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Has EHR Become a Bad Brand?

Note: This was first published on emrandhipaa.com

The other day, I had lunch at DC’s Soupergirl with the redoubtable Chuck Webster, workflow tool maven and evangelist. We talked a lot and discovered that both of us had a warm spot for the classic neighborhoods near Atlanta’s Piedmont Park. He as a transplant and I as a native.

More to this blog’s point, we discussed the state of EHRs and their numerous problems. Chuck wondered if EHR, per se, had become a bad brand? It’s a good question. Have we seen a once promising technology become, as has managed care, a discredited healthcare systems? It’s an easy case to make for a host of reasons, such as these:

Poor Usability. There are scads of EHRs in the marketplace, but few, if any, have a reputation as being user friendly. Whenever I first talk to an EHR user, I wait a few minutes while they vent about:

  • How they can’t put in or get out what they need to,
  • Their PCs being poorly located, inflexible or the wrong footprint,
  • Data that’s either missing, cut off or hard to find,
  • Logging in repeatedly,
  • Transcribing results from one system to put it in another,
  • Wading through piles of boilerplate, to get what they need etc., etc.
  • Having to cover PCs with sticky note workarounds.

As for patients, my friend Joe, a retired astrophysicist, is typical. He says when his doctor is on her EHR she doesn’t face him. She spends so much time keying, he feels like he’s talking to himself.

Now, it’s not completely fair to blame an EHR for how it’s implemented. The local systems folks get a lot of that blame. However, vendors really have failed to emphasize best practices for placing and using their systems.

Missing Workflows. EHRs, basically, are database systems with a dedicated front end for capturing and retrieving encounters and a back end for reporting. To carry out, their clinical role they have to be flexible enough to adapt to varying circumstances with a minimum of intervention.

For example, when you make an appointment for a colonoscopy, the system should schedule you and the doctor. It should then follow rules that automatically schedule the exam room, equipment, assign an anesthetist, and other necessary personnel, etc.

When you come in, it should bring up your history, give your doctor the right screens for your procedure, and have the correct post op material waiting. General business software workflow engines have done this sort of thing for years, but such functions elude many an EHR. EHRs without needed workflow abilities increase staff times and labor costs. They also mean users miss important opportunities and potential errors increase.

Data Sharing. Moving from paper to electronic records promised to end patient information isolation. Paper and faxed records can only be searched manually. However, with a structured electronic record, redundant entry would be reduced and information retrieval enhanced. Or so the argument went, but it hasn’t worked out that way.

While there are systems, such as the VA, Kaiser and various HIEs that fulfill much of the promise, it is still a potential rather than a reality for most of us. There are two basic reasons for this state of affairs: ONC’s mishandling of interchange requirements and one member of Congress’ misplaced suspicions.

ONC’s Role. ONC’s Meaningful Use program is meant to set basic EHR standards and promote data interchangeability.

When it comes to these goals, MU fell down from the start. MU1 could have been concise requiring an EHR to capture a patient’s demographics, vitals, chief complaint and meds.

Most importantly, MU could have made this information sharable by adopting one of HL7’s data exchange protocols. This would have given us a basic, national EHR system. Instead, MU focused on too many nice to have features, leaving data exchange way down the list.

ONC has tried to correct its data interchange a failing in MU2 to a degree, but it’s not there yet. Here’s what GAO, has to say about ONC’s efforts:

HHS, including CMS and ONC, developed and issued a strategy document in August 2013 that describes how it expects to advance electronic health information exchange. The strategy identifies principles intended to guide future actions to address the key challenges that providers and stakeholders have identified. However, the HHS strategy does not specify any such actions, how any actions should be prioritized, what milestones the actions need to achieve, or when these milestones need to be accomplished. GAO Report-14-242, March 24, 2014. Emphasis added.

Ron Paul. The other important obstacle to interchange came from Congress. When Congress passed HIPAA in 1996, it mandated that HHS develop a national, patient ID. However, in 1998 Ron Paul, (R-TX) deduced that since HHS wanted the ID system, it therefore wanted to put everyone’s medical records in a government database. He saw this as a threat to privacy. He got a rider added to HHS’s budget forbidding it to implement the ID system or even discuss one.

