• Industry Watch •
CCHIT to Certify PHRs
The Certification Commission for Health Information Technology (CCHIT) has begun development of its 2009 certification program by announcing the formation of a personal health records (PHR) advisory task force. This is in addition to its 10 electronic health record (EHR) Work Groups. The 17-member advisory task force includes members from healthcare, governmental organizations, advocacy groups and business. The 10 work groups will update criteria for ambulatory, inpatient and emergency department EHRs as well as optional child health and cardiovascular certifications. Other groups will focus on interoperability, security and privacy. Although this does not mean the commission will begin certifying PHR products, it sets the groundwork for a possible future program, or perhaps inclusion of PHR criteria in existing EHR certification, according to CCHIT Chairman Mark Leavitt, M.D.
Medication Reconciliation Inaccuracies
Medication reconciliation takes center stage again as a new study published in the
Annals of Emergency Medicine shows mounting inaccuracies, particularly for trauma patients in rural populations. The study, titled, “Medication Reconciliation in a Rural Trauma Population,” studied 234 trauma patients in a rural setting. Findings showed an 85 percent inaccuracy rate for medication lists given upon admission. According to lead study author S. Lee Miller, M.D., it is the lack of a good system for recording all of a patient’s medications that accounts for medicine-related errors being the costliest “disease” in America today.
$15.5 Million Rural Broadband Network Grant
The Federal Communications Commission (FCC) has awarded a $15.5 million grant to the Center for Telehealth and Cybermedicine Research at the University of New Mexico’s Health Sciences Center to design, build, operate and evaluate the Southwest Telehealth Access Grid — a broadband network meant to serve rural areas lacking the technology. The network grid will support rural connections to more than 500 sites in New Mexico and Arizona, along with several Indian Health Service sites in Colorado, California, Nevada, Texas and Utah.
The grant will be disbursed over three years and is derived from the Rural Health Care Pilot Program, which is dedicated to establishing statewide and regional broadband telehealth networks throughout the United States. So far, the FCC has given more than $417 million to establish such grids in 42 states and three U.S. territories. Funding is derived from the FCC Universal Service Fund Fee collected from long distance and wireless telephone subscribers to help pay for Internet service to schools, libraries, low-income populations and rural communities.
The original grant proposal, which was submitted by the Four Corners Telehealth Consortium, was one of 69 applications chosen from a total of 81. The Consortium includes directors of state-based telehealth/telemedicine programs headquartered at the Universities of Colorado, New Mexico, Utah and Arizona. The Arizona Telemedicine Program (ATP) at the University of Arizona College of Medicine will receive $875,000 for their portion of the project. ATP founding director Ronald S. Weinstein was co-author of the original proposal. “We anticipate that access to secure high-speed communications via national network backbones such as Internet2 and National LamdaRail will be important for telemedicine applications that are under development, such as three- dimensional imaging,” says Dr. Weinstein.
Dale Alverson, M.D., medical director of the Center for Telehealth at the University of New Mexico’s Health Science Center also commented on how the grid will allow people to switch into emergency mode for disasters or emergencies, such as a pandemic. Los Alamos National Laboratory will do computer modeling of the system in advance to test how well it would function in emergencies or disasters and look for weaknesses so builders can avoid costly mistakes. The project has five years to complete the infrastructure. Creation of a regional system of telehealth for the American Southwest is being hailed as a major step toward a nationwide broadband network for telehealth.
Ohio Hospitals Expand Telemedicine
A central Ohio telemedicine project will expand its reach in serving the southeast part of the state as well as parts of Virginia. Last year, Ohio Telemedicine formed a partnership with the Division of Neonatology at Nationwide Children’s Hospital in Columbus and the Ohio Supercomputer Center (OSC) to link neonatologists with pediatricians at Adena Health System in Chillicothe, Ohio. Physicians utilize OSCs high speed optical network, which has more than 1,850 of fibre, to transmit images and allow neonatologist to collaborate with pediatricians on long distance exams via videoconferencing technology. Pediatricians at Adena have utilized the connection nearly 100 times, resulting in a 50 percent reduction in patient transfers. Nationwide plans connecting to an additional hospital in Zanesville, Ohio as well as four other rural hospitals in the state later this year.
