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ONC Boosts Oversight to Fix EHR Usability, Patient Safety Woes

The ONC will now have more authority to look into EHR usability problems that may produce patient safety risks, thanks to a rule that increases oversight capabilities.

- The nation’s quality improvement and payment activities aren’t the only things receiving a federal overhaul this week: the electronic health records that will support clinicians as they implement MACRA and move towards a patient-centered, value-based care environment are also getting some renewed attention.

ONC oversight of patient safety and EHR usability

In conjunction with the publication of the MACRA final rule, the ONC has announced enhanced oversight for the Certified EHR Technology (CEHRT) program, which aims to address some of the usability, patient safety, and workflow design flaws endemic in the current generation of health IT tools.

The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” rule will give the ONC more authority to regulate the design and functionality of certified tools, which form the backbone of most organizations’ health IT infrastructure.  The final rule will be officially published in the Federal Register on October 19, 2016.

A transparent, direct, and more stringent review process may help to reduce the continuous litany of complaints about convoluted workflows, lost hours of productivity, insufficient interoperability capabilities, and frustrating inconsistencies that often prompt users to develop dangerous and unauthorized workarounds.

An increased focus on design and user experience may also help to reduce opportunities for providers to make data integrity mistakes that make big data analytics such a difficult proposition for many stakeholders – and put patient safety at risk due to inadequate communication, lost data, or incorrect inputs.

READ MORE: Can Open Source EHRs Offer a New Path for Health IT Usability?

EHRs are consistently found at the top of patient safety hazard lists from organizations like the ECRI Institute.  The ONC itself has repeatedly acknowledged the danger of inefficient and poorly designed health IT tools, most recently releasing a pair of reports in June that outlined the many dangers of inadequate EHRs, clinical decision support systems, and big data analytics technologies.

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said National Coordinator Vindell Washington, MD, MHCM, in a press release marking the publication of the oversight rule. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.” 

The ONC’s actions may go some way towards appeasing the large number of industry stakeholders who have been calling for increased health IT oversight since the start of the physician burnout epidemic, largely blamed on the shortcomings of EHR technology.

“We recognize that certified health IT often does not operate in a vacuum,” wrote Elise Sweeney Anthony, JD, Director of the ONC Office of Policy in an accompanying blog post.  “In order for ONC to properly evaluate certified health IT, we may have to look at whether certified health IT may fail to perform as it should when it interacts with uncertified capabilities within the product or with other technology.”

The rule allows the ONC to take “necessary action” when CEHRT tools currently in use pose risks to patient safety, and provides an appeal process for the developers of products that come under scrutiny.  ONC will also authorize and oversee accredited testing laboratories (ONC-ATLs) to respond more rapidly to performance issues. 

READ MORE: 6 EHR, Big Data Issues Impede Patient Safety, Cut Quality

The agency is also planning to make the results of their surveillance public in an effort to increase transparency and accountability across the industry.

Information blocking is not specifically mentioned in the rule, but the notion that some EHR products may purposely or inadvertently prevent data exchange across disparate organizations did come up at a House Committee on Oversight and Government Reform hearing earlier this year.

"We certainly are leveraging all the opportunities that we have at ONC and our partners at the Office for Civil Rights and other agencies to see that we're protecting consumers and that data is going to flow," said former National Coordinator Karen DeSalvo to the Subcommittee on Information Technology in March of 2016. “There are areas where we know there may be some opportunity like information blocking where we would need some additional support."

"Since the world has evolved there is a new need for us to have some additional opportunities to protect the people who are using systems and more importantly to protect the data of the consumers.”

Whether intentional or not, EHR systems that do not allow the free flow of information may put patients at risk if they prevent clinicians from making fully informed decisions.  The prevalence of the practice is debatable, but it may also have a significant impact on the ability of healthcare organizations to manage population health across multiple sites of care as MACRA and other accountable care arrangements require.

READ MORE: Alarm Fatigue, Health IT Woes Top ECRI 2017 Patient Safety List

But the ONC’s oversight plans may not go far enough, according to Ben Moscovitch, Manager of the Health Information Technology Initiative at the Pew Charitable Trusts.  Since the rule only focuses on catching flaws in EHRs already being used by providers, the agency is missing an opportunity to engage in some preventative care of their own.

“While it's important to check for safety issues in EHRs that are already in use, there is still more we can do to improve EHR safety,” Moscovitch said in an emailed statement. “For one, we need to test EHRs before they go to market, to detect and address possible flaws ahead of time. In addition, we need to create a collaborative for EHR safety, bringing stakeholders together to identify common problems and disseminate best practices.”

“Electronic health records can have some inadvertent flaws, and some that can cause harm. What this rule does is focus on catching potential issues in EHRs that are already in use, but we should also be working to identify and address these hazards before EHRs hit the market,” he asserted. “That means testing them earlier in the process to catch individual issues, and having stakeholders come together to identify best practices on how to prevent EHR safety problems in the first place.”

The ONC also points out that non-certified products are not on the review agenda – unless the agency needs to examine whether or not they interfere with the function of CEHRT tools.  For providers using a mixture of certified and non-certified technologies, this limitation may be problematic when attempting to remedy workflow issues or patient safety concerns.

Overall, however, the enhanced attention to EHR usability, design, and safety may be a positive development for providers struggling to squeeze a return on their investment from borderline unusable technologies. 

As increasing regulatory pressures make it even more important to have a firm grasp on the big data analytics capabilities and functions of electronic health records, additional safeguards from the ONC may help providers avoid potentially dangerous data integrity and clinical documentation errors.


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