Wednesday, June 30, 2010

Consenting Technologies

Yesterday, ONC held a fine gathering at the Grand Hyatt in Washington DC. There were experts, ONC Tiger team members and cutting edge technology vendors displaying and discussing platforms and software for providing patients the opportunity to define granular consent to the sharing of their electronic medical records down to a data element level. Somewhere in the midst of watching that fabulous and very complex technology, it occurred to me that I don’t quite understand why we are discussing all these things. Obviously, we all agree that patients have a right to privacy, and as HIPAA outlines, our medical records ought to be protected from wanton disclosure without our permission. However, the showcased products and the ensuing conversations at the Grand Hyatt were on a completely different level of sophistication.

Physicians have been exchanging patient records since medical records were invented. Today, patients are signing the obligatory HIPAA forms giving health care providers permission for these exchanges, and most doctors use fax, phone, courier (usually the patient) and occasionally secure email to exchange medical records. A typical scenario would be a PCP making a referral – a letter summarizing the problem is usually written, some test results could be attached, a big yellow envelope with some film may be handed to the patient to bring to their specialist appointment. Physicians equipped with EHRs are doing pretty much the same, in a more automated fashion. We do not consider this an invasion of privacy.

It seems that things are about to change. Data, as we all know, yearns to be free, and once computerized, all data will finally become free (literally and figuratively). Instead of having the doctor select the pertinent information to be released based on circumstances and need to know, all our medical data will be available for access by all interested parties. So in our referral example, the specialist would request, or be granted, access to our entire electronic medical record. For most folks, this would be unacceptable. This is where consent comes in.

Newly empowered patients, or consumers, will need to go through their medical records and choose who can see what and under which circumstances they can see it. First we need to locate our medical records, which could be scattered amongst the various providers we see, or according to the best Toyota principles, will be all aggregated in a PHR that we control. So either we log into various Patient Portals, at various institutions, to give our informed consents, or log into our PHR which magically contains our entire medical record. In the latter case, it is not clear what the exact purpose of the consent would be since each provider would retain their own “unconsented” copy of the records.

Assuming I have a computer, and assuming I have access to the internet, and assuming my English is pretty good, and assuming my health care literacy is decent and I don’t have a disability preventing me from working with a computer, and ignoring these minute details, which are surely going to be resolved soon, let’s proceed with consenting. Since we have a specialist appointment coming up, we should decide what the specialist should see. Probably only stuff associated with the reason we’re going to see her for. We can safely check everything else off. Our PCP ordered an MRI, but we would really like the specialist to do her own tests, so let’s check off the MRI too. On second thought the blood tests looked a bit peculiar the first time around, let’s have some new ones, or let’s see what the specialist decides to order on her own. Checked off.

Now we need some general consent policies too. Who should be able to see our genetic information regarding increased risk for breast cancer? Nobody, that’s our own private business and if the insurers find out, we’re toast. Checked off. How about that little episode of depression? Oh, no, that’s nobody’s business either and we’re fine now. Checked off. At this point, all an unauthorized person can see is that we blocked all access to genetic information regarding breast cancer and mental health information. Hopefully it works better than invoking the Fifth Amendment in a court of law.

I understand Electronic Medical Records and wholeheartedly support their adoption. I understand that physicians need to exchange medical data in order to provide care. I understand per incident data exchange and I understand NHIN Direct. I completely understand a patient’s right to obtain a copy of all his/her records and I definitely understand the imperative to protect medical data from profiteering, legal or otherwise.
However, I do not understand the logic of opening up access to the entire medical record just so that patients can go back in and block same access, data element by data element. I also don’t understand the clinical value of a medical record that can be redacted at will without physician knowledge. And most of all, I don’t understand how small rural and underserved clinics, and their equally underserved patients, get to participate in this exquisite technology plan. Will this exercise improve quality of care? Will it reduce costs? Will it reduce disparities?

