Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

In a sure sign of the times, Drchrono, which offers a free electronic health record platform on the iPad, became the first iPad app to receive official ONC-ACTB certification. According to Healthcare IT News, "the drchrono EHR platform has been awarded ambulatory certification (ONC-ATCB) as a Complete EHR by San Luis Obispo, Calif.-based InfoGard, an Office of the National Coordinator (ONC) Authorized Testing and Certification Body (ATCB)". The app tracks a provider's use of the EHR and offers them key metrics to report to CMS, and includes many other features, such as billing and e-prescribing. 

This is a huge step for a mobile EHR app, but its maker's regulatory hurdles may not be over.  Last week, we reported on the FDA potentially regulating the market of mobile healthcare devices and applications. Electronic and personal health records could be exempt from such regulation, unless the FDA adopts a broad definition of "clinical decision support," which includes decisions based on the information given to a provider via the EHR app or device.

Moreover, use of such mobile apps or devices in healthcare presents providers with a very long list of legal concerns. Privacy and security of patient data, compliance with state and federal laws (including Stark and anti-kickback statutes), assumption of risk and liability, along with many other critical issues, should be addressed in the contract between the healthcare provider and vendor of such software.

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On October 1, 2010, CCHIT announced certifications of 19 "complete" EHR products, including, for example, Epic products for both hospitals and eligible professionals, and Allscripts and GE Centricity products for eligible professionals.  

CCHIT also certified 14 "module" EHR products, from vendors which applied for certification of their products as complete EHRs "but testing could not be completed on a small number of criteria (such as electronic prescribing) because planned updates to the test procedures by NIST were not available at the time of testing." Such "EHR Module" certified products may seek certification as a complete EHRs in the near future.  Via Healthcare IT News:

The Certification Commission for Health Information Technology announced Oct. 1 that it has tested and certified 33 Electronic Health Record products under the ONC-ATCB program.

CCHIT is one of three Approved Testing and Certification Bodies, designated by the Office of the National Coordinator (ONC). The other two are the Drummond Group and InfoGard Laboratories, Inc.

The ATCBs certify that the EHRs are capable of meeting the 2011/2012 criteria supporting Stage 1 meaningful use. Certification is required to qualify eligible providers and hospitals for funding under the American Recovery and Reinvestment Act (ARRA).

The CCHIT certifications include 19 Complete EHRs, which meet all of the 2011/2012 criteria for either eligible provider or hospital technology, and 14 EHR Modules, which meet one or more – but not all – of the criteria.

"CCHIT announces 33 certifications," Healthcare IT News (October 1, 2010).

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According to Karen Bell, MD, chair of the Certification Commission on Health Information Technology (CCHIT), her organization will begin accepting applications for HHS certification as early as September 20, 2010.  Via Healthcare IT News:

CCHIT is authorized to offer HHS certification for complete EHRs that meet all of the Stage 1, 2011/2012 HHS/ONC criteria, as well as certification for modular EHR products that meet one or more - but not all - of the criteria, Bell said.

According to Bell, CCHIT plans to launch its authorized HHS certification program on Sept. 20 at 1 p.m. Eastern time with a Town Call Webcast describing its application and testing process. CCHIT will take new health IT developer applications immediately after the Webcast and the first group of HHS certified complete EHRs and EHR modules will be announced within weeks of that launch.

In addition to HHS certification, CCHIT will continue to offer its CCHIT Certified program for ambulatory and inpatient EHR products that exceed the HHS/ONC criteria and are designed for hospitals and physician practices that are looking for assurance of more robust, integrated EHR products to support the unique needs of its clinicians and patients. Many of these products will also be HHS certified, Bell said.

You can read more about CCHIT's plans here.

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Via HHS Press Release:

The Certification Commission for Health Information Technology (CCHIT), Chicago, Ill. and the Drummond Group Inc. (DGI), Austin, Texas, were named today by the Office of the National Coordinator for Health Information Technology (ONC) as the first technology review bodies that have been authorized to test and certify electronic health record (EHR) systems for compliance with the standards and certification criteria that were issued by the U.S. Department of Health and Human Services earlier this year.

Announcement of these ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) means that EHR vendors can now begin to have their products certified as meeting criteria to support meaningful use, a key step in the national initiative to encourage adoption and effective use of EHRs by America’s health care providers.

“Less than two months following the issuance of final meaningful use rules, we have approved our initial ONC-ATCB certifiers. EHR vendors can begin immediately to get their products certified.” said David Blumenthal, M.D., national coordinator for Health Information Technology. This is a crucial step because it ensures that certified EHR products will be available to support the achievement of the required meaningful use objectives, that these products will be aligned with one another on key standards, and that doctors and hospitals can invest with confidence in these certified systems.”

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Via NIST:

In efforts to help the nation's health care industry make the transition to the digital age in an effective and meaningful fashion, the National Institute of Standards and Technology (NIST) has published a set of approved procedures for testing information technology systems that work with electronic health records (EHRs). Released in draft form earlier this year (see "NIST, Partners Develop Testing Infrastructure for Health IT Systems," NIST Tech Beat for March 16, 2010, at http://www.nist.gov/itl/hit_031610.cfm), the approved and finalized testing procedures are now available for use.

Under a certification program established by the U.S. Department of Health and Human Services Office of the National Coordinator (HHS/ONC), testing organizations authorized by HHS/ONC can use the tools to evaluate EHR software and systems that vendors would like to sell to doctor's offices, hospitals and other health care providers. Starting next year, the federal government will provide extra Medicare and Medicaid payments to health care providers that implement EHR systems certified to meet ONC requirements that conform to technical standards and are put to "meaningful use," performing specifically defined functions.

These ONC-approved test procedures help ensure that electronic health records function properly and work interchangeably across systems developed by different vendors. The set of 45 approved test procedures evaluate components of electronic health records such as their encryption, how they plot and display growth charts, and how they control access so that only authorized users can access their information.

The development of these tools was mandated by the American Recovery and Reinvestment Act (ARRA) in order to support a health IT infrastructure.

Notice of the approved test procedures appears in the August 9, 2010, Federal Register. For more information, see http://healthcare.nist.gov/use_testing/finalized_requirements.html and http://healthit.hhs.gov/certification
 

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On June 18, 2010, the Office of National Coordinator for Health IT issued a final rule, 45 CFR Part 170, establishing a temporary EHR certification program for the purposes of testing and certifying health information technology.

The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR
Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.

You can find the new final rule here.

You can find ONC's "Fact Sheet" and Q&A regarding certification here.

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In a letter to Dr. David Blumenthal, the College of Healthcare Information Executives (CHIME), an organization which represents1,400 healthcare chief information officers, offered some criticism of ONC's recent notice of proposed rulemaking (NPRM) regarding the EHR certification program.  While CHIME expressed general support for a two-stage approach for creating the certifying bodies, the CIO's are worried about any destabilizing effects such rule may have on the health IT market.  Via Healthcare IT News:

We are very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the un-finalized status of meaningful use and certification regulations," CHIME wrote. "The introduction of two separate certification schemes – one temporary and one permanent – carries a risk of continuing the uncertainty and promoting needless product replacement in the marketplace.

CHIME issued a few recommendations to combat such uncertainty, which you can find after the jump.

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