RFID EMI Poses Medical Equipment Hazard
A recent study published in the June 24 edition of the Journal of the American Medical Association (JAMA) shows findings of possible patient risk due to interference between radio frequency identification devices (RFID) and some medical devices. The study was co-authored by two physicians at the Academic Medical Centre of the University of Amsterdam, the Netherlands. The study, which was conducted in a controlled non-clinical setting, was designed to assess and classify incidents of electromagnetic interference (EMI) by RFID on critical care equipment.
The assessment was made in proximity to 41 different medical devices spanning some 17 different categories and 22 manufacturers. The researchers utilized two types of RFID systems — one passive (868 MHz), which must be activated and powered by an EMI field generated by a reader in order to transmit information, and an active system (125 kHz), which is powered by batteries and can collect, store and broadcast the information without reader activation.
Some 123 tests were conducted with devices such as external pacemakers, infusion/syringe pumps, dialysis devices, defibrillators, mechanical ventilators, monitors and anesthesia devices. The 41 medical devices were submitted to three EMI tests each, constituting the total of 123. Out of that total, there were 34 incidents of EMI interference with 22 categorized as hazardous; two labeled as significant in that they influenced monitoring to a degree, causing a distraction from patient care; and, 10 were defined as light in that they influenced monitoring without requiring a significant level of attention.
Hazardous incidents included: ventilation rate changes and total switch-offs of mechanical ventilators; complete stoppage of syringe pumps; external pacemaker malfunctions; complete stoppage of renal replacement devices; and, electrocardiogram interference in atrial and ventricular electrogram curves read by the pacemaker programmer. Results showed that the passive RFID systems produced a significantly greater proportion of interference (44 percent difference) and hazardous incidents (27 percent difference) than the active systems. The median distance between reader and device where all instances occurred was 11.9 inches while hazardous incidents occurred at a median distance of 9.8 inches.
The authors acknowledge that the study was limited by the generalization of the incidents and applied only to the two types of RFID systems evaluated. The systems were also tested at full power to evaluate worst-case scenarios and no patients were involved in the study.
Peper Long, a Food and Drug Administration (FDA) spokesperson acknowledged that the agency was aware of potential problems but had received no reports of injuries directly caused by EMI with hospital devices. The FDA is testing some medical devices to determine vulnerability to EMI and the extent that the vulnerability may pose to public health. This is the first safety study dealing with RFID, which is widely used by hospitals to wirelessly tag medical equipment and even patients. The Dutch Ministry of Health, Welfare and Sport, the Ministry of Economic Affairs, the Academic Medical Center, Capgemini, Geodan, Oracle and Intel funded the study.
Final Certification Criteria Published
The Certification Commission for Healthcare Information Technology (CCHIT) has published its approved final criteria for certification of inpatient and emergency department (ED) electronic health record (EHR) products, as well as an enterprise EHR certification for vendors that provide ambulatory, inpatient and ED EHRs that are interoperable. The first round of applications for certification under the new 2008 criteria will be accepted Aug. 1-14, with certified products expected to be announced in November. The final certification criteria, test scripts and associated program policy documents are published on the Commission’s Web site. A town call teleconference for vendors interested in certification was scheduled for July 10 to introduce the new programs.
The publication of the materials concludes the commission’s development work on EHR certification for the CCHIT Certified 2008 program. The Commission published the final ambulatory, child health and cardiovascular medicine criteria May 20, with acceptance of certification applications ending July 14.
According to Mark Leavitt, M.D., Ph.D, chair of CCHIT, “Ambulatory and inpatient EHRs must now be able to send and receive clinical summaries in the CCD format — making basic elements of health records, such as medications and allergies, interoperable and portable for the first time. And, with new health IT adoption incentive programs — such as the Centers for Medicare & Medicaid Services EHR demonstration project now being launched — vendors serious about the EHR market will want to attain 2008 certification.”
CCHIT further announced the following vendors will participate in pilot tests to fine tune inspection processes of 2008 certification programs: Cerner Corp., EDIMS LLC, Emergisoft Corp., Epic Systems Corp., Greenway Medical Technologies, NextGen Healthcare Information Systems, and Wellsoft Corp.
