iPad EHR app certified for meaningful use

Posted on August 1, 2011 by Steve Fox and Vadim Schick

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.

"iPad EHR gains meaningful use certification," Healthcare IT News (July 29, 2011).

"FDA's mobile medical app guidelines get everybody talking," Healthcare IT News (July 26, 2011).

 
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CHIME comments on EHR certification NPRM

Posted on April 15, 2010 by Steve Fox and Vadim Schick

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.

CHIME called for:

  • Temporary process to be a provisional or interim one that builds on current certification strategies and is "harmonized" with the eventual permanent certification process. According to CHIME, certification process should be the responsibility of the vendor, and that the purpose of certification should be to provide healthcare providers and professionals with assurance that the product they are purchasing can help them achieve meaningful use.
  • More specificity in language to define what constitutes a self-developed EHR. Current wording in the regulation suggests that any complete EHR or EHR module that's modified by a healthcare provider or a contractor could require certification.
  • Changes in certification requirements be made only when they are necessary to meet meaningful use evolution or advance interoperability, not just because a certain amount of time has passed.
  • If CMS maintains the "adoption year" approach originally advanced in proposed regulations, providers should not be required to have products certified for capabilities not required in their current adoption year.
  • Individual EHR modules be certified to ensure that they can communicate according to adopted standards, and that the interoperability of those modules as used by providers be deemed as certified.
  • HIT vendors fully disclose functions for which their products are certified and fully disclose known compatibility issues.
  • In the event of a certification body losing its authority to certify products, vendors should have six months to recertify products, and providers should not be penalized for a change in a product's certified status if they are still able to demonstrate the meaningful use of the technology.

"CHIME raises concerns about EHR certification," Healthcare IT News (April 9, 2010).
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In the news: medical ID theft on the rise; CHIME comments on meaningful; and more

Posted on March 24, 2010 by Steve Fox and Vadim Schick
  • Javelin Strategy & Research survey found over 275,000 cases of medical identity theft in 2009, with an average price tag greater than $12,000 per incident.  This is twice as many cases as in 2008.  Keeping health information safe is going to be of paramount importance in the next decade, especially considering the steep rise in use of electronic health records. According to Computerworld.com (citing a study by IDC, a research firm), "about a quarter of all Americans -- 77 million people -- already have an EHR, up from 14% from in 2009." By 2015, experts believe the number will reach up to 60%, partially due to the transformation of the health IT industry by the HITECH Act.
  • In its comments to CMS regarding the meaningful use NPRM, College of Healthcare Information Management Executives (CHIME) insisted that the present "all or nothing" approach to achieving meaningful use is going to prevent significant numbers of eligible providers from receiving any incentive payments under the HITECH Act.  According to American Medical News:

Among CHIME's suggestions: a gradual implementation process that would allow physicians to qualify for incentives by achieving 25% of meaningful use objectives by 2011, 50% by 2013, 75% by 2015, and 100% by 2017.

'Without an approach that rewards progress or provides sufficient time, organizations with limited resources will likely have little chance of qualifying for payments, thus widening the 'digital divide' in the country,' CHIME wrote.

  • U.S. Senate passed a bill which, if approved by the House and signed by the President, would limit the definition of "hospital-based" eligible professionals to just those practicing in an inpatient or emergency room hospital setting.  If passed, this change would make the Medicare and Medicaid EHR incentive payments available to a far wider range of eligible professionals.
  • CCHIT may be getting some competition from the Drummond Group, which announced plans to become an ONC-authorized certifying body of EHR technology (ONC-ATCB).

"U.S. Senate backs expanded physician eligibility for MU," HealthImaging.com (March 11, 2010).

"Drummond Group in EHR testing for the 'long term'," Healthcare IT News (March 12, 2010).

"Patient Billed for Liposuction as Medical Theft Rises," Bloomberg.com (March 23, 2010).

"As health data goes digital, security risks grow," Computerworld.com (March 22, 2010).

"EMR meaningful use rules warrant gradual approach," American Medical News (March 17, 2010).
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