The ban’s remained in succeeding budgets. The rider has created a national medical data firewall for each of us, which hinders all of us. Paul’s gone from Congress, but Congress continues the ban. As Forbes’ Dan Munroe wrote about Paul’s ban:

The health data chaos we have today doesn’t allow for interoperability, portability or mobility. It’s why fax machines remain the ‘lingua franca” of U.S. healthcare. Every healthcare entity in the U.S. sees each patient, event and location as unique to them. For lack of a single identifier, there’s no easy or cost-effective way to coordinate patient care. Emphasis added.

While the lack of a patient ID is not EHRs fault, it noticeably reduces their ability to interchange information. State or other HIE’s are, in effect, workarounds for lack of a uniform ID. This situation adds to the perception of EHRs as unresponsive technology.

Onerous Agreements. As many an EHR buyer has found, vendors see EHRs as a sellers’ market. They use this to write onerous license agreements exempting their products from adhering to standards such as MU or from responsibility for costly errors or omissions.

These agreements not only limit liability, but often silence a buyer’s adverse comments. The effect is to cut buyers from any meaningful recourse. This shortsighted practice adds one more layer to the EHR industry’s image as unresponsive, self serving and defensive.

Whither the Brand?

The question then is are things so bad that EHR needs rebranding? If so, how should this be done by calling EHRs something else, advocating for a different technology, or yet another alternative?

For some brands, a new name along with some smart PR will do. That’s how Coca Cola reversed its New Coke fiasco. EHRs have a tougher problem. EHRs are not a one vendor product. They are a program class. Reforming EHR’s brand will take more than effective PR. It will take pervasive technical and policy changes.

Change From Where?

Change in a major technical field, as in public policy, requires either overcoming or going around inertia, habit, and complacency. EHRs are no exception. Here are some ways change could happen.

External Events. The most likely source of change is a crisis that brings public pressure on both the industry and government. There is nothing like a tragedy to grab public attention and move decision makers off the dime. I don’t want it to occur this way, but a life threatening or life taking event makes events go into fast forward and move issues from obscure to inevitable. Given EHRs many patient safety problems, this is all too likely an outcome.

ONC Initiative. ONC could step in and help right matters. For example, as I have advocated, ONC could run NIST’s usability protocols for all systems seeking MU certification. It could then publish the test results giving users a needed, common benchmark. This, in turn, could be a major push to get vendors to regard usability, etc., as an important feature.

ONC is not inclined to do this. Instead, it asks vendors to pick one of several versions of user centric technology. As Bennett Lauber, Chief Experience officer of The Usability People recently told HIEWatch:

“Usability certification for meaningful use really isn’t a test the way the rest of the certification process is. (Testers) go out and observe users, and report back to the certifiers,” Lauber reports. “There seem to be different sets of evaluation criteria because ONC has not really defined usability yet….” Emphasis Added.

Recently appointed ONC Coordinator, Dr. Karen Desalvo, unlike her predecessors, has been frank about changing ONC’s course. She’s revamped her advisory committee structure and spoken about going beyond meaningful use to big data.Notably, she understands the need for and the problems of interoperability. However, she’s not offered any changes in standards. ONC is in the best position to implement real standards, but for both political reasons; it’s unlikely to do so.

To chill things politically, vendors only have to find a few Congressmen who’ll, for a well placed contribution, will send ONC vendor drafted letters threatening its appropriation, committee reviews, etc. It can happen otherwise, but as Damon Runyon has said, “The race is not always to the swift, nor the battle to the strong, but that’s the way to bet.”

User Revolt. The most notable user push back to the status quo has involved unilateral EHR vendor agreements.

As Katie Bo Williams of Healthcare Drive (edited by Hospital EMR and EHR’s Anne Zieger) has notably described, major lawsuits are costing some vendors dearly. The industry, however, has yet to set buyer agreement standards that could aid its and EHRs’ reputation.

These lawsuits might chastise vendors, but users will need to become bolder if they want change. EHR vendors have an association to protect their interests. So do hospitals, physicians, practice managers, etc. Users are the one group that’s not represented.