Monday, June 28, 2010

RECs – Considerations for EHR RFPs

Section 3012 of the HITECH act establishes Health Information Technology Regional Extension Centers (REC) that will offer technical assistance, guidance and information on best practices to support and accelerate health care providers’ efforts to become meaningful users of Electronic Health Records (EHRs).  Each REC shall aim to provide assistance and education to all providers in a region, but shall prioritize any direct assistance first to the following:
  • Public or not-for-profit hospitals or critical access hospitals.
  • Federally qualified health centers (as defined in section 1861(aa)(4) of the Social Security Act).
  • Entities that are located in rural and other areas that serve uninsured, underinsured, and medically underserved individuals (regardless of whether such area is urban or rural).
  • Individual or small group practices (or a consortium thereof) that are primarily focused on primary care.
So far, ONC has granted over half a billion dollars to 60 RECs to accomplish these goals. One of the first steps the RECs need to take is the evaluation and subsequent recommendation of EHR technologies to their constituents.  Whether the REC selects one EHR to work with, or a short list of preferred vendors, or just a general rating system for multiple vendors, chances are an RFP, or at the very least an RFI, will be issued to EHR vendors.

Following the grant announcement several RECs issued (Requests for Proposals) RFPs and some completed the EHR selection process, while most are still in the process of creating RFPs. The few RFPs currently published are by and large based on the DOQ-IT EHR RFP.  While the DOQ-IT document is excellent for an individual practice, it needs some important adjustments in order to serve a REC’s objectives and stated priorities.
  1. Facilitate EHR adoption for several hundreds, to several thousands of providers, in a short amount of time – This objective will require that for an EHR vendor to be considered, it must have the capacity to actually perform such large scale implementations, both in human resources (quantity and quality) and technical infrastructure scalability. The RFP should inquire about both aspects.
  2. All REC providers must be eligible for Meaningful Use incentives – Any EHR selected by the REC must be, or readily become, ONC certified for Meaningful Use. Since there are currently no ONC approved certifying authorities, the closest an EHR can come to satisfying this requirement is by already being CCHIT 2011 certified (comprehensive or Stage 1).
  3. The first priority for RECs is small Primary Care practices with less than 10 providers – There are two concerns here. First, these practices are usually not cash rich, therefore the EHR licensing model, and any additional fees, needs to be thoroughly explored. Second, there are specific features that are more important for Primary Care and not always available:
      a. Full ACOG documentation capabilities and extensive prenatal education materials for OB
      b. Comprehensive Pediatrics module including immunizations schedules for children with special needs and catch-up schedules
  4. The initial REC effort will be directed at providers serving large Medicaid populations, rural areas and other medically underserved patients. Physicians and clinics providing services in these areas have very specific needs, not necessarily found in most EHRs.
      a. Behavioral Health – Any EHR used for underserved populations must include extensive behavioral health modules or functionality.
      b. Comorbidities – The EHR must allow documentation and treatment of multiple problems in one visit, i.e. loading of multiple templates simultaneously and longitudinal tracking of multiple problems, including patient specific care plans and disease management alerts.
      c. Outreach & Patient Education – In addition to the minimum requirements of MU, underserved populations would be well served by sophisticated outreach tools and extensive, culturally adequate, patient education materials. Specific materials for people with disabilities are also desirable. Just having a PHR is probably not sufficient in areas where there are few computers and health literacy is low.
      d. FQHC functionality – Any EHR used in these settings must have all the regulatory reporting (UDS) and billing capabilities to support federally qualified clinics.
      e. Substance Abuse, Smoking and Obesity – It would be beneficial if the EHR would include content and tools to facilitate counseling along with ability to manage group sessions.
      f. Home Care – Any functionality that allows integration of home care activities into a practice EHR would be beneficial.
      g. Medical Home – Functionality built to better support medical homes creation and operations, such as general care coordination and collaboration, reporting and referral management should be helpful. RECs should inquire if EHR vendor has experience with any PCMH deployment.
      h. Rural Health Connectivity – Considering that most REC implementations will occur in rural settings where broadband and Internet connectivity are not yet as reliable as in urban areas, EHRs should provide contingency plans for ISP outages or lengthy periods of impaired response time.
      i. Patient Volume – Most clinics to be served by RECs have very large and complex patient volumes. EHR ease of use and usability features will be extremely important for successful adoption. Other than testing and evaluating recommended products, RECs should also obtain knowledge of a vendor’s Quality Assurance process and the number of Usability professionals directly involved in product development.
      j. Last, but not least, any EHR vendor selected by a REC should be willing and able to integrate with existing State specific technology efforts to support underserved populations. A good example will be the Indian Health Services RPMS and its Patient Care Component, or any other Medicaid sponsored networks such as MO HealthNet in Missouri.
  5. RECs will be engaging in the largest long term EHR implementation effort to date.  It is to be expected that despite best effort some implementations will fail and some practices will be de-installing EHRs. A detailed plan of action for extracting EHR and PMS data from recommended EHR systems is imperative. RECs should inquire about, and contractually request, equitable data extraction processes.

