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Two Worth Reading

HIT is a relatively small world that generates no end of notices, promotions and commentaries. You can usually skim them, pick out what’s new or different and move on. Recently, I’ve run into two articles that deserve a slow, savored reading: Politico’s Arthur Allen’s History of VistA, the VA’s homegrown EHR and Julia Adler-Milstein’s take on interoperability’s hard times.

VistA: An Old Soldier That May Just Fade Away – Maybe

The VA’s EHR is not only older than just about any other EHR, it’s older than just about any app you’ve used in the last ten years. It started when Jimmy Carter was in his first presidential year. It was a world of mainframes running TSO and 3270 terminals. Punch cards still abounded and dialup modems were rare. Even then, there were doctors and programmers who wanted to move vet’s hard copy files into a more usable, shareable form.

Arthur Allen has recounted their efforts, often clandestine, in tracking VistA’s history. It’s not only a history of one EHR and how it has fallen in and out of favor, but it’s also a history of how personal computing has grown, evolved and changed. Still a user favorite, it looks like its accumulated problems, often political as much as technical, may mean it will finally meet its end – or maybe not. In any event, Allen has written an effective, well researched piece of technological history.

Adler-Milstein: Interoperability’s Not for the Faint of Heart

Adler-Milstein, a University of Michigan Associate Professor of Health Management and Policy has two things going for her. She knows her stuff and she writes in a clear, direct prose. It’s a powerful and sadly rare combination.

In this case, she probes the seemingly simple issue of HIE interoperability or the lack thereof. She first looks at the history of EHR adoption, noting that MU1 took a pass on I/O. This was a critical error, because it:

[A]llowed EHR systems to be designed and adopted in ways that did not take HIE into account, and there were no market forces to fill the void.

When stage two with HIE came along, it meant retrofitting thousands of systems. We’ve been playing catch up, if at all, ever since.

Her major point is simple. It’s in everyone’s interest to find ways of making I/O work and that means abandoning fault finding and figuring out what can work.

Note: This was first published on: emrandehr.com

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End of the Year Loose Ends

In that random scrap heap I refer to as my memory, I’ve compiled several items not worthy of a full post, but that keep nagging me for a mention. Here are the ones that’ve surfaced:

Patient Matching. Ideally, your doc should be able to pull your records from another system like pulling cash from an ATM. The hang up is doing patient matching, which is record sharing’s last mile problem. Patients don’t have a unique identifier, which means to make sure your records are really yours your doctor’s practice has to use several cumbersome workarounds.

The 21st Century Act calls for GAO to study ONC’s approach to patient matching and determine if there’s a need for a standard set of data elements, etc. With luck, GAO will cut to the chase and address the need for a national patient ID.

fEMR. In 2014, I noted Team fEMR, which developed an open source EHR for medical teams working on short term – often crises — projects. I’m pleased to report the project and its leaders Sarah Diane Draugelis and Kevin Zurek are going strong and recently got a grant from the Pollination Project. Bravo.

What’s What. I live in DC, read the Washington Post daily etc., but if I want to know what’s up with HIT in Congress, etc., my first source is Politico’s Morning EHealth. Recommended.

Practice Fusion. Five years ago, I wrote a post that was my note to PF about why I couldn’t be one of their consultants anymore. Since then the post has garnered almost 30,000 hits and just keeps going. As pleased as I am at its longevity, I think it’s only fair to say that it’s pretty long in the tooth, so read it with that in mind.

Ancestry Health. A year ago September, I wrote about Ancestry.com’s beta site Ancestry Health. It lets families document your parents, grandparents, etc., and your medical histories, which can be quite helpful. It also promised to use your family’s depersonalized data for medical research. As an example, I set up King Agamemnon family’s tree. The site I’ve found is still in beta, which I assume means it’s not going anywhere. Too bad. It’s a thoughtful and useful idea. I also do enjoy getting their occasional “Dear Agamemnon” emails.

Jibo. I’d love to see an AI personal assistant for PCPs, etc., to bring up related information during exams, capture new data, make appointments and prepare scripts. One AI solution that looked promising was Jibo. The bad news is that it keeps missing its beta ship date. However, investors are closing in on $100 million. Stay tuned.

Note: This was first published on: emrandehr.com

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Hospitals and General Grant Have a Lot in Common

A few weeks ago, I was having a bad dream. Everything was turning black. It was hard to breath and moving was equally labored. It wasn’t a dream. I woke up and found myself working hard to inhale. Getting out of bed took determination.

I managed to get to our hallway and call my wife. She called 911 and DC’s paramedics soon had me on my way to Medstar’s Washington Hospital Center’s ER. They stabilized me and soon determined I wasn’t having a heart attack, but a heart block. That is, the nerve bundles that told my heart when to contract weren’t on the job.

A cardiology consult sent me to the Center’s Cardiac Electrophysiology Suite (EP Clinic), which specializes in arrhythmias. They ran an ECG, took a quick history and determined that the block wasn’t due to any meds, Lime disease, etc. Determining I needed a pacemaker, they made me next in line for the procedure.

Afterwards, my next stop was the cardiac surgery floor. Up till then, my care was by closely functioning teams. After that, while I certainly wasn’t neglected, it was clear I went from an acute problem to the mundane. And with that change in status, the hospital system’s attention to detail deteriorated.

This decline lead me to a simple realization. Hospitals, at least in my experience, are much like Ulysses Grant: stalwart in crisis, but hard pressed with the mundane. That is, the more critical matters became in the Civil War, the calmer and more determined was Grant. As President, however, the mundane dogged him and defied his grasp.

Here’re the muffed, mundane things I encountered in my one overnight stay:

  • Meds. I take six meds, none exotic. Despite my wife’s and my efforts, the Center’s system could not get their names or dosages straight. Compounding that, I was told not to take my own because the hospital would supply them. It couldn’t either find all of them or get straight when I took them. I took my own.
  • Food. I’d not eaten when I came in, which was good for the procedure. After it, the EP Clinic fed me a sandwich and put in food orders. Those orders quickly turned into Nothing by Mouth, which stubbornly remained despite nurses’ efforts to alter it. Lunch finally showed up, late, as I was leaving.
  • Alarm Fatigue. At three AM, I needed help doing something trivial, but necessary. I pressed the signaling button and a nurse answered who could not hear me due to a bad mike. She turned off the alert. I clicked it on again. Apparently, the nurses have to deal with false signals and have learned to ignore them. After several rounds, I stumbled to the Nurses’ Station and got help.
  • Labs. While working up my history, the EP Clinic took blood and sent for several tests. Most came back quickly, but a few headed for parts unknown. No one could find out what happened to them.
  • Discharge. The EP Clinic gave me a set of instructions. A nurse practitioner came by and gave me a somewhat different version. When we got home, my wife called the EP Clinic about the conflict and got a third version.
  • EHR. The Hospital Center is Washington’s largest hospital. My PCP is at the George Washington University’s Medical Faculty Associates. Each is highly visible and well regarded. They have several relationships. The Center was supposed to send GW my discharge data, via FAX, to my PCP. It didn’t. I scanned them in and emailed my PCP.

In last five years, I’ve had similar experiences in two other hospitals. They do great jobs dealing with immediate and pressing problems, but their systems are often asleep doing the routine.

I’ve found two major issues at work:

  • Incomplete HIT. While these hospitals have implemented EHRs, they’ve left many functions big and small on paper or on isolated devices. This creates a hybrid system with undefined or poorly defined workflows. There simply isn’t a fully functional system, rather there are several of them. This means that when the hospital staff wants to find something, first they’ll look in a computer. Failing that, they’ll scour clipboards for the elusive fact. It’s like they have a car with a five speed transmission, but only first and second gear are automatic.
  • Isolated Actors. Outside critical functions, individuals carry out tasks not teams. That is, they often act in isolation from those before or after them. This means issues are looked at only from one perspective at a time. This sets the stage for mistakes, omissions and misunderstandings. A shared task list, a common EHR function, could end this isolation.

The Hospital Center is deservedly a well regarded. It’s heart practice is its special point of pride. However, its failure to fully implement HIE is ironic. That’s because Medstar’s National Center for Human Factors in Healthcare isn’t far from the Hospital.

