Monday, October 11, 2010

Standards Update

The House Committee on Science and Technology’s Subcommittee on Technology and Innovations held a hearing to discuss the integration of IT with healthcare as a means to improve patient care and lower escalating healthcare costs.

Subcommittee Chairman David Wu (D-OR) stated, “We still have a ways to go in promoting interoperability, coordinating the many health IT projects underway, governing the standards development process, and providing direction on privacy and security.”

David Blumenthal, MD., National Coordinator, HHS Office of the National Coordinator for HIT, briefed the Subcommittee on the standards work needed beyond Meaningful Use Stage 1. As Dr. Blumenthal explained, the HIT Standards Committee will focus on the standards implementation specifications and certification criteria necessary for future stages of meaningful use. The Committee will work to achieve agreement on vocabularies and on code sets for particular exchange purposes.

He said the Standards Committee plans to issue recommendations on strengthening the security capabilities of EHR technology and issue standards for electronic health information exchange in support of meaningful use.

ONC has issued a final rule establishing a temporary certification program for HIT that outlines how organizations can become ONC-Authorized Testing and Certification Bodies (ONC-ATCB). Dr. Blumenthal said a final rule for a permanent certification program is expected to be published later this year and is expected to be fully operational in early 2012.

He expects that this program will be more rigorous than the temporary certification program and will achieve greater incorporation of international standards and best practices through requirements such as accreditation and surveillance.

Kamie Roberts, Associate Director, Information Technology Laboratory at NIST, appearing before the Committee, described NIST’s role in developing standards. Currently, NIST plays a critical role by participating early in the development process and by helping to ensure that the infrastructural standards are complete and unambiguous. NIST priorities are to develop security, usability, along with medical device and terminology standards.

NIST’s standards role for HIT is to:

• Collaborate with organizations and federal agencies including HL7, IEEE, ISO, and Integrating the Healthcare Enterprise, to refine current standards and develop future standards needed for the next stages of meaningful use criteria in 2013 and 2015

• Play an important role in testing activities including developing test tools and associated testing infrastructure and also study how to reduce costs in developing health IT systems

• Collaborate with HHS and the ONC to help develop a program for the voluntary certification of health IT systems that will be in compliance with applicable certification criteria to meet meaningful use.

Roberts made suggestions as to where longer-term health IT standards development, research, and outreach activities are needed:

• Standards need as the use of emerging technologies such as body sensors, implants, and medical equipment are used for routine monitoring of chronic conditions. Current research is being done to analyze the impact of interference from such devices and to study how energy obtained from human movement can be used to power the devices

• Standards and guidelines are required so that medical records can be retrieved regardless of the format and medium where they are first created or stored. Having the ability to preserve records will enable doctors to create medical records for children and be able to access the same medical records when the children are adults.

• Standards and terminologies are needed to accommodate changing technologies and advances in biomedical knowledge

• Standards are important when information needs to be retrieved from notes in EHRs where data is not formatted or structured

• Standards are needed to control image quality so that colors viewed on a digital image by a medical practitioner are representative of the actual colors when viewed in person

The organization HIMSS has some concerns regarding standards. Joyce Sensmeier HIMSS Vice President for Informatics, testifying at the hearing, urges HHS to publish criteria pertaining to Meaningful Use Stage 2 at least 18 months before the beginning of Stage 2. This will enable sufficient time to develop, test, and deploy software conforming to these standards and implementation guides.

She also explained that beyond the specific concerns associated with the Standards, Implementation Specifications and Certification Criteria for Meaningful Use Stage 1, HIMSS is concerned that meaningful use and interoperability will be hindered without addressing the patient identity solution and security needed for personal health information.

Richard Gibson M.D., PhD, President, Oregon Health Network made suggestions on some new national standards that are needed. For example, standards to transmit provider text notes, to export and import patient information directly between EHRs and between provider-to-provider, for document transfer to help providers using paper records, a standard EHR functionality requirement for quality measure reporting, plus a national model is needed for privacy and patient consent, access control, and availability of the entire health record.