Note 1: Regarding EHR Modules - Although ONC will be certifying EHR Modules, it will be prudent for RECs tol only accept RFP responses from complete products or vendors aggregating modules into complete products. It would not be advisable for RECs to engage in EHR Module aggregation due to the aggressive timelines and shortage of expertise.

Note 2: Regarding Meaningful Use – At the time of this writing CMS has not finalized the minimum requirements for Stage 1 Meaningful Use. It is very likely that the currently proposed requirements will be reduced in scope. However, the 25 certification requirements for EHRs should remain unchanged. Guaranties notwithstanding, EHRs that fall short of those requirements today are less likely to be able to come up to speed and certify in time for the RECs to meet their aggressive schedules. RECs deciding to recommend such EHR products should, at the very least, identify and clearly explain the risk to their providers.

Wednesday, June 23, 2010

Physicians Right to Privacy

As we move to Electronic Health Records (EHR), the debates over security and privacy are becoming more frequent and more poignant. We of course have HIPAA laws on the books and ONC has a Tiger team assembled to recommend privacy and security policies to Secretary Sebelius. CIOs and entire IT departments are all focused on protecting the privacy of patients and their Personal Health Information (PHI). This is, of course, as it should be, but how about privacy of those taking care of patients? Do physicians have a right to privacy too?

As EHRs become more prevalent and interconnected, increasing amounts of clinical and administrative data will be flowing out of doctors’ offices and into the great beyond. Most of this data is indeed patient data, but some of it could be combined, sliced and diced to derive pretty extensive information about doctors. For example, and in no particular order:

  1. Prescribing patterns – Prescription data has been collected and sold to pharmaceutical companies for decades. EHRs will make this much easier to accomplish and the data will become richer and more granular, since it will contain the exact nature of the visit where a particular drug was prescribed or discontinued, including physician notes on the subject. Of course, such information finding its way to public websites would present a novel difficulty if, say, we can look up Dr. X and see that she wrote 30 prescriptions for contraceptives last month, half of which were for girls under 16 years of age.
  2. In the interest of informing patients on physicians’ expertise, a company may decide to publish names and frequencies of procedures performed by physicians. In addition to the fact that the raw number of performed procedures is not indicative of proficiency if not accompanied by outcomes data which is almost impossible to obtain, our beleaguered Dr. X may find a web listing of the number of abortions she performed on teenage girls right next to her name and home address.
  3. Administrative data can provide average times spent with patients, with no differentiation between the 5 minutes required for allergy meds renewal and the half hour you spent with elderly complex patients. Schedule data can also be manipulated to deduce when you take vacations. Is anybody watching your house while you’re enjoying those exquisite Hawaiian sunsets?
  4. Of course the call for greater transparency will create numerous websites trying to provide patients with a Consumer Reports style rating of doctors. Quality measures similar, or identical, to the ones submitted to CMS will come in very handy. If you report that only 20% of your patients have an acceptable Hb1Ac level and I am a diabetic looking for a good doctor, I’d probably pick one with better “outcomes”. The fact that most of your patients are underserved, poor and even homeless and you are pretty much a saint is not evident in your outcomes. Sorry.
  5. EHR progress note data can indicate how thorough you are. If you routinely document only a handful of Exam and Histories elements, maybe I should find a doctor that takes more time and is more thorough, or one who has an EHR that documents all negatives by exception, whether he looked at it or not. There will be very few patients savvy enough to know the difference.
  6. Here is a more interesting possibility. By examining your SOAP notes, computers can figure out your decision making patterns. These patterns can be cross aggregated and will make for very interesting research. However, these patterns, once established, could also become admissible evidence in a court of law.
As data becomes richer and more liquid, more possibilities to monetize physician data will emerge, just like monetization of patient data will become rampant. Fortunately, patient privacy is central to all new standards and policies being created by the Government. By contrast, physician privacy is not even an afterthought. While physicians have always been morally and legally obligated to protect their patients’ privacy, perhaps the time has come to also consider the doctor’s privacy in this brave new digital world.

