Groups offer strategy for regulating health IT

The Bipartisan Policy Center and Health IT Now are calling on the federal government to implement a more modern oversight framework for digital healthcare and HIT that reduces burdens for users and technology developers, fostering innovation while ensuring consumer protections.

On Tuesday, the organizations released a report—based on feedback of a work group of nearly 50 individuals representing patients, providers, and vendors—that lays out principles and recommendations for policymakers to consider as they seek to reduce burdens and advance regulatory reforms.

“Nearly 10 years after the passage of the HITECH Act, the time is now to update the course of federal health IT policy,” states the report.

According to Joel White, executive director of Health IT Now, the report offers a strategy for how HIT should be regulated going forward—which he said was not easy to put together.

“Taxpayers have spent about $38 billion to support the adoption and use of EHRs, but these discrete incentives are winding down—even as technology is taking off in exciting ways,” White told an audience at a launch event held at the Bipartisan Policy Center. “The challenge is that our regulatory structures and federal programs have not kept pace with this innovation. In fact, in some cases, they have hindered the flourishing of creativity and new tools.”

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White noted that practicing physicians spend about half of their workdays on EHRs and desk work, while emergency physicians spend about 44 percent of their time on data entry. “We want to be encouraging more time between the doctor and the clinician and the patient,” he added. “We’ve placed regulatory requirements and rules and process over care and treatment and dialogue and discourse.”

To reform this burdensome regulatory environment, BPC and HITN have recommended an oversight framework designed to address the following six technology areas:

• Interoperability—Technology should facilitate interoperability and information sharing, which play a critical role—along with other technology outcomes—in advancing higher quality, more cost-effective, patient-centered care.
  
• Usability—Technology should reflect evidence-based, user-centered design principles; human factors science; and best practices. It should not create unnecessary burden on end users. It should be culturally competent, enabling access by users with diverse languages and abilities.
  
• Safety—Technology should not create patient harm. Instead, it should help reduce patient harm by supporting the delivery of safer care.
  
• Security—Technology should assure that information is available and accessible only to authorized individuals and processes and also provide assurance that information is not altered or destroyed in an unauthorized manner.
  
• Patient Access to Information—Technology should enable and not create barriers to patients’ access to their own health information.
  
• Support for an Evolving Health Care System—Technology should be adaptable and flexible enough to meet the changing needs of users and an evolving health care system.
  

Specifically, the report calls for “careful review and reduction or elimination of prescriptive technology requirements contained in the Centers for Medicare and Medicaid Services’ (CMS) quality improvement, payment, and delivery system reform programs and an overhaul of the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program, building upon CMS and ONC efforts currently underway to reduce burdens and advance regulatory reforms.”

“Congress and the administration have an excellent opportunity to build a better system that both accelerates innovation and protects patients,” said Janet Marchibroda, director of BPC’s health innovation initiative. “Competition and incentives can produce innovative tools that ultimately help providers and patients deliver and receive high-quality, cost-effective, and patient-centered care.”