The problems I encountered aren’t critical, but they are troublesome and can easily lead to serious even life endangering problems. Most egregious is failure to fully implement HIT. This creates a confusing, poorly coordinated system, which may be worse than no HIT at all.

Note: This was first published on: emrandehr.com

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I’m Now a Thing on the Internet of Things

Thanks to a Biotronik Eluna 8 DR-T pacemaker that sits below my clavicle, I’m now a thing on the internet of things.biotronik-eluna What my new gizmo does, other than keeping me ticking, is collect data and send it to cell device sitting on my nightstand.

Once a day, the cell uploads my data to Biotronik’s Home Monitoring website, where my cardiologist can see what’s going on. If something needs prompt attention, the system sends alerts. Now, this is a one way system. My cardiologist can’t program my pacemaker via the net. To do that requires being near Biotronik’s Renamic inductive system. That means I can’t be hacked like Yahoo email.

The pacemaker collects and sends two kinds of data. The first set shows the unit’s functioning and tells a cardiologist how the unit is programmed and predicts its battery life, etc. The second set measures heart functioning. For example, the system generates a continuous EKG. Here’s the heart related set:

  • Atrial Burden per day 

  • Atrial Paced Rhythm (ApVs) 

  • Atrial Tachy Episodes (36 out of 48 criteria) 

  • AV-Sequences 

  • Complete Paced Rhythm (ApVp)
  • Conducted Rhythm (AsVp) 

  • Counter on AT/AF detections per day 

  • Duration of Mode Switches
  • High Ventricular Rate Counters
  • Intrinsic Rhythm (AsVs) 

  • Mode Switching
  • Number of Mode Switches 

  • Ongoing Atrial Episode Time
  • Ventricular Arrhythmia

Considering the pacemaker’s small size, the amount of information it produces is remarkable. What’s good about this system is that its data are available 24/7 on the web.

The bad news is Biotronik systems don’t directly talk to EHRs. Rather, Renamic uses EHR DataSynch, a batch system that complies with IEEE 11073-10103, a standard for implantable devices. EHR DataSynch creates an XML file and ships it along with PDFs to an EHR via a USB key or Bluetooth. However, Renamic doesn’t support LANs. When the EHR receives the file, it places the data in their requisite locations. The company also offers customized interfaces through third party vendors.

For a clinician using the website or Renamic, data access isn’t an issue. However, access can be problematic in an EHR. In that case, the Biotronik data it may or may not be kept in the same place or in the same format as other cardiology data. Also, batch files may not be transferred in a timely fashion.

Biotronik’s pacemaker, by all accounts, is an excellent unit and I certainly am glad to have it. However, within the EHR universe, it’s one more non-interoperable device. It takes good advantage of the internet for its patients and their specialists, but stops short of making its critical data readily available. In Biotronik’s defense, their XML system is agnostic, that is, it’s one that almost any EHR vendor can use. Also, the lack of a widely accepted electronic protocol for interfacing EHRs is hardly Biotronik’s fault. However, it is surprising that Biotronik does not market specific, real time interfaces for the products major EHRs.

Note: This was first published on emrandehr.com

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Is Interoperability Worth Paying For?

A member of our extended family is a nurse practitioner. Recently, we talked about her practice providing care for several homebound, older patients. She tracks their health with her employer’s proprietary EHR, which she quickly compared to a half dozen others she’s used. If you want a good, quick EHR eval, ask a nurse.

What concerned her most, beyond usability, etc., was piecing together their medical records. She didn’t have an interoperability problem, she had several of them. Most of her patients had moved from their old home to Florida leaving a mixed trail of practioners, hospitals, and clinics, etc. She has to plow through paper and electronic files to put together a working record. She worries about being blindsided by important omissions or doctors who hold onto records for fear of losing patients.

Interop Problems: Not Just Your Doc and Hospital

She is not alone. Our remarkably decentralized healthcare system generates these glitches, omissions, ironies and hang ups with amazing speed. However, when we talk about interoperability, we focus on mainly on hospital to hospital or PCP to PCP relations. Doing so, doesn’t fully cover the subject. For example, others who provide care include:

  • College Health Systems
  • Pharmacy and Lab Systems
  • Public Health Clinics
  • Travel and other Specialty Clinics
  • Urgent Care Clinics
  • Visiting Nurses
  • Walk in Clinics, etc., etc.

They may or may not pass their records back to a main provider, if there is one. When they do it’s usually by FAX making the recipient key in the data. None of this is particularly a new story. Indeed, the AHA did a study of interoperability that nails interoperability’s barriers:

Hospitals have tried to overcome interoperability barriers through the use of interfaces and HIEs but they are, at best, costly workarounds and, at worst, mechanisms that will never get the country to true interoperability. While standards are part of the solution, they are still not specified enough to make them truly work. Clearly, much work remains, including steps by the federal government to support advances in interoperability. Until that happens, patients across the country will be shortchanged from the benefits of truly connected care.

We’ve Tried Standards, We’ve Tried Matching, Now, Let’s Try Money

So, what do we do? Do we hope for some technical panacea that makes these problems seem like dial up modems? Perhaps. We could also put our hopes in the industry suddenly adopting an interop standard. Again, Perhaps.

I think the answer lies not in technology or standards, but by paying for interop successes. For a long time, I’ve mulled over a conversation I had with Chandresh Shah at John’s first conference. I’d lamented to him that buying a Coke at a Las Vegas CVS, brought up my DC buying record. Why couldn’t we have EHR systems like that? Chandresh instantly answered that CVS had an economic incentive to follow me, but my medical records didn’t. He was right. There’s no money to follow, as it were.

That leads to this question, why not redirect some MU funds and pay for interoperability? Would providers make interop, that is data exchange, CCDs, etc., work if they were paid? For example, what if we paid them $50 for their first 500 transfers and $25 for their first 500 receptions? This, of course, would need rules. I’m well aware of the human ability to game just about anything from soda machines to state lotteries.

If pay incentives were tried, they’d have to start slowly and in several different settings, but start they should. Progress, such as it is, is far too slow and isn’t getting us much of anywhere. My nurse practitioner’s patients can’t wait forever.

This post originally appeared at EMRandEHR.com.

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ONC’s Budget: A Closer Look

When HHS released ONC’s proposed FY2017 budget last winter, almost all attention focused on one part, a $22 million increase for interoperability. While the increase is notable, I think ONC’s full $82 Million budget deserves some attention.

ONC’s FY2017 Spending Plan.

Table I, summarizes ONC’s plan for Fiscal Year 2017, which runs from October 1, 2016 through September 30, 2017. The first thing to note is that ONC’s funding would change from general budget funds, known as Budget Authority or BA, to Public Health Service Evaluation funds. HHS’ Secretary may allocate up to 2.1 percent of HHS’ funds to these PHS funds. This change would not alter Congress’ funding role, but apparently signals HHS’s desire to put ONC fully in the public health sector.

Table I
ONC FY2017 Budget

fy2017-budget-justification-onc

What the ONC Budget Shows and What it Doesn’t

ONC’s budget follows the standard, federal government budget presentation format. That is, it lists, by program, how many people and how much money is allocated. In this table, each fiscal year, beginning with FY2015, shows the staffing level and then spending.

Staffing is shown in FTEs, that is, full time equivalent positions. For example, if two persons work 20 hours each, then they are equivalent to one full time person or FTE.

Spending definitions for each fiscal year is a little different. Here’s how that works:

  • FY2015 – What actually was spent or how many actually were hired
  • FY2016 – The spending and hiring Congress set for ONC for the current year.
  • FY2017 – The spending and hiring in the President’s request to Congress for next year.

If you’re looking to see how well or how poorly ONC does its planning, you won’t see it here. As with other federal and most other government budgets, you never see a comparison of plans v how they really did. For example, FY2015 was the last complete fiscal year. ONC’s budget doesn’t have a column showing its FY2015 budget and next to it, what it actually did. If it did, you could see how well or how poorly it did following its plan.

You can’t see the amount budgeted for FY2015 in ONC’s budget, except for its total budget. However, if you look at the FY2016 ONC budget, you can see what was budgeted for each of its four programs. While the budget total and the corresponding actual are identical -$60,367,000, the story at the division level is quite different.