Monday, June 21, 2010

Deobfuscating HITECH

Software developers sometimes use a technique called obfuscation to protect their intellectual property. They use tools to add, remove and displace the original flow of the code until no human can understand what it does or how it does anything. Judging by the ample confusion expressed by large numbers of physicians, it almost looks like a giant obfuscator has been applied to the HITECH act leaving the medical community to wonder what to do, why do it and how to proceed. The prevailing wisdom is that, for some misguided reason, the Government is paying for EHRs, but there are so many strings attached that it is very unlikely anybody will ever see a dime of the much advertised $44,000.

First we should figure out what these EHRs can do, or more accurately, will one day be able to do.
  1. Store all your paper records electronically in a computer and make them accessible to many other providers of care, including patients. EHRs, if allowed, can also make all your records available to insurers, Government and any other agencies or corporations who manage to obtain access. There will of course be laws and regulations, consents and all sorts of policies in place to prevent or punish unauthorized access. Electronic data is much more liquid than paper based data, leading to better collaboration, better visibility and like all liquids, has better chances of leakage.
  2. EHRs can slice and dice your data and present you with flowsheets for an individual patient and many reports across your entire panel of patients. You could see how your patients are doing, which ones need to be reminded to come in, or schedule screening tests. It’s hard to do that on paper.
  3. Just like your data is available to others, theirs is available to you. You can see medication lists, specialist notes or PCP histories, hospital records, test results and even home monitoring devices input in real time. Coordination of care should become less time consuming.
  4. EHRs can help you directly communicate with patients (and other doctors) via secure email or even secure teleconference. It can automate making appointments, paying bills, obtaining pre-authorizations and even the entire check-in/check-out process.
  5. EHRs can provide you the latest guidelines and evidence, in a patient specific context. Perhaps even CMEs. Computers are supposedly better at calculations and cross checking large amounts of data, hence they could alert you when an error is about to occur or present you with the latest checklists.
No, all these things are not there now. Some of the simplest ones are, and the rest should become reality after enough physicians start using EHRs and enough EHRs get interconnected to form a critical mass necessary for progress.

OK, so where is the catch? Truth being said, there is more than one catch.
  1. You have to feed the beast. Computers cannot deliver any of the wonderful, or less wonderful, things above, unless somebody enters data into the EHR to start with. While most data can be entered by staff, large portions will have to be collected by the physician.
  2. Computers are intrusive. The EHR will make its presence felt in the exam room. It will alter your interaction with your patients. There are tips and tricks to minimize the change, but it cannot be eliminated altogether.
  3. EHRs are not a finished product. When you “adopt” one, you become part of a learning effort on how to computerize medical records. EHRs have “glitches”. The Internet and broadband have “glitches”. Computers in general have “glitches”. People have many “glitches” too. Nobody invented the perfect method for documenting encounters, for viewing longitudinal records, for ordering tests and most important, EHRs are not yet able to communicate with one another on a large scale.
  4. The Government will have easy access to your records. Your performance may be judged (perhaps inappropriately) and reimbursement may be affected. Patients (and their attorneys) will have unfettered access to your records. Mistakes will be found. Little notes you made just for yourself in the paper chart, are not just for yourself anymore.
  5. EHRs can be expensive. They don’t have to be, but they can be. Picking the wrong piece of software, not getting proper training, not managing the implementation process correctly and failing to continuously manage change may cost you a small fortune, mainly in lost productivity. There are no “lemon laws” for EHRs.
My first cell phone weighed over a pound and had huge buttons and a very ugly antenna. My second cell phone was a flip phone and my third one was Java enabled. I now have an iPhone. My first computer was a main frame IBM 370. I was madly in love with the power of that machine. My second computer was an IBM PC. I named him and took him with me on a long vacation overseas and back. I now have a thin and much more powerful Sony Vaio. I could have sat this whole thing out waiting for the iPhone and the Vaio to be perfect, which they still are not, but I would have been left behind I think. I would have certainly avoided the embarrassment of dragging a 30 lb computer through several airports and the excruciating wait for the modem to connect, or the inconvenience of dropped calls every time I drove by an electricity pole. But I would have also missed the ability to help a Hospital keep receiving lab reports on a Friday night and the opportunity to walk a technician through an entire database restoration from a mountain lodge in the middle of nowhere.

