors face in preparing their customers for implementing Stage 2. We are confident that the Decision Guide to 2014 Edition can help organizations navigate the new requirements more successfully.”

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 receive the Decision Guide to 2014 Edition or to get additional information about Drummond Group’s Wave Testing Approach, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

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.

Sincerely,

Drummond Group

Important Update on 2014 Edition Testing

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:

  • It is anticipated that the opening date to begin testing and certification for 2014 Edition criteria is Jan. 2, 2013, pending accreditation and approval by ONC, ANSI and NVLAP. ATLs and ACBs will receive specific accreditation instructions from ANSI and NVLAP in December, and Drummond Group will be working diligently to attain approvals from both NVLAP and ANSI within the required deadlines to begin testing and certification on Jan. 2, 2013.
  • Drummond Group will be announcing 2014 EHR Testing and Certification Program details during the week of Dec. 17.
  • Drummond Group has built a series of customer support tools to help calm the complexity of 2014 Edition testing.
  • In the ONC-HIT Certification program, companies now have a choice on where to test and/or certify your product. Drummond Group has now reviewed and certified more than 700 EHR products since opening our EHR doors in 2010.  Needless to say, the Drummond Certification Body, which is separate from our EHR Test Lab, has gained insight, knowledge and experience in the understanding of EHR healthcare products over this time.  We look forward to working with you in testing and certification in the new year.
  • If you have specific questions on EHR 2014 Edition testing and/or certification, please call Tracy LaRue at 512-826-2938 or email This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..
 

We appreciate your interest in our programs and look forward to working with you in the new year!

Sincerely,

Drummond Group Team

ONC Releases FAQ on Price Transparency and Reporting for 2014 Edition

Dear EHR Community,
In our last newsletter, we discussed the changes in the ONC's Permanent Program with respect to public test reports and vendors' price transparency in their certification marketing.
ONC has now clarified that those two issues are being postponed until the testing and certification of the 2014 Edition criteria begins next year. Therefore, it will not impact any testing or certification for the 2011 Edition criteria.

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

Thank you,

Drummond Group Inc.

ONC releases drafts of test procedures for 2014 Edition; Drummond Certified "2011 Edition" seal available

Recently, the Office of the National Coordinator for Health Information Technology (ONC-HIT) released several waves of draft test procedures for the 2014 Edition criteria. You may find them here. Each wave will have a two-week comment period. We strongly encourage all vendors to review them and post any comments or suggestions to ONC via the This email address is being protected from spambots. You need JavaScript enabled to view it. email address. All submissions should include "Test Procedure" in the subject line.

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.

Although continuing to use the previously issued logos is perfectly acceptable and does not impact your certification standing, Drummond Group is offering any company with a certified product our new logo with the "2011 Edition" text. If your company's product(s) were certified beginning in 2010 through present, and you would like to utilize the Drummond Certified "2011 Edition" seal in your marketing, including websites, internal pages, brochures, etc., please email Olga Finneran (This email address is being protected from spambots. You need JavaScript enabled to view it.) and you'll receive this seal in the design format specific to your products' certification (modular; complete ambulatory or complete inpatient). Please reference your certified product and its ONC certification ID in your request. Please allow four weeks to receive the new logo.

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.

Thank you,

Drummond Group

ONC's draft test procedures for the 2014 Edition criteria

 

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