                                   Table II
                    ONC FY2015 Budget v Actual
                                    000s

Division

FY2015 Budget $ FY2015 Actuals $ Diff
Policy Development and Coordination 12,474 13,112 638
Standards, Interoperability, and Certification 15,230 15,425 195
Adoption and Meaningful Use 11,139 10,524 (615)
Agency-wide Support 21,524 21,306 (218)
Total 60,367 60,367

 

Table II, shows this by comparing the FY2015 Enacted Budget from ONC’s FY2015 Actuals for its four major activities. While the total remained the same, it shows that there was a major shift of $638,000 from Meaningful Use to Policy. There was a lesser shift of $195,000 from Agency Support to Standards. These shifts could have been actual transfers or they could have been from under and over spending by the divisions.

Interestingly, Table III for staffing shows a different pattern. During FY2015, ONC dropped 25 FTEs, a dozen from Policy Development and the rest from Standards and Meaningful Use. That means, for example, that Policy Development had less people and more money during FY2015.

Table III
ONC FY2015
Budget v Actual Staffing FTEs
Division FY2015 Budget FTEs FY2015 Actuals FTEs Diff
Policy Development and Coordination 49 37 (12)
Standards, Interoperability, and Certification 32 26 (6)
Adoption and Meaningful Use 49 42 (7)
Agency-wide Support 55 55
Total 185 160 25

 

To try to make sense of this, I looked at the current and past year’s budgets, but to no avail. As best I can tell is ONC made great use of contracts and other non personnel services. For example, ONC spent $30 Million on purchase/contracts, which is $8 million more than it did on its payroll.

ONC’s budget, understandably, concentrates on its programs and plans. It puts little emphasis on measuring its hiring and spending abilities. It’s not alone, budgets government and otherwise, are forecast and request documents. However, if we could know how plans went – without having to dig in last year’s weeds  – it would let us know how well a program executed its plans as well as make them. That would be something worth knowing.

This post originally appeared at EMRandEHR.com.

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Dallas Children’s Health and Sickle Cell Patients: Cobbling Together a Sound Solution

Sickle cell anemia (SCA) is a genetic, red blood cell condition, which damages cell walls impeding their passage through capillaries. Episodic, it is often extremely painful. It can damage organs, cause infections, strokes or joint problems. These episodes or SCA crises can be prompted by any number of environmental or personal factors.

In the US, African Americans are most commonly susceptible to SCA, but other groups can have it as well. SCA presents a variety of management problems in the best of circumstances. As is often the case, management is made even more difficult when the patient is a child. That’s what Children’s Health of Dallas, Texas, one of the nation’s oldest and largest pediatric treatment facilities faced two years ago. Children’s Health, sixty five percent of whose patients are on Medicaid, operates a large, intensive SCA management program as the anchor institution of the NIH funded Southwestern Comprehensive Sickle Cell Center.

Children’s Health problem wasn’t with its inpatient care or with its outpatient clinics. Rather, it was keeping a child’s patents and doctors up to date on developments. Along with the SCA clinical staff, Children’s Chief Information Officer, Pamela Arora, and Information Management and Exchange Director, Katherine Lusk, tackled the problem. They came up with a solution using all off the shelf technology.

Their solution? Provide each child’s caregiver with a free Verizon smartphone. Each night, they extracted the child’s information from EPIC and sent it to Microsoft’s free, vendor neutral HealthVault PHR. This gave the child’s doctor and parents an easy ability to stay current with the child’s treatment. Notably, Children’s was able to put the solution together quickly with minimal staff and without extensive development.

That was two years ago. Since then, EPIC’s Lucy PHR has supplanted the project. However, Katherine Lusk who described the project to me is still proud of what they did. Even though the project has been replaced, it’s worth noting as an important example. It shows that not all HIE projects must be costly, time consuming or resource intense to be successful.

Children’s SCA project points out the value of these system development factors:

  • Clear, understood goal
  • Precise understanding of users and their needs
  • Small focused team
  • Searching for off the shelf solutions
  • Staying focused and preventing scope creep

Each of these proved critical to Children’s success. Not every project lends itself to this approach, but Children’s experience is worth keeping in mind as a useful and repeatable model of meeting an immediate need with a simple, direct approach.

[Note: I first heard of Children’s project at John’s Atlanta conference. ONC’s Peter Ashkenaz mentioned it as a notable project that had not gained media attention. I owe him a thanks for pointing me to Katherine Lusk.]

This post originally appeared at EMRandEHR.com.

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Dumb Question 101: What’s Workflow Doing in an EHR?

This was going to be a five year relook at Practice Fusion. Back then, I’d written a critical review saying I wouldn’t be a PF consultant. Going over PF now, I found it greatly changed. For example, I criticized it s not having a shared task list. Now, it does. Starting to trace other functions, a question suddenly hit me. Why did I think an EHR should have a shared task list or any other workflow function for that matter?

It’s a given that an EHR is supposed to record and retrieve a patient’s medical data. Indeed, if you search for the definition of an EHR, you’ll find just that. For example, Wikipedia defines it this way:

An electronic health record (EHR), or electronic medical record (EMR), refers to the systematized collection of patient and population electronically-stored health information in a digital format.[1] These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.[2]

Other definitions, such as HIMSS are similar, but add another critical element, workflow:

The EHR automates and streamlines the clinician’s workflow.

Is this a good or even desirable thing? Now, before Chuck Webster shoots out my porch lights, that doesn’t mean I’m anti workflow. However, I do ask what are workflow features doing in an EHR?

In EHRs early days, vendors realized they couldn’t drop one in a practice like a fax machine. EHRs were disruptive and not always in a good way. They often didn’t play well with practice management systems or the hodgepodge of forms, charts and lists they were replacing.

As a result, vendors started doing the workflow archeology and devising new ones as part of their installs. Over time, EHRs vendors started touting how they could reform not just replace an old system.

Hospitals were a little different. Most had IT staff that could shoehorn a new system into their environment. However, as troubled hospital EHR rollouts attest, they rarely anticipated the changes that EHRs would bring about.

Adding workflow functions to an EHR may have caused what my late brother called a “far away” result. That is, the farther away you were from something, the better it looked. With EHR workflow tools, the closer you get to their use, the more problems you may find.

EHRs are designed for end users. Adding workflow tools to these assumes that the users understand workflow dynamics and can use them accordingly. Sometimes this works well, but just as often the functions may not be a versatile as the situation warrants. Just ask the resident who can’t find the option they really need.

I think the answer to EHR workflow functions is this. They can be nice to have, like a car’s backup camera. However, having one doesn’t make you a good driver. Having workflow functions shouldn’t fool you into thinking that’s all workflow requires.

The only way to determine what’s needed is by doing a thorough, requirements analysis, working closely with users and developing the necessary workflow systems.

A better approach would be a workflow system that embeds its features in an EHR. That way, the EHR could fit more seamlessly its environment, rather than the other way around.

This post originally appeared at EMRandEHR.com.

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Finding an EHR With On Line Tools

So, you want to dump your EHR and find another, or about to join the fray? Once you’ve got a handle on your requirements, this review lists some online tools that might help. Ideally, they’ll point to the one that’s best for you. Even if they can’t do that, they should help identify what you don’t want. Along the way, they may also raise some new issues, or give you some new insights.

Full Disclosure: I manage EHRSelector.com, but it’s not included.

Finding EHR Tools

The web has a surfeit of EHR evaluation tools. I’ve only reviewed those that are vendor independent and employ some filtering or ranking. That excludes spreadsheets and PDFs that just list features. I also skipped any that charge. I found the nine shown in Table I and reviewed below. Table II explains my definitions.

EHR Tool Table IEHR Tool Table II
EHR Tools Reviewed

1. American EHR. American’s tool gives you several ways to look at an EHR. Its side by side list compares 80 features. It asks users to rank a dozen features on a 1 to 5 scale. To use the tool, you pick a practice size and specialty. You can also see how users rated a product in detail, which shows how it stacks up against all its others. Unfortunately, its interface is a hit or miss affair. When you change a product choice sometimes it works and sometimes it just sits there.

2. Capterra. Capterra ranks the top 20 most popular EHRs, or at least the most well known. To do this, it adds up the number of customers, users and social media scores. That is, how often they’re mentioned on Twitter, Facebook, etc. Users rank products on a 1 to 5 scale and can add comments. It has a basic product filtering system.