If I were a physician in a small private practice today, I would do my research and locate the cheapest EHR that can do what needs to be done relatively well. I would “adopt” the contraption, regardless of the promised $44,000, probably name it Lucifer and keep an eye on it to make sure it behaves itself. And I would try my hardest to become part of the future and part of the solution, because folks, whether we like it or not, paper is over.

Tuesday, June 15, 2010

Kingmaker RECs

ONC has granted many millions of dollars to Regional Extension Centers (RECs) to promote widespread adoption of EHRs, particularly amongst small private practices of primary care physicians. The RECs are chartered to educate and assist physicians and safety net providers with selection and purchase of EHR technology. Much like the Department of Agriculture stepped in to aid farming at the turn of the previous century, the RECs are creations of the HITECH act and the goals are not much different – diffuse Government best practices to small businesses (the controversial aspect of such activities is best discussed separately). It is possible that after the EHR push is completed, RECs will evolve into helping physicians practice better medicine as Atul Gawande envisioned. But right now, RECs are in the process of defining the ambulatory EHR market.

The common knowledge is that the ambulatory EHR market consists of “hundreds” of competing software products and services. Well, there may very well be hundreds of products out there, with hundreds of flashy websites, but very few have a sizable customer base, whith a dozen or so vendors servicing most current EHR customers. HITECH has brought us an influx of new entrants and I am certain there are many more to come between now and 2011. At the same time, market consolidation through mergers and acquisitions is reducing the number of both vendors and products. Just like the Misys/Allscripts merger displaced old Misys products, the Allscripts/Eclipsys merger will definitely retire duplicate or unprofitable products. And there will be more, and probably larger M&As in this space. There will also be the inevitable demises.

So what should a REC do when it comes to helping physicians select an EHR? Should they present several hundred EHRs to the doctor to look at? Perhaps they should limit themselves to the one hundred or so CCHIT certified EHRs? Or better yet send the physician out there to sort through the multitude with a set of instructions on best practices for selection. Chances are the doctor will not even begin to look, let alone actually select something. It therefore falls to the REC to prescreen vendors, at least to a certain degree. RECs are also directed by ONC to form Group Purchasing Organizations (GPOs) and obtain the best possible pricing arrangements for their constituents. Such arrangements are only possible if large numbers of physicians are all buying the same EHR, thus further narrowing the playing field.

Just getting EHRs in physicians’ offices is not nearly enough. RECs are also supposed to facilitate connectivity of their physicians to HIEs and there is ample collaboration between state HIEs and RECs, with some being managed by the same organization. It would be a nightmarish proposition for HIEs and RECs to facilitate connectivity of hundreds of different EHR products. Just like Hospitals before them, RECs and HIEs are likely to select a few EHRs and work on connecting with those first. In an era of universal standards this would not be a problem, but our standards are evolving in parallel with EHR adoption and we have to start somewhere.