You may belong to this or that product’s user group, but there is no one group that looks after EHR user’s interest. If there were a well organized and led EHR user group that lobbied for better usability, workflow tools and universal data exchange etc., then these issues would become more visible. More importantly, users would be able to demand a place at the table when ONC, etc., makes policy.

Those interested in patient safety, too, are taking some new directions. Recently, ECRI convened the Partnership for Promoting Health IT Patient Safety to promote changes, within “a non punitive environment,” that is, in a collaborative setting among vendors, practioners, safety organizations, etc. While the group has not issued any reports, it offers two hopeful signs.

The group’s advisory panel includes experts, such as, MIT’s Dr. Nancy Leveson, who works in aeronautic and ballistic missile safety systems. The other factor is that the group has consciously sought to give vendors a place where they see the impact their products have on patient safety without the threat of litigation. Whether the group can bring this off and influence the market remains to be seen.

Technical Fix. It’s possible users may decide to fix EHR’s problems themselves. For example, the University of Pittsburgh Medical Center  (UPMC) uses a combination of EPIC, Cerner and its own clinical systems. It wanted to pull patient information into one, comprehensive, easily used profile. To do this, the Center developed a new, tablet front end that overcomes a variety of common EHR problems.

Once a major actor, such as Pitt, shows there is a market, others will explore it. You’ll know it’s a real trend, when a major vendor buys a front end start up and brands it as its own.

Natural Turnover. Finally, John recently raised the question of EHRs’ future in What Software Will Replace EHR? He thinks that change will come organically as more technically robust software pushes out the old.

Slowly replacing current EHRs with new tools is the most likely path. However, a slow path may be the worst outcome. Slow turnover would give us a mixture of even more incompatible systems. This would make the XP installed base problem look simple.

The EHR brand reminds me of a politician with both high positives and negatives. It may be liked by many, however, it also has a lot of baggage. As with a candidate in that position, something will have to change those negatives or it will find itself just an also ran.

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O’Reilly Studies Health IT: The Information Technology Fix

Note: This was first published on emrandhipaa.com

O’Reilly Media specializes in books, courses and online services in technical innovation. This week, it released a new, comprehensive study on IT in Healthcare: The Information Technology Fix for Health (PDF). It’s written by O’Reilly editor Andrew Oram, who frequently writes on healthcare IT’s trends and issues. Oram takes on four basic, health IT areas in this cogent review:

  • Devices, sensors, and patient monitoring
  • Using data: records, public data sets, and research
  • Coordinated care: teams and telehealth
  • Patient empowerment

In doing so, he brings a sound knowledge of health IT current technology and issues. He also brings a rare awareness that health IT often forgets its promise to combine modern tools with an intimate doctor patient relationship:

In earlier ages of medicine, we enjoyed a personal relationship with a doctor who knew everything about us and our families—but who couldn’t actually do much for us for lack of effective treatments. Beginning with the breakthroughs in manufacturing antibiotics and the mass vaccination programs of the mid-twentieth century, medicine has become increasingly effective but increasingly impersonal. Now we have medicines and machinery that would awe earlier generations, but we rarely develop the relationships that can help us overcome chronic conditions.

Health IT can restore the balance, allowing us to make better use of treatments while creating beneficial relationships. Ideally, health IT would bring the collective intelligence of the entire medical industry into the patient/clinician relationship and inform their decisions—but would do so in such a natural way that both patient and clinician would feel like it wasn’t there. P. 4-5.

Recommended reading.

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Reply to Dr. Jacob Reider on NIST Dissects Workflow: Is Anyone Biting?

Note: This was first published on emrandehr.com

One comment on my latest post, NIST Dissects Workflow: Is Anyone Biting?, deserves a more than casual reply.

Here’s the comment from Jacob Reider (Note: Dr. Reider is ONC’s Acting Principle Deputy National Coordinator and Chief Medical Officer. He has made major contributions to the HIT field and is one of its significant advocates.)

