The Health IT Policy Committee's Strategic Plan Workgroup is building the foundation for a "learning health system," the basics of which were presented before the committee during a March 17 meeting.

Paul Tang, chairman of the workgroup and vice chairman of the Health IT Policy Committee, offered a preview of what the learning health system would look like. It begins with the data that is collected and shared through the use of health information technology networks, including data exchanges, electronic medical records and other information that will be made available to providers at the point of care.

"If you apply that data and adequately protect it and combine it with best practices that hopefully result in generating new knowledge, you use that new shared knowledge to improve care, improve outcomes and enhance outcomes," Tang said. "If you take all of these efforts and not only deliver health care to the individuals, but learn from all the individual experiences and learn from the population, we will have a better and continuously improving heath system."

A draft framework, once finalized, will help guide continued health IT expansion from 2011 through 2015, as well as "focus on laying the groundwork for the period beyond 2015 to create a learning health system through the effective use of HIT."

The March 8 draft, in its current form, lists only a broad goal: "Transform the current health care delivery system into a high performance learning system by leveraging heath information technology."

It also lists two guiding principles: "Health information should be used to facilitate rapid learning and innovation in diagnosis, treatment and decision making to improve health outcomes and to enhance health system value," and "HIT should help engage patients and providers to take active roles in creation and application of evidence-based care."

In separate sections looking at objectives and strategies, some common themes emerge, including using health IT to build databases of health information while protecting privacy and security and engaging all stakeholders to help drive the development, adoption and use of health IT through education, research support and other activities.

Tang noted that the next step in the development process is to host a listening session to discuss the strategic framework. The next meeting for the working group is April 6.

Meaningful Use Comments In

The cornerstone for success of the health IT initiatives comes from its meaningful use, the importance of which was underscored by the American Recovery and Reinvestment Act's financial incentives for early adopters of electronic health records and penalties for those who do not use them (¹ Also see "Adoption Of E-Health Records Gets Stimulus Of Medicare Rewards, Penalties" - Pink Sheet, 2 March, 2009.).

Comments from a notice of proposed rulemaking on meaningful use are being reviewed by CMS. That NPRM, issued Dec. 30, 2009, said the definition of meaningful use will evolve over time (² Also see "Health IT "Meaningful Use" Definition To Evolve In Stages, CMS Rule Says" - Pink Sheet, 11 January, 2010.).

A common theme surfacing after a review of the comments is that many stakeholders are concerned with the "all-or-nothing" provisions that would make one eligible for the incentive payments under ARRA: providers have to demonstrate that they are performing a set number of tasks to be deemed a meaningful user.

In March 15 comments, the American Society of Clinical Oncology proposed "a gradual progression towards full compliance of the various stages. For example, an eligible provider would meet 80 percent of the Stage I meaningful use requirements in 2011 and 2012, and in 2013, 100 percent of stage I and 80 percent of Stage II."

Beyond that, ASCO also charges that the all-or-nothing approach "discriminates in particular against small- and medium-sized physician practices without the resources and infrastructure to implement complex clinical information systems. We are particularly concerned that setting the bar too high will discourage oncologists and other [eligible physicians] from adopting EHRs at all."

ASCO also expressed safety concerns related to the rushed implementation. "We are concerned that the aggressive set of requirements and timeframe presented for the EHR incentive program will lead to rushed implementations that risk failure and could pose patient safety concerns, particularly for oncology, which involves complex workflows with highly toxic medications."

The comments note "growing literature" on unintended adverse consequences related to EHR use, including errors accidentally embedded in e-prescribing and computerized order-entry tools.

Joint comments filed March 15 from US Oncology, Altos Solution, Elekta IMPAC Software and Varian Medical Systems echo those concerns: "For radiation and medical oncology - as may be the case with other medical specialties - there are ... meaningful use objectives and measures that simply do not apply or have EHR utilization thresholds that seem inapplicable to the specialty or overly difficult to assess using the measures specified by CMS."

Likewise, the American Society for Clinical Pathology in March 15 comments argued that the meaningful use rules, as proposed, "could have extreme anti-competitive effects on the market to provide anatomic pathology and clinical laboratory services, and could force small- and medium-sized laboratories from the market." The group also says that as written, pathologists will not be able to participate in the meaningful use incentive program, which ASCP says is a "major oversight and must be corrected when the rule is finalized."

The group noted it is poised to be "a leader" as health IT becomes a more integral part of the health care delivery system because it will provide a variety of data that will be key in supporting research, including identifying epidemiological trends and populations of interest; performing population-based genetic association studies; evaluating clinical processes and developing more effective delivery strategies; and informing pay-for-performance.

Even a group focused on spurring adoption of EHRs criticized the all-or-nothing requirements. In its March 8 comments, the eHealth Initiative noted that the NPRM "does not accurately reflect the amount of time it will take providers of all sizes - from the smallest practice to the largest hospital - to efficiently prepare to prove meaningful use, and it does not reflect the different workflows and clinical requirements of different specialties. ... eHI is particularly concerned about the impact of failure by a provider who puts extraordinary effort into meeting the requirements of the program but is not deemed to have earned the incentive because of the all-or-nothing approach to the measures."

Congressional Inquiry Into HIT Safety

Sen. Chuck Grassley, R-Iowa, also has raised questions related to the safety of health IT systems. In a Feb. 24 letter to HHS Secretary Kathleen Sebelius, the ranking member of the Senate Finance Committee expressed his surprise "by the lack of discussion about patient safety concerns when, for example, HIT products are not functioning properly or when they are being used incorrectly."

Grassley continued: "Over the last year, I have heard from many health care providers around the country regarding problems they experienced with implementation and use of certain HIT products in their hospitals and clinics. In most cases, they tried raising their concerns to hospital administrators and/or to the HIT vendors, but they told me that their concerns were often ignored or dismissed."

The senator was seeking information on whether FDA has enough authority to regulate health IT products and to get a clearer picture of what HHS is doing to oversee products to ensure patient safety.

Health IT software is considered a medical device regulated by FDA. During a Feb. 25 meeting of the Health IT Policy Committee Adoption/Certification Workgroup, Jeff Shuren, director of FDA's Center for Devices and Radiological Health, noted that to date, "FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices."

Shuren said HIT safety concerns that have come to light fall into four categories: errors of commission (such as accessing wrong patient file); errors of omission or transmission (such as loss or corruption of data); error in data analysis (including medication dosing errors); and software incompatibility.

Shuren said that in light of the safety issues that have been reported, a framework of federal oversight of health IT is needed to assure public safety. "Any such framework would need to take into account the complex and dynamic nature of HIT systems," he said. "Given the FDA's regulatory authorities and analytical tools, we could potentially, at a minimum, play an important role in preventing and addressing HIT-related safety issues, thereby helping to foster confidence in these devices."

- Gregory Twachtman ( ³ g.twachtman@elsevier.com )

Health IT Strategic Framework Aims To Create A "Learning Health System"

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