3. Consumer Affairs. It examines ten major vendors using a short breakdown of features and user reviews. Users rate products on a 1 to 5 scale and can add comments.

4. EHR Compare. This tool solely relies on user ratings. Users score 20 EHR features on a 1 to 5 scale. It may add additional features depending on specialty. It only has a handful of reviews, which is a drawback.

5. EHR in Practice. EHR in Practice provides a short list of features and thumbnail EHR descriptions.

6. EHR Softwareinsider. This site uses ONC attestations to rank vendors. Its analysis shows those rankings along with Black Book ratings. Users rank products on a 1 to 10 scale. Interestingly, users can earn a $10 Amazon gift card for their reviews. For a fee, a vendor can move their product to the top of a list, though ES says that does not influence other factors.

7. Select Hub. There is one big if to using this site, if you can get in. As with some sites, SH requires that you register to get to its rankings. The problem is that once you do, you may wait for a day or more for a confirming email link. Even then, it didn’t see the confirmation, so I had to repeat, etc. If you get in, you’ll find some interesting features. Its staff briefly analyzes a product’s performance for each function. The other is that you can set up a project for yourself and others to query vendors.

8. Software Advice. Software Advice is a user rating site based on a 1 to 5 scale. It offers filters by rating rank, specialty and practice size as well as a short product summary.

9. Top Ten Reviews. As the name implies, Top Ten shows just that. There are two problems with its rankings. It doesn’t explain how it chose them or how they are ranked. It provides a thumbnail for each product.

What to Use. Several of the EHR comparison are just popularity contests. They have limited filters and depend on user reviews from whoever walks in the door. Two, however, go beyond that and are worth exploring: American EHR and Select Hub. Both have interface problems, but with persistence, you can find out more about a product than using the others.

With that said, you may also may find it useful to go through the user ranked tools. They may help you cull out particular products or interest you in one you’ve overlooked. Finally, if I’ve left something out, please let me know. I’ll add it in a revised post.

This post originally appeared at EMRandEHR.com.

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Could a Virtual Scribe Solve EHR Usability Problems?

Jibo: A Home Robot Promises a New Level of AI Use

Dr. Cynthia Breazeal

Dr. Cynthia Breazeal

I ran across a new, five pound, home robot called Jibo in an IEEE publication my wife gets. Jibo, whose first planned product run has sold out at $750 each, promises to ship this Spring. It bills itself as the first social robot.

Started as an INDIGOGO project that banked close to $4 million, Jibo recently added $36 million from investors.  Its technology smarts come from its founder, chief scientist and MIT Associate Professor, Dr. Cynthia Breazeal.
Jibo’s driven by an ambition to bring artificial intelligence capabilities to the home market. Though it’s not mobile, it’s touch sensitive, gesture sensing and can dip and swivel 360 degrees to capture events. Jibo’s natural language processing uses two high res cameras to recognize faces, do your selfies and run video calls.

With these capabilities, Jibo is far smarter than smart thermometers, vacuum cleaners or security systems. It’ll use these to learn your phrases and gestures, so it can act as your calendar, inbox, media organizer and general personal assistant. Importantly, Jibo has a significant, developer program. That’s what gave me the idea for a virtual scribe.

An EHR Virtual Scribe?

High end EHRs have been using natural language processing for years. You dictate and the system figures out what and where to put the text. These pricey add-ons aren’t widely used.

Less versatile, but far more used is Dragon Voice. Other smart assists are various macro systems and front ends. These improve an often frustrating, mind numbing EHR interface, but are only a partial solution. Their major disadvantage is that the user is tethered to a machine. Ideally, a doctor should be able to talk with their patient, and seamlessly use the record as needed.

If new, smart devices such as Jibo really can aid around the house, it should be possible in another generation or so, to free practioners from their tablets or keyboards. An EHR virtual scribe with cameras and projector could do these tasks:

  • Workflow. Set up workflow based on patient history and appointment type.
  • Encounter Record. Record doctor-patient audio and video unobtrusively.
  • History. Project the patient’s history and labs, etc., as requested.
  • Updates. As the user dictates, the scribe could show the entries to both.
  • Assessment. As the user builds the note, the scribe could show how it compares to similar cases or when asked do searches.
  • Plan. The scribe could produce potential plans and let the user modify them.
  • Orders. Based on the plan, past orders, etc., it could propose new orders.
  • Education. Provide tailored materials, references, etc.
  • Appointment. Set up appropriate follow on appointments.
  • Claims. Interface with claiming and reporting systems as needed.

Products such a Jibo hold the potential for a technical fix for EHRs seemingly intractable usability problems and do it at reasonable cost. Their combination of adaptable hardware, AI abilities and unobtrusive size may just be the ticket.

This post originally appeared at EMRandEHR.com

Carl Bergman
Managing Partner
carl@ehrselector.com

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AncestryHealth: A Family Medical Conditions Tree

Ancestry.com, the genealogy behemoth, has entered the health field — sort of. AncestryHealth (AH), a beta foray, helps you document your family’s medical conditions. To start, you build a family tree of your blood relations. Unlike a typical family tree, it only lists those who’re your biological relations. So, your spouse is out, but your kids are in. However, your grandchildren, for some reason, aren’t tracked.

AH Home Page

AncestryHealth Home Page

To show how AH works, I built a tree for King Agamemnon and his family. At top of the Agamemnon’s chart are his four grandparents, Pelops, etc. Below them are his parents. On Agamemnon’s level is his brother Menelaus, whose wife caused some marital stress.

The Agmemnom's Family Tree

The Agamemnon’s Family Tree

Chart Building. AH’s heart is its family member entry screens. First, you add the member, for example, a daughter then her conditions. You could also build the chart and then enter conditions.

Adding a person’s health conditions is a simple, top down process. When you select someone, AH brings up its basic conditions menu. It has five general categories: Heart, Cancer, Lung, Brain or Metabolism. If those don’t make it, a click brings up 13 more: Muscle, Autoimmune, etc., or you can add your own. Unlike EHRs, etc., AH is strictly for recording health conditions not their treatments. You can note, for example, your mother’s osteoarthritis, but not what she takes for it. 

AH Conditions

Adding Family Conditions

When you’ve picked general categories, you can leave it at that. For example, if you knew Aunt Agatha had allergies, but not much more about her, you’d be done. You can add as many general categories as you like to any one person.

To add more detail, you select the person and then you can add both medical and lifestyle details. Again, you can use AH’s choices or add your own.

Detailed Conditons

Detailed Conditions

When you’re done, you use the family tree to see everyone or just those with a specific condition. For example, you’d see the relationship, if any, of everyone who has or had heart disease. Finally, you can download a summary of all your family’s conditions.

Daughter Entry Screen

Daughter Entry Screen

As with any beta program, some of AH parts are less finely developed than others. Many of the problems were with the member entry screen. For example, if a person has two first names, such as, Mary Beth she’ll show up as Mary.

Daughter Detail Screen

Daughter Detail Screen

Once the member’s on the chart, you have to edit their entry to add a last name and living status. I don’t know why this isn’t done with a single entry screen instead of two screens.

If you do add a last name, it doesn’t show on the tree. That means if you have two Great Uncle Davids, you’ll have to open the record to make sure you have the right one. It would also be helpful if the member screen had an Unknown Name box.

Similar to Facebook, you can’t use titles, such as Dr., Ms., etc. However, if you leave out the period, it’s accepted. Nor can you add, MD, PhD, etc., unless you omit the comma after their last name.

Lost Child. AH gives you both an on screen graphic and a printed health summary. The graphic lets you click on a person’s icon – though their names don’t show – and see the detail.

In one case, Electra’s icon disappeared. Given the family’s way of settling their issues, I wasn’t too surprised.

Children Etc

AH’s Big Sibling Connection

If you have an Ancestry account, you can use it to log into AH. You can also create one for AH. When you create a new AH account, one is also opened for you in Ancestry.com, whether you want it or not. For example, using a Gmail address I created the Agamemnon family tree. That login is now part of Ancestry.com. I can’t think of a system that opens an account for you in another system.

If you do use your Ancestry.com account for AH, any change you make in your AH family tree changes your Ancestry.com tree as well. You can avoid this if you make a private copy of your Ancestry.com tree. AH should offer to do this without your going to Ancestry.com, etc.