The first announcement of short EHR lists came from the two New York State RECs and created much angst in the small vendor community. New York narrowed it down to the usual suspects – mostly large well established EHR vendors. Are New York RECs short sighted? Do they not wish to support innovation and small new products that may turn out to be “the next big thing”? Are they receiving kickbacks from the financially stable vendors? Most likely, none of the above. The RECs must discharge their duties in the here and now. They cannot afford to bet money (taxpayer money) on the “next big thing” and considering that the grants, as generous as they may seem, barely cover the costs of operations, the RECs must mitigate risk. Contracting with a vendor that has “been there, done that”, a vendor that may not have the newest and shiniest technology, but has a boatload of fairly satisfied customers (and unhappy ones too), a vendor commanding an army of trainers and implementers, a vendor that is already connected to many large Hospitals in the State and a vendor with a balance sheet extending well into the past not just into a projected future, is arguably the safest course of action a responsible REC can take.

I would add one more piece of advice to all RECs creating short lists and GPOs. Make sure all your vendors guarantee the ability to extract all data from their current systems. Technology is not standing still and sooner or later game changing software will make its appearance. It may very well be from one of your established vendors, but if it’s not, you have a fiduciary responsibility to your physicians to ensure they can move on to bigger (or smaller) and better things.

Monday, June 14, 2010

CCHIT - Ad Infinitum...

This one doesn’t ever go away, does it? Over at Software Advice, Chris Thorman is trying to evaluate the future of what seems to be the most controversial entity in the EHR business. Will CCHIT thrive or will it fade away into a background of various certification bodies sprouted by ONC’s certification program?

Basically, CCHIT’s expertise and readiness, which far surpasses the yet unknown contenders, should work to its advantage. On the other hand the sheer existence of competition and the simplifications introduced by ONC, coupled vith the rising influence of Regional Extension Centers may eventually push CCHIT and its extensive certification programs into irrelevancy.

Personally, I doubt very much that the RECs will be bold enough to select preferred vendors that have not certified in the past and are not willing to commit to certifying in the very near future, but that remains to be seen. Another factor that is frequently overlooked is the financial prospects of any certifying body. The EHR market is rather small, or at least too small to support a wealth of certifying entities, if they are to maintain a pricing level at or below CCHIT. Anything priced higher than the CCHIT minimal ARRA certification will find no buyers.

And then there is the 800 lb Gorilla in the room. If the FDA decides to exercise proper oversight over EHR products as they do with PACS, lab software, blood banks, etc., the entire certification landscape will be turned on its head.
We do live in interesting HIT times…..

Chris Thorman wants to know what you think about CCHIT’s future. He has a nice little survey and you can see the results there too. So voice your opinion here.

Wednesday, June 9, 2010

Do EHRs Kill People?

Back in the times when EHRs were just EMRs, they had a very simple and humble mission. The software was supposed to help providers of health care services better manage their business. EMRs were supposed to help physicians adhere to CMS documentation rules, automate patient flow management and get rid of all the mountains of paper floating around a typical medical office or hospital. It was assumed that EMR software will increase reimbursement rates, streamline workflow and even make the doctor more efficient. After all, every other industry that switched to computerized business management realized bottom line improvements.

Along the way, bolder statements started appearing, mainly from EMR vendors trying to sell their wares. EMRs could also reduce medical errors. The most common argument was for the benefits of replacing the notoriously illegible physician hand writing. Prescription errors would be reduced if only pharmacists and nurses could get a nice legible script. Then came the frequently misplaced paper charts. If the chart resides in the computer, it cannot be misplaced, it is always available to all and it is complete. All the information you need right at your fingertips, regardless of your physical location. It could save lives or at the very least, it could save time. The EMR was nothing more than an electronic chart. One vendor went so far as to create a computerized image of a yellow manila folder with tabbed pockets for various items in the electronic chart.