Subcommittee Approves HIT Legislation
The Subcommittee on Health recently approved H.R. 6357, the “Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008” or the PRO(TECH)T Act, which was forwarded to the full Committee by voice vote. The bipartisan legislation is designed to strengthen the quality of healthcare, reduce medical errors and costs by encouraging the adoption of health information technology (HIT), and providing greater privacy and security to health information. The legislation promotes the nationwide adoption of an HIT infrastructure and establishes incentives for doctors, hospitals, insurers, and the government to exchange health information electronically across the country. H.R. 6357 also makes permanent the Office of the National Coordinator for Health Information Technology (ONCHIT) at the U.S. Department of Health and Human Services while furthering the goal of an electronic health record for each person in the U.S. by 2014. The legislation also strengthens the law protecting the security and privacy of an individual’s health information through provisions such as requiring notification when personal health information is breached.
H.R. 6357 builds on a discussion draft released by Representatives John Dingell, D-Mich., and Frank Pallone, D-N.J., along with Representatives Joe Barton, R-Texas, Ranking Member of the Committee on Energy and Commerce, and Nathan Deal, R-Ga., Ranking Member of the Subcommittee on Health, on May 22, 2008. On June 4, 2008, the Subcommittee held a hearing in which witnesses from the Administration and representatives from consumer, technological, and privacy groups provided feedback on the draft legislation.
Additional information on H.R. 6357 is available on the Committee’s Web site at
http://energycommerce.house.gov.
HHS Considers Including Genetic Data in EHRs
The American Health Information Community (AHIC) is recommending that the federal government prepare for a future health IT landscape that includes storage of genetic data within electronic health records (EHRs) and personal health records (PHRs) so that doctors can match medical treatments to their genes.
AHIC has recommended that The National Library of Medicine, which already has taken a lead role in some of the work being done by the Department of Health and Human Services (HHS) on genetic information, head the effort to integrate genetic information into EHRs or PHRs.
One of the recommendations calls for HHS agencies and the National Institute of Standards and Technology to clarify and determine the role that each would play in standardizing pharmacogenetic data. Another recommendation calls for the National Institutes of Health and other federal agencies involved in research to develop best practices for patients to consent to uses of their genetic data.
Although progress has been made in terms of privacy protections when it comes to genetic data with the Genetic Information Nondiscrimination Act of 2008 (GINA), a great deal of work is yet to be done in parsing the realities of that decision throughout the healthcare continuum. GINA aims to protect the privacy of all Americans’ genetic information and to establish a national and uniform basic standard necessary to fully protect the public from discrimination based on genetic information.
Scientists are beginning to make connections between patients’ genetic characteristics and responses to particular medications. For example, certain breast cancers are linked to the patient’s genes, and those cancers can be treated more effectively now that the connection is understood.
Proposed Controlled Substance ePrescribing Rule
The Drug Enforcement Administration (DEA) has proposed a rule that will allow for controlled substances to be ordered electronically, thereby permitting pharmacies to receive, dispense and archive these electronic prescriptions, according to the proposed rule. Additionally, the proposed regulation would reduce paperwork for DEA registrants who dispense or prescribe controlled substances and has the potential to reduce prescription forgery.
The proposed regulations would be an addition to, not a replacement of, the existing rules. Pharmacists have pushed for this practice to be authorized since 2001 when the DEA issued an advanced notice of proposed rulemaking on the topic. It took until 2005 for the agency to begin to examine how to revise its rules to permit electronic prescriptions.
The DEA has held back, chiefly due to concerns over drug diversion. DEA Deputy Assistant Administrator for the Office of Diversion Control, Joseph Rannazzisi, said “Our goal is to put in place an electronic prescribing system that is efficient, medically beneficial to patients and prescribers, and provides security from hackers and others who might seek to engage in fraudulent prescribing activities.
It is also essential that electronic prescribing of controlled substances take place in a manner that allows for reliable prescribing records so that the prescribing practitioner and the pharmacist who fills the prescription can remain accountable for their actions — just as they always have been when using paper prescriptions.”
The 62-page rule, published in the June 27 Federal Register, seeks comments by Sept. 25. The full text is available at
gpoaccess.gov/fr/index.html.