Sunday, October 16, 2016

ONC to Boost Oversight over EHR Usability, Patient Safety Woes

ONC (The Office of the National Coordinator for Health Information Technology at HHS, is reportedly getting more authority to oversee HIT quality.

Some initial observations:

(1) More government control of yet another healthcare domain may be a double-edged sword, BUT:

(2) Something had to be done about HIT, and this initiative could have a good outcome if not overwhelmed too much by corporate and inter-party politics (in our current environment, that is far from assured), and

(3) It validates what we have been writing about on this blog since 2004, and elsewhere on my part since about 1998.

I am also bolding passages I find of most interest.  Emphases mine:


Health Analytics

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.
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.

What have we written about for years here?  Problems including but not limited to:

  • EHR usability
  • Patient safety
  • Workflow design flaws

I hope my efforts and those of other "HIT iconoclasts" (a term that was often used pejoratively) has helped spur recongition of these problems and the resultant action.

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.

What else have we written about for years here?  Problems including but not limited to:

  • lost hours (person-years, really) of clinician productivity,
  • insufficient interoperability (although my emphasis has been that we musst have basic operability before interoperability)
  • Ill-conceived, ill-implemented, discombobulated user interfaces that force dangerous workarounds (e.g., my 2009 ten-part series "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients?" at

(Such EHR problems as the six items above led to the 2011 death of my own mother.)

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.

I add "IT-based data integrity mistakes" as well.

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.

I recall this 2010 statement from ONC Chair Blumenthal.  From my May 3, 2010 post "David Blumenthal on health IT safety: nothing to see here, move along" at


Blumenthal said that although an advisory committee concluded that more information was necessary, he called the evidence of the reports “anecdotal and fragmented” at best ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

I opined that "Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final."

(Just sixteen days after that post, on May 19, 2010, an EHR-related medication reconciliation failure caused my mother to suffer severe injuries, that led to her crippling and death.)

I was right, ONC was dead wrong, and I'm sure ONC hates me for that reason.  From a blog post here:

... Edmund Burke correctly predicted the outcome of the French revolution. He also provided the reasons why it would end in bloodshed. He was vilified, hated and condemned for telling the truth, and when he was proven right, he was hated even more for being right ... The more one tells an ugly truth the more that person is hated. This is because people want a glittering lie to be true. In this we will ignore facts and instead turn to emotion.

Back to the article:

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.” 

Correction:  transparency and accountability, without the "more"; as currently there is little to none.

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.

"Appeasing" is the wrong word.  You appease dictators who do not have the people's best interests at heart.  I would use the word "meeting the intelligent demands of ..."

“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.”

Way too much emphasis on the "Certified" label, which by definition has little meaning, considering the new measures this article described.

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. 

It will be interesting to see how this plays out.  Again, in the current political mess in this country, I am not highly optimistic.

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

There's transparency, and then there's "transparency."  Wonder which one will predominate?

... "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."

Meanwhile, I understand the OCR denies patients rights to their EHR audit trails, which are, in fact, the only way to independently verify if a fraud or tort is being committed upon them i.e., by record alteration....

... 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.  “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

I strongly agree.  That is called pre-market surveillance.

... In addition, we need to create a collaborative for EHR safety, bringing stakeholders together to identify common problems and disseminate best practices.”

In fact, we need robust post-market surveillance and need to disseminate not just best practices, but (as I've written many times over the past ~18 years), disseminate worst practices  - lessons learned - to be avoided.  And not be shy or P.C. about publishing the nasty things that sometimes happen in the HIT ecosystem.

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.

Another wrinkle.

I wish ONC luck.  They'll need it.

I'd offer my help, but as mentioned above, they were spouting industry propaganda at a time when doing otherwise might have prevented a very ugly occurrence involving my late mother.  That's just going to take quite a bit more time to forgive.

-- SS

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