That’s not the end of it. When I needed to change the spelling for one of the persons on my AH chart, I found all entries were locked. I could only change someone’s conditions, or add a new person. However, I could not edit anyone’s name, etc., nor could I remove someone. To edit, I had to go to Ancestry.com’s Agamemnon family tree, which has a far different interface. Apparently, this occurs if you’re logged into the same Ancestry.com site. Wading through all of this was like trying to figure out Abbot and Costello’s Who’s on First, but not as much fun.

Sorta Informed Consent. AH shares your family conditions, less any personally identifiable information, with health researchers, etc. I don’t object to their doing that and it has significant potential. AH posts a long Informed Consent note about their sharing family information. However, AH puts this where it’s unlikely to be read. It’s a link at the bottom of each page along with Terms and Conditions, etc. Given its importance, it deserves higher billing.

It is a Beta. AH is a work in progress by the major, family genealogical site. During its beta, AH is free and AH is interested in its reception. It wants comments on adding functions, such as, AncestryDNA data, or risk analysis tools. Its family condition documentation may prove quite valuable to you and possibly to medical researchers.

AH’s Family Condition

AH needs to fix several design flaws and eliminate some obvious bugs. It needs to do a far better job of letting you know what it does with your data. Most importantly, it needs to sort out and clear up its various, functional relationships with Ancestry.com. You might call it an Ancestry family condition.

This post originally appeared at EMRandEHR.com

Carl Bergman
Managing Partner
carl@ehrselector.com

 

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About That Doctor – Patient-EHR Relationship

Note: This originally was posted to: EMRandEHR.com

My friend Joe is a retired astrophysicist turned web geek. Joe’s had his health problems, but he’s still an avid bicycle rider as well as one of the most well read persons I’ve ever known. He doesn’t miss much, and always has his own – often original – take on politics, the economy, the net and a lot else.

There is one topic where his take echoes many others. He never fails to send me posts about how EHRs interfere in the doctor – patient relationship. He just loathes it when his doc spends time keying away rather than making eye contact.

Joe knows I get pretty wound up on EHR usability and interop problems, but that just makes me an even better target for his disgruntlement. He, of course, has a point as do so many others who’ve lamented that what was once a two way conversation has become a three way with the patient the loser.

The point, I think, only goes so far. What’s going on in these encounters is more than the introduction of an attention sucking PC. It’s simply wrong to assume that medical encounters were all done the same warm and fuzzy way until EHRs came along. To understand EHRs effect from a patient’s perspective, I think we need to ask ourselves several questions about our EHR involved medical appointments.

Many of the changes have been disruptive in the old sense of that word. Asking yourself these questions may help assuage some of the feelings of loss and put the EHRs’ use in better perspective:

  • Whose Appointment Is It? Are you there alone, with an elderly parent, your spouse or your child, etc.?
  • Appointment’s Purpose. Why are you there? Is it for a physical, is it due to bad cold, a routine follow up or is it for a perplexing question? Is it with a specialist, pre or post op?
  • Your Relationship. How long and how well have you know this doctor? How many doctors have you had in the past few years?
  • How Long Has It Been? When was the last time you saw your doctor, days, weeks, years? How much catching up is there to do?
  • Doc’s Actions. What’s your doc doing on the EHR, looking for labs, going over your meds, writing notes, writing prescriptions, ordering tests, checking drug interactions? How many of these would have been impossible or difficult on paper?
  • Money. How much time does your doc take trying to save you money finding generics, looking at what your insurance covers, etc.?

Many EHRs have usability problems and many have been implemented poorly. As with all technological innovations in professional settings though, they often create longing for the good old days, which may never had existed. We need to remember that medical records could not continue to exist as paper records written more as reminders than searchable, definitive records.

EHRs have changed provider’s roles. They have to create records not just for themselves, their partners, etc., but also for other providers and analysts they may never meet. As patients, we also need to understand that EHRs, like word processing, cell phones, and the internet itself are far from perfect. Banishing them may allow more personal time for you, but what will it mean for your care, your doctor or for the next patient?

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Warm, Fuzzy EHR Selection Website Looking for a New Best Friend

Note: This orignially was posted to: EMRandEHR.com

After 15 years running the EHRSelector, a free, interactive app for finding an EHR, my partner, Cali Samuels and I want to sell or give it to someone who can help it meet its potential.

What’s the Selector?

The Selector’s idea is simple: Give those looking for an EHR an objective way to find a new EHR that centers on what it can do.

Here’s how it works. You go down an extensive EHR feature list. As you click what you want, it instantly shows which products match. You can then compare them like this: EHR Selector Side by Side.

Here’re its major categories. Each has a clickable feature list. For example, you can choose among 50 medical specialties. We also show which features are HIPAA or MU required.

EHRSelector Major Categories

What’s the Problem?

So, why do we want to sell it or give it away? Simple, we can’t crack two problems. Vendors don’t update their profiles and, consequently, there’s low user interest.

The selector depends on vendors subscribing to it and keeping their product lists up to date. Even though it’s free, we can’t convince vendors to update their information.

We’ve written and called, but we run into several problems. Often it’s impossible to get through to a person. When we do, we get bounced among sales, marketing and technical types. Contacts who we’ve dealt with are often gone and no one knows who can speak to all product features.

Then there’s the connected question of driving users to the site. If our vendor list isn’t up to date, we can’t expect a high user volume. As it is, we get some users who understand that while not everything is current, few EHRs take out features. Occasionally, whole college classes sign up. We’re pleased to serve them, but that rarely interests vendors.

How Does It Make Money?

It doesn’t. For several years, we ran the selector on a subscription basis for both users and vendors. This paid for hosting and maintenance, but the marketing firm that ran it lost interest and it began to lose subscribers.

Two years ago, my partner and I took it back, put on a new home page, added a blog and made it free for everyone. We hoped to get enough traffic to sell ads. That hasn’t worked out. We get a few hundred hits a week, but we don’t have the user or vendor interest to justify ads.

What Are We Looking For?

We would like to turn the site over to someone who shares our interest in an objective, interactive EHR selection tool. Obviously, we want someone who has the marketing clout to get vendors interested.

The Selector’s written in classic ASP. It’s functions work, but it could stand a good rewrite making it more intuitive and less 2001. Finally, we’d love to add a mobile app, user ratings and graphics comparing products.

Sell or Buy?

Cali and I have enough cash and sweat equity in the selector to build a Tesla. It’s never paid, but we’ve been content to run it break even or even at a loss, because we believe it’s an important service.

We’d love someone to dump goo gobs of dough on us for it, modernize it, etc., – are you listening Google? However, we’re realistic enough to look for someone who shares our interest in giving users a useful EHR tool finding tool and who has the wherewithal to carry it on. You can reach me at: carl@ehrselector.com

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Where the Jobs Are – 2015 Update: Demand for EHR/HIT Certifications

Note: This was originally posted on EMRandEHR.com

One year ago, I looked at the demand for EHR related certifications. I found, as the old line goes, that many are called but few are chosen. Of 30 or so certificate programs, only about a quarter had substantial demand. In fact, 1 had no demand.

Study Update

Finding Certification Programs. To bring the study up to date, I looked for new certificates or ones I’d overlooked. I found one, CEHRS, Certified Electronic Health Record Specialist Certification from the National Healthcareer Association.

Searching for Jobs. As with last year’s study, I then used John’s HealthcareITCentral to search for jobs posted in the last 30 days that require an EHR or HIT certification.

Certifications Reviewed

Table I lists the 12 certifications, which had at least one job opening. Last year, I found at least 16 certifications with at least one opening. That is, this year as shown in Table II, I found no mentions for 15 certificates.

Table I
Certifications In Demand
1 CCA 7 CHTS
2 CCS 8 CICP
3 CCS-P 9 CompTIA
4 CHDA 10 CPHIMS
5 CHPS 11 RHIA
6 CHSP 12 RHIT

Table II, lists the 12 certifications that had no openings in the last 30 days.