Carl, ONC’s UCD requirement references ISO 9241–11, ISO 13407, ISO 16982, NISTIR 7741, ISO/IEC 62366 and ISO 9241–210 as appropriate UCD processes.

We also require summative testing as defined in NISTIR 7742.

Might “Refuses to incorporate NIST recommendations” be a bit of an overstatement?

We solicited public comment in our proposed rule for 2015 certification and would welcome specific suggestions for how we can/should improve user experience of health IT products for efficiency and safety.

Dr. Reider, thank you for your comment – it certainly falls into the category of you never know who’s reading.

Let’stake a look at your last comment first, “Might ‘Refuses to incorporate NIST recommendations’ be a bit of an overstatement?”

Obviously, I don’t think so, but I am not alone.

I based my comment on ONC’s statement in its rule making that refers to NIST’s usability protocols. It says:

While valid and reliable usability measurements exist, including those specified in NISTIR 7804 “Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records,” (21) we are concerned that it would be inappropriate at this juncture for ONC to seek to measure EHR technology in this way.

Sounds like a rejection to me, however, don’t take my word. Here’s the AMA’s response to this decision. First, they demur and quote ONC:

We disagree with ONC’s assertion in the Version 2014 final rule that, “[w]hile valid and reliable usability measurements exist, including those specified in NISTIR 7804 ‘‘Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records,’’ we expressed that it would be inappropriate for ONC to seek to measure EHR technology in this way.”

It then says:

To the contrary, we believe that it is incumbent upon ONC to include more robust usability criteria in the certification process.  The incentive program has certainly spurred aggressive EHR uptake but has done so through an artificial and non-traditional marketplace.  As a consumer, the physician’s choice of products is limited not only by those EHRs that are certified but also by the constraint that all of these products are driven by federal criteria.  The AMA made several detailed recommendations for improving Version 2014 certification in our Stage 2 comment letter, which were not adopted, but still hold true, and we recommend ONC consider them for the next version.  Testimony of AMA’s Health IT Policy Committee’s Workgroups on Certification/Adoption and Implementation, July 23, 2013, pp. 5-6

I recognize that ONC says that it may consider the protocols in the future. Nevertheless, I think the plain English term rejected fits.

In the first part of his statement, Dr. Reider cites several ISO standards. With the exception of the Summative Testing, all of these have been referred to, but none have been adopted. Reference to a standard is not sufficient for its inclusion under the operation of the federal Administrative Procedure Act, which governs all federal agency rulemaking. In other words, these standards are important, but ONC simply calls them out for attention, nothing more.

I think two factors are at work in ONC’s reluctance to include the NIST usability protocols. The first is that the vendors are adamantly opposed to having them mandated. However, I believe there is a way around that objection.

As I have argued before, ONC could tell vendors that their products will be subject to a TURF based review of their product for compliance and that the results would be made public. That would give users a way to judge a product for suitability to their purpose on a uniform basis. Thus, users looking at the results could determine for themselves whether or not one or more non compliance was important to them, but at least they would have a common way to look at candidate EHRs, something they cannot do now , nor under ONC’s proposed approach.

The other factor is more complex and goes to the nature of ONC’s mission. ONC is both the advocate and the standards maker for HIT. In that, it is similar to the FAA, which is vested with both promoting and regulating US aviation.

It’s well established that the FAA’s dual role is a major problem. It’s hard to be a cheerleader for an industry and make it toe the line.

With the FAA, its dual mandate is exacerbated when the highly respected NTSB investigates an incident and makes recommendations. The FAA, acting as industry friend, often defers NTSB’s authoritative and reasonable recommendations to the public’s determent.

I believe that something similar is going on with ONC. NIST’s relationship to ONC is roughly analogous to that of the NTSB’s to the FAA.

NIST is not an investigative agency, but it is the federal government’s standards and operations authority. It isn’t infallible. However, ONC dismissing NIST’s usability protocols, in one word, inappropriate. It did this without explanation or analysis (at least none that they’ve shared). In my view, that’s really inappropriate.

ONC has a problem. It’s operating the way it was intended, but that’s not what patients and practioners need. To continue the aviation analogy, ONC needs to straighten up and fly right.

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