Life Science Compliance Update

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March 12, 2018

US Health IT Policy Lags Behind

Health Data

As described in a recent opinion article, Health IT Now and the Bipartisan Policy Center convened a work group of organizations representing clinicians, patients, hospitals, and technology companies to assess the current regulatory landscape, identify the most pressing needs of users, and develop consensus on the ideal future role of government in a post-meaningful use era, and a rapidly evolving delivery system and technology environment. Their report can be accessed and read here.

“For too long, federal regulation of health IT favored reporting and process over care and treatment. HHS must create a new era in which government rules provide tangible benefit to consumers; doctors see patients, not computer screens; and the private sector propels our health care system into the future without fear of an outdated regulatory framework holding us in the past. We have envisioned a system that is suited for the health IT challenges and opportunities of tomorrow. We want to make sure Washington sees that vision, too,” writes Janet Marchibroda, director of the Health Innovation Initiative for the Bipartisan Policy Center, and Joel White, executive director of Health IT Now.

Report and Recommendations

The work group members came together with the common understanding that while robust specifications were helpful in the early stages of HITECH implementation, over time, the level of prescriptiveness regarding health information technology (IT) contained within the Centers for Medicare and Medicaid Services (CMS) Electronic Health Record (EHR) Incentive Programs, CMS’ Merit-based Incentive Payment System (MIPS), and the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program, have contributed to dissatisfaction and increased burden among technology users and developers.

As a result, the work group’s report made several recommendations. Broadly, they encourage the federal government to provide assurances that protect consumer protections while leaving the evolution of products to the private sector. Additionally, the federal government’s role should continue playing a role in non-regulatory ways, like funding research to identify successful practices and adopting standards within health IT to signal government support.

The work group agreed on the following key principles for an ideal oversight framework for health IT and digital health:

  1. Encourage innovation by being flexible, technologically neutral, and not overly prescriptive; encouraging good development processes, rather than specific features and functions; supporting minimally necessary standards and baseline protections; and avoiding creation of unreasonable barriers to entry.
  2. Be risk-based, assuring that the level of oversight is based on the risk of harm to patients.
  3. Be stable and predictable, meaning that any changes must be implemented with sufficient notice and not create or add to uncertainty.
  4. Be accountable to the public and enforceable, by gaining considerable input, making performance transparent, and assuring enforcement, as applicable.
  5. Reflect the principles of a learning health system, by undergoing continuous improvement and innovation and embedding best practices as new knowledge is captured through experience.

The oversight framework should address the following six technology outcomes:

  1. 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.
  2. 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.
  3. Safety. Technology should not create patient harm. Instead, it should help reduce patient harm by supporting the delivery of safer care.
  4. 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.
  5. Patient Access to Information. Technology should enable and not create barriers to patients’ access to their own health information.
  6. 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.



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