Table II
Certifications Without Demand
1 CAHIMS 9 CPCIP
2 CEHRS 10 CPORA
3 CEOP 11 CPHP
4 CHTP 12 CPORA
5 CEMP 13 HWCP
6 CHTSP 14 CPEHR
7 CIPCP 15 CPHIT
8 CMUP    

Review Caveats

What Counts. Each certification listed in a job counts as one opening. For example, if a job listed ComTIA, CPHIMS and CPEHR, I counted it as three jobs, one for each certification.

General certifications only. For practical reasons, this review only covers general certifications that have a one word abbreviation. Where the abbreviation isn’t unique, I’ve filtered out non certificate uses.

No EDUs. I excluded certificates from colleges, universities, etc., whether traditional or on line. There are scads of these, but I’m not aware of any that are in general demand. That’s not a judgment on their value, just their demand.

Vendor Certifications I excluded product specific certifications, for example, NexGen Certified Professional.

Dynamics. The openings for these certifications are a snapshot. The job market and the openings that HealthcareITCentral lists constantly change. What is true now, could change in a moment. However, I believe it gives you a good idea of relative demand.

Certification Demand

In the past 30 days, I found 322 openings that listed a certification. See Chart I. As with last year, AHIMA’s were most in demand. Two of its certificate programs, RHIA and RHIT account for 60 percent of certificate demand.

Chart I Certification Openings

RHIA’s designed to show a range of managerial skills, rather than in depth technical ability. If you consider certifications proof of technical acumen, then the strong RHIA demand is a bit counter intuitive. Where the RHIA has a broad scope, the close second, RHIT, is more narrowly focused on EHRs.

In third place, but still with a substantial demand is CCS, which focuses on a specific ability. Compared to last year, CCS has fewer openings. This is due to a change in my methodology not demand. Last year, I counted any CCS opening. This year, I only count those with a clear HIT relationship.

Certification Location Demand

After looking at certification demand, I looked at it by state. To do this, I merged the different certification job openings into a single list. That is, I added those for RHIA, RHIT, etc., and then eliminated duplicates.

After creating a consolidated list, I sorted and subtotaled by state. I then sorted the state totals. This gave me the data for Chart II. It shows the top ten states for openings, including/ two ties.

Chart II State Demand

State Rankings. As you might expect, states with the largest populations have the most jobs. California leads, which is what you’d expect.

To account for population, I take job rank from population rank. For example, Washington State is 13th in population. It’s eight in job openings. So, subtracting job rank eight from population rank 13 is five. That is, Washington State’s job share is five ranks above its population ranking. Chart III shows the result where states stand when you account for population.

Chart III Rank Adjusted for Population

Most notable is Colorado. Colorado is 22nd in population, but fifth in certification demand. That is job openings for it are 17 ranks higher than population would account for.

Others ranking higher than their population are: Missouri, Arizona, Tennessee, Wisconsin, etc. Conversely, those states, which have openings below their rank, include New York, Pennsylvania and Florida.

Missouri’s case is interesting. Almost all its openings are from one company: Altegra. Its openings are almost all for one position type: medical record field reviewer. At first, I thought this was a case of over posting, but it doesn’t appear to be. They’re recruiting for several different locations.

Certification Demand Trends

When I stated this update, I expected there would be more jobs due to economic growth, but that hasn’t happened. There’ve been shifts among states, but overall the demand is pretty much the same. RHIA and RHIT demand last year and this year are practically identical while demand for others has dropped. I don’t have any numbers for overall openings then and now, but I suspect that they’ve grown while certification demand has either gone down or been flat. However, as I’ve said that’s just a guess.

Certifications are a response to the demand for persons with demonstrated skills. The question is whether a one will reward your time, cost and effort with something that is marketable. Demand alone can’t make that choice for you. For example, working on a certificate that has little or no demand might seem pointless. However, its requirements may be a good way for you to acquire demonstrate your skills, especially if your experience is iffy.

Personal satisfaction also can’t be discounted as a factor. You might be interested in an area with low demand, but when coupled with your other skills might make you marketable in an area you desire.

If you do decide to pursue one of these certificates, I think these numbers can help you know where to look and what to look for.

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Restructure and Reform Meaningful Use: Here’s a Way

Note: This was originally posted on EMRandEHR.com

It’s no secret that ONC’s meaningful use program’s a mess. I’m not sure there is an easy way out. In some respects, I wish they would go back and start over, but that’s not going to happen. They could do something to see daylight, but it won’t be either easy or simple. As I‘ll outline, ONC could adopt a graduated system that keeps the MU standards, includes terribly needed interoperability and usability standards, but does not drive everyone crazy over compliance.

MU’s Misguided Approach

ONC has spent much time and money on the MU standards, but has painted itself into a corner. No one, vendors, practioners or users is happy. Vendors see ONC pushing them to add features that aren’t needed or wanted. Practioners see MU imposing costs and practices that don’t benefit them or their patients. Users see EHRs as demonic Rube Goldberg creations out to frustrate, confuse and perplex. To boot, ONC keeps expanding its reach to new areas without progress on the basics.

Most the MU criticisms I’ve seen say MU’s standards are too strict or too vague. Compliance is criticized for being too demanding or not relevant. Most suggested cures tinker with the program: Eliminate standards or delay them. I think the problems are both content and structure. What MU needs is a return to basics and a general restructuring.

Roots of the MU Program’s Problems

It’s easy to beat up on ONC’s failures. Almost everyone has a pet, so I’ll keep mine short.

MU1: Missed Opportunities. MU’s problems stem from its first days. ONC saw EHRs as little more than database systems that stored and retrieved encounters. Data sharing only this:

Capability to exchange key clinical information (for example, problem list, medication list, medication allergies, diagnostic test results), among providers of care and patient authorized entities electronically.

Compliance only required one data exchange attempt. ONC relied on state systems to achieve interoperability. Usability didn’t exist.

MU2: Punting the Problems. ONC’s approach to interoperability and usability was simple. Interoperability was synonymous with continuity of care and public health reports. Every thing else was put off for future testing criteria.

ONC’s usability approach was equally simple. Vendors defined their usability and measurement. The result? Usability’s become a dead topic.

Interoperability

ONC has many good things to say about the need for interoperability. Its recent Roadmap is thoughtful and carefully crafted. However, the roadmap points out just how poor a job ONC has done to date and it highlights, to me, how much ONC needs to rethink its entire MU approach.

Changing ONC

In one of his seminal works on organizations, C. Northcote Parkinson said it’s almost impossible to change a failing organization. His advice is to walk away and sew salt. If you must persist, then you should adopt the heart of a British Drill Sergeant, that nothing is acceptable. Alas, only Congress can do the former and I’m way too old for military service, so I will venture on knowing it’s probably foolhardy, but here goes.

New Basic Requirements

A better approach to MU’s core and menu system would allow vendors to pick and choose the features they want to support, but require that all EHRs meet four basic standards:

  1. Data Set. This first standard would spell out in a basic, medical data set. This would include, for example, vitals, demographics, meds, chief complaints, allergies, surgeries, etc.
  2. Patient ID. A patient’s demographics would include a unique patient identifier. ONC can use its new freedom in this area by asking NIST to develop a protocol with stakeholders.
  3. Interoperability. EHRs would have to transmit and receive, on demand, the basic data set using a standard protocol, for example, HL7.
  4. Usability. Vendors would have to publish the results of running their EHR against NIST’s usability standard. This would give users, for the first time, an independent way to compare EHRs’ usability.

All current EHRs would have to meet these criteria within one year. Compliance would mean certification, but EHRs that only met these criteria would not be eligible for any funding.

Cafeteria Program. For funding, vendors would have to show their EHR supported selected MU2 and MU3 features. The more features certified, the more eligible they’d be for funding.

Here is how it would work. Each MU criteria would have a one to ten score. To be eligible for funding, a product would have to score 50 or more. The higher their score, the higher their funding eligibility.

Provider Compliance. Providers would have a similar system. ONC would assign scores of one to ten for each utilization standard. As with vendors, implementing organizations would receive points for each higher utilization level. That is, unlike current practice, which is all or nothing, the more the system is used to promote MU’s goals the higher the payments. This would permit users to decide which compliance criteria they wanted to support and which they did not.

Flexibility’s Advantages

This system’s flexibility has several advantages. It ends the rigid nature of compliance. It allows ONC to add new criteria as it sees fit giving it freedom to add criteria as needed or to push the field.

It achieves a major advancement for users. It not only tells users how products perform, but it also lets them choose those that best fit their needs.

Vendors, too, benefit from this approach. They would not only know where they stood vs. the competition, but would also be free to innovate without having to include features they don’t want.

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The New Congressional Rider: Patient ID Lemonade?

Note: This was originally posted on EMRandEHR.com

Also: Previous versions referred to Rand Paul as the author of the first congressional rider. That was in error. The first rider was authored by then Representative Ron Paul. I regret the error. CB

Last month, I posted that Ron Paul’s gag rule on a national patient identifier was gone. Shortly, thereafter, Brian Ahier noted that the gag rule wasn’t dead. It just used different words. Now, it looks as if we were both right and both wrong. Here’s why. Paul’s rider’s gone, but its replacement, though daunting, isn’t as restrictive.

The gag rules are appropriation bill riders. Paul’s, which began in 1998, was aimed at a HIPAA provision, which called for identifiers for:

…. [E]ach individual, employer, health plan, and health care provider for use in the health care system. 42 US Code Sec. 1320d-2(b)

It prohibited “[P]lanning, testing, piloting, or developing a national identification card.” This was interpreted to prohibit a national patient id.

As I noted in my post, Paul’s language was dropped from the CRomnibus appropriation act. Brian, however, found new, restrictive language in CRomnibus, which says:

Sec. 510. None of the funds made available in this Act may be used to promulgate or adopt any final standard under section 1173(b) of the Social Security Act providing for, or providing for the assignment of, a unique health identifier for an individual (except in an individual’s capacity as an employer or a health care provider), until legislation is enacted specifically approving the standard.

Gag Rule’s Replacement Language

Unlike Paul’s absolutist text, the new rider makes Congress the last, biggest step in a formal ID process. The new language lets ID development go ahead, but if HHS wants to adopt a standard, Congress must approve it.

This change creates two potential adoption paths. Along the first, and most obvious, HHS develops a mandatory, national patient ID through Medicare, or the Meaningful Use program, etc., and asks congress’ approval. This would be a long, hard, uphill fight.

The second is voluntary adoption. For example, NIST could develop a voluntary, industry standard. Until now, Paul’s rider stopped this approach.

NIST’s a Consensus Building Not a Rulemaking Agency

NIST’s potential ID role is well within its non regulatory, consensus standards development mandate. It could lead a patient ID building effort with EHR stakeholders. Given the high cost of current patient matching techniques, stakeholders may well welcome a uniform, voluntary standard. That would not solve all interoperability problems, but it would go a long way toward that end.

Congress has loosened its grip on a patient ID, now its up to ONC, NIST, etc., to use this new freedom.

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Congress Getting Real About Interoperability Kills Paul Gag Rule

Note: This was originally posted on EMRandEHR.com

Correction: Brian Ahier looked at this post and made a better search through the legislation. When I searched, I used the same words that had been in use since 1998, which mentioned HIPAA and a national ID. As you can see in his post, the new language does not. I did not use the health ID language. I apologize for the error and thank him for his correction.

Sometimes what Congress leaves out is as important as what it puts in. The CRomnibus Act has an example for HIT. In its hundreds of pages, Congress took three actions to promote HIT interoperability. Two have been widely reported: It ordered ONC to report on interoperability data blocking and to spell out other impediments.

The third action, which I haven’t seen reported, was an omission. Ron Paul’s patient ID gag rule is no more.

In 2000, then Representative Paul (R-TX) put a rider on HHS’ appropriation blocking HIPAA’s call for a unique, patient ID. It prohibited, “planning, testing, piloting, or developing a national identification card.” Given Paul’s statements, this meant no patient ID development. By making it impossible to even think about an ID, ONC could not assess the full range of interoperability options.

Each spending bill since 2000 has had the rider, until now. Noting remotely similar is in the bill. I’m still trying to find out who and when dropped this.

What’s clear, though, is that Congress is serious about interoperability and has given ONC a clear field to develop a real plan. A bad gag rule is gone.

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Adverse Event Reporting and EHRs: The MEDTECH Act’s Effects

Note: This was originally posted on: EMRandEHR.com

EHRs and Adverse Events

Medical systems generate adverse event (AE) reports to improve service delivery and public safety.

As I described in this note’s first part, these reports are both a record of what went wrong and a rich source for improving workflow, process and policy. They can nail responsibility not only for bad acts, but also bad actors and can help distinguish between the two. The FDA gathers AE reports to look for important health related patterns, and if needed to trigger recalls, modifications and public alerts.

EHRs generate AEs, but the FDA doesn’t require reporting them. Reporting is only for medical devices defined by the FDA and EHRs aren’t. However, users sometimes report EHR related AEs. Now, there’s proposed legislation that would preclude EHRs as medical devices and stop any consideration of EHR reports.

MEDTECH Act’s Impact

EHRs are benign software systems that need minimal oversight. At least that’s what MEDTECH Act’s congressional sponsors, Senators Orrin Hatch (R- Utah) and Michael Bennett (D- Colorado) think. If they have their way – and much of the EHR industry hopes so – the FDA can forget regulating EHRs and tracking any EHR related AEs.

EHRs and Adverse Events

Currently, if you ask MAUD, the FDA’s device, adverse event tracking system about EHRs, you don’t get much, as you might expect. Up to October, MAUD has 320,000 AEs. Of these about 30 mention an EHR in passing. (There may be many more, but you can’t search for phrases such as “electronic health,” etc.) While the FDA hasn’t defined EHRs as a device, vendors are afraid it may. Their fear is based on this part of the FDA’s device definition standard:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

…[I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…

I think this section clearly covers EHRs. They are intended for diagnostic, cure, mitigation, etc., of disease. Consistent public policy in general and a regard for protecting the public’s health, I think, augers for mandatory reporting of EHR caused AEs.

Why then aren’t EHRs devices that require AE reporting? In a word, politics. The FDA’s been under pressure from vendors who contend their products aren’t devices just software. They also don’t want their products subject to being criticized for failures, especially in instances where they have no control over the process. That may be understandable from a corporate point of view, but there are several reasons for rejecting that point of view. Consider what the FDA currently defines as a medical device.

Other Devices. The FDA captures AE reports on an incredible number of devices. A few examples:

  • Blood pressure computers
  • Crutches
  • Drug dose calculators
  • Ice bags
  • Lab gear – practically all
  • Robotic telemedicine devices, and many, many more.

ECRI on EHR Adverse Events

The respected patient safety NGO, the ECRI Institute, puts the issue squarely. Each year, it publishes its Top Ten Health Technology Hazards. Number one is inadequate alarm configuration policies and practices. Number two: “Incorrect or missing data in electronic health records and other health IT systems.” Its report says:

Many care decisions today are based on data in an electronic health record (EHR) or other IT-based system. When functioning well, these systems provide the information clinicians need for making appropriate treatment decisions. When faults or errors exist, however, incomplete, inaccurate, or out-of-date information can end up in a patient’s record, potentially leading to incorrect treatment decisions and patient harm. What makes this problem so troubling is that the integrity of the data in health IT (HIT) systems can be compromised in a number of ways, and once errors are introduced, they can be difficult to spot and correct. Examples of data integrity failures include the following:

  • Appearance of one patient’s data in another patient’s record (i.e., a patient/data mismatch)
  • Missing data or delayed data delivery (e.g., because of network limitations, configuration errors, or data entry delays)
  • Clock synchronization errors between different medical devices and systems
  • Default values being used by mistake, or fields being prepopulated with erroneous data
  • Inconsistencies in patient information when both paper and electronic records are used
  • Outdated information being copied and pasted into a new report Programs for reporting and reviewing HIT-related problems can help organizations identify and rectify breakdowns and failures.

ECRI spells out why AE reporting is so important for EHRs:

…[S]uch programs face some unique challenges. Chief among these is that the frontline caregivers and system users who report an event—as well as the staff who typically review the reports—may not understand the role that an HIT system played in an event…

The MEDTECH Act’s Effects

The move to curtail the FDA’s EHR jurisdiction is heating up. Senators Hatch and Bennett’s proposed act exempts EHRs from FDA jurisdiction by defining EHRs as passive data repositories.