Nobody thought the electronic chart needed to be regulated by the FDA any more than the paper chart was. After all, the EMR was not providing medical care; it was just a more effective place to record administered care. Or was it? There is a funny thing about computers. They have a mind of their own, a mind created by programmers, a mind which makes them interactive. A paper chart is passive. If you want to see all lab results in a paper chart, you have to decide where to look and actively flip the pages. If you missed one page, it’s your omission, not the chart’s mistake. If you want to see all lab results in an EMR, you click a button and the software does all the paging returning a convenient list for you to look at. If the software missed a page, it’s the software’s fault, not yours. The software is controlling what you see and how you see it. This small fact renders the electronic chart a full partner in delivering health care; it is now a medical instrument.

And then the EMR grew up and became an EHR. The EHR performs tasks for you, like calculating dosage for medications or just simple BMI. The more advanced EHRs presume to give you advice on what to order for a certain condition, or what not to order based on what it knows about your patient. There are EHRs now, and there will be more in the future, which communicate with other software and automatically, bring in medical data and place it in the chart. This sophisticated software makes decisions regarding patient identities and about schedules for preventive care and disease management. Computers are not infallible. Their mistakes are called “bugs” or “software glitches” and just like the nurse or the medical records clerk sometimes placed the wrong piece of paper in the chart, EHRs can, and do, corrupt medical records. Incorrect, incomplete and indecipherable medical records can lead to injury and even death. But does it really happen?

Do EHRs actually kill people? 

The Huffington Post has been investigating this exact question. Between January 2008 and February 2010, the Huffington Post identified 237 reports in the voluntary incident reporting FDA database related to HIT, including 6 deaths and 43 injuries. However, a closer looks reveals that only a small fraction of these reports are actually related to EHRs per se. Most reports involve PACS, medication dispensing systems, blood banks and other FDA regulated equipment. Out of the 6 reported deaths (2 of which occurred in 2006), one was related to a PACS system latency, another to human error in labeling an x-ray cassette and another to a hospital pharmacy system. 2 deaths were attributed to system wide failures of CPOE and one to lack of intuitiveness in display of notes. As to injuries, out of the 43 reported, I could only count 17 directly related to EHR software and most have to do with CPOE.

Is this the tip of the iceberg, as some contend? Are there many more unreported deaths caused by EHR software? There may be, but frankly, the evidence of massive numbers of adverse events is not there. It does, however, stand to reason that voluntary reporting would be incomplete and the fact that only a couple of EHR vendors are represented in the FDA database is suspicious to say the least. On the Health Care Renewal blog they are engaging in what I think they know are rather creative mathematics, to project hundreds of thousands of injuries per year if, and when, EHR adoption really takes off.
If EHRs become as pervasive in everyday medicine as ONC is proposing, every patient will eventually be touched by an EHR.  It is very likely, that some errors will be prevented by the sheer existence of an EHR, but new and unfamiliar errors will also be introduced as side effects. Of course, the potential benefits must be shown to significantly outweigh the hazards, and we already have accepted mechanisms for such assessments.

While ONC is exploring collaboration with the FDA, and the FDA seems willing to engage, the customary counterargument is that FDA processes will stifle innovation and make EHRs unaffordable. There is validity to such arguments, but as long as money seems to be no object for HITECH, maybe we can spend some of it on devising reasonable and affordable methods of testing patient safety, both pre and post market. Innovation will take care of itself and the alternative is unconscionable.

Sunday, June 6, 2010

EHR Bargains Review - Amazing Charts

(Survival Tips for Small Practices)

Amazing Charts is the best kept secret of the EHR industry. It’s like that little Italian restaurant on a back alley behind some church known only to locals, where the food is exquisite and the prices are dirt cheap and you won’t find any tourists hanging around. You don’t see any Stimulus Conferences sponsored by Amazing Charts and as a matter of fact, you don’t see much marketing efforts. Amazing Charts is bought and sold largely by word of mouth.

The company was founded by a physician in 2001 and it is still privately held and self-sustaining with about 3500 customers. There are many small EMR companies out there, some owned by the doctor who started them, so why is Amazing Charts special? Amazing Charts is 2008 CCHIT certified and Amazing Charts can be obtained for about $125 a month, inclusive of all the bells and whistles that come with CCHIT certified products. This is an anomaly. Most CCHIT certified EHRs cost at least 4 times