Most industry chatter about the act has been its exempting EHRs and others from the ACA’s medical device tax. However, by removing FDA’s jurisdiction, it would also exempt EHRs from AE reports. Repealing a tax is always popular. Preventing AE reports may make vendors happy, but clinicians, patients and the public may not be as sanguine.

The act’s first two sections declare that any software whose main purpose is administrative or financial won’t come under device reporting.

Subsection (c) is the heart of the act, which exempts:

Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records,

Subsection (d) says that software that conveys lab or other test results are exempt.

Subsection (e) exempts any software that makes recommendations for patient care.

There are several problems with this language. The first is that while it goes to lengths to say what is not a device, it is silent about what is. Where is the line drawn? If an EHR includes workflow, as all do, is it exempt because it also has a chart function? The bill doesn’t say

Subsection (d) on lab gear is also distressing. Currently, most lab gear are FDA devices. Now, if your blood chemistry report is fouled by the lab’s equipment ends up harming you, it’s reportable. Under MEDTECH, it may not be.

Then there’s the question of who’s going to decide what’s in and what’s out? Is it the FDA or ONC, or both? Who knows Most important, the bill’s negative approach fails to account for those AEs, as ECRI puts it when: “Default values being used by mistake, or fields being prepopulated with erroneous data.”

Contradictory Terms

The act has a fascinating proviso in subsection (c):

…[P]rovided that software designed for use in maintaining such patient records is validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.

This language refers to information that device manufacturers file with HHS prior to marketing. Oddly, it implies that EHRs are medical devices under the FDA’s strictest purview, though the rest of the act says they are not. Go figure.

What’s It Mean?

The loud applause for the MEDTECH act coming from the EHR industry, is due to its letting vendors off the medical device hook. I think the industry should be careful about what it’s wishing for. Without effective reporting, adverse events will still occur, but without corrective action. In that case, everything will seem to go swimmingly. Vendors will be happy. Congress can claim to being responsive. All will be well.

However, this legislative penny in the fuse box will prove that keeping the lights on, regardless of consequences, isn’t the best policy. When something goes terribly wrong, but isn’t reported then, patients will pay a heavy price. Don’t be surprised when some member of Congress demands to know why the FDA didn’t catch it.

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Adverse Event Reporting: What Is It?

Note: This was originally posted on: EMRandEHR.com
Eric Duncan’s Ebola death in Dallas was, to say the least, an adverse event (AE). Famously now, when he had a high fever, pronounced pain, etc., he went to Texas Health’s Presbyterian Hospital’s ER, and was sent home with antibiotics. Three days later much worse, he came back by ambulance.

In the aftermath of Duncan’s death, the hospital’s EHR, EPIC, came in for blame, though it was later cleared. Many questions have come from Duncan’s death including how our medical system handles such problems. Articles often use the term adverse event, but rarely mention reporting. I think it’s important to take a direct look at our adverse event reporting systems and where EHR and AEs are headed. This note looks at AE systems. The next looks at where EHRs fit in.

The FDA: Ground Zero for Adverse Event Reports

HHS’ Food and Drug Administration has prime, but not exclusive, jurisdiction over adverse reports breaking them into three classes:

  • Medicines
  • Medical Devices, and
  • Vaccines.

Four FDA systems cover these classes:

  • FAERS. This is FDA’s system for drug related adverse reports. It collects information for FDA’s post marketing for drug and biologic product surveillance. For example, if there’s a problem with Prozac, it’s reported here.
  • MAUDE. The Manufacturer and User Facility Device Experience reporting system. If an X-Ray machine malfunctions or lab equipment operates defectively, this is where the report goes.
  • VAERS. Vaccine adverse reports are collected here.
  • MEDSUN. This is voluntary, device reporting system gathers more detailed information than MAUD. It’s run by as a collaboration of the FDA and several hundred hospitals, clinics, etc. (Disclosure: My wife was MAUD project system developer.) MEDSUN captures details and incidents, such as close calls or events that may have had a potential for harm, but did not cause any. MEDSUN has two subsystems, HeartNet, which is for electrophysiology labs and KidNet for neonatal and pediatric ICUs.
DSC04388

MEDSUN Reporting Poster

State AV Reporting Systems

Several states require AV reporting in addition to FDA reports. Twenty-seven states and DC require AV reports, with varying coverage and reporting requirements. Some states, such as Pennsylvania, have an extensive, public system for reporting and analysis.

Patient Safety Organizations

Added to federal and state organizations are many patient safety organizations (PSOs) with an AV interest. Some are regional or state groups. Others, are national non profits, such as the ECR Institute.

The Safety Reporting Paradox

If you delve into an AV reporting systems, you’ll quickly see some institutions are more present than others. That doesn’t necessarily mean they are prone to bad events. In fact, these may be the most safety conscious who report more of their events than others. Moreover, high reporters often have policies that encourage AE reporting to find systemic problems without punitive consequences.

Many safety prevention systems work this way. Those in charge recognize it’s important to get all the facts out. They realize adopting a punitive approach drives behavior underground.

For example, the FAA has learned this the hard way. Recently on vacation, I met two air traffic controllers who contrasted the last Bush administration’s approach to now. Under Bush’s FAA errors were subject to public shaming. The result was that many systemic problems were hidden. Now, the FAA encourages reporting and separates individual behavior. The result is that incidents are more reported and more analyzed. If individual behavior is culpable, it’s addressed as needed.

In the next part, I’ll look at how EHRs fit into the current system and the congressional efforts to exempt them from reporting AEs, a move that I think is akin to putting pennies in a fuse box.

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The Other Talk: EHRs and Advance Medical Directives

Note: This was originally posted on: EMRandEHR.com

The Other Talk: EHRs and Advance Medical Directives

Most of us who have adult children can remember that awkward talk we had about life’s origins. We thought, whew, that’s done. Alas, there’s yet another talk. This time it’s with those adult children and it’s about you.

This one’s covered in Tim Prosch’s and AARP’s book, The Other Talk. The talk, or more accurately the process is how you want to spend The Other Talkthe rest of your life. It’s about your money, where and how you’ll live and your medical preferences. It’s just as hard, if not harder, than the old talk because:

It’s hard to admit that you won’t be around forever and your independence may start to ebb away.

  • You don’t want to put your kids on the spot with difficult decisions.
  • Your children may be parents coping with their own problems. You don’t want to add to their burdens.
  • You’ve been a source of strength, often financial as well as emotional. That’s hard to give up.

Prosch and AARP want to make it easier on everyone to deal with these issues. He covers many topics, but for those of us who live in the EHR world one is of significant importance: Medical directives.

Prosch explains directives and simply says you should give them to your doctor. Easier said, etc. Today, that means not only your PCP, but also making sure that hospitalists etc., know what you want. While the Meaningful Use program helps a bit. It’s still going to take some doing.

Medical Directives and EHRs

EHR MU1 recognizes directives’ importance requiring that they be accounted for:

More than 50% of all unique patients 65 years old or older admitted to the eligible hospital’s or CAH’s inpatient department have an indication of an advance directive status recorded.

This means that the EHR has to have the directives. However, MU 1 only goes halfway to what’s needed. It’s what the EHR does with directives that’s unsaid.

If the EHR treats a directive as a miscellaneous document, odds are it won’t be known, let alone followed when needed.

To be used effectivelyPractice Fusion: Advanced Medical Directives, an EHR needs a specific place for directives and they should be readily available. For example, PracticeFusion recently added an advance directives function. That’s not always the case.

Googling for Directives

To see how about twenty popular EHRs treat directives, I did a Google site search, on the term directive. I got hits for a directives function only from four EHRs:

  • Athenahealthcare
  • Cerner
  • Meditech
  • PracticeFusion

All the others, Allscripts, Amazing Charts, eClinicalWorks, eMDs, McKesson, etc., were no shows. Some listed the MU1 requirement, but didn’t show any particular implementation.

Directives: More Honored in the Breech

This quick Google search shows that the EHR industry, with a few exceptions, doesn’t treat directives with the care they deserve. It should also serve as a personal warning.

If you already have directives or do have that talk with your family, you’ll need to give the directives to your PCP. However, you should also give your family copies and ask them to go over them with your caregivers.

Some day, EHRs may handle medical directives with care, but that day is still far off. Until then, a bit of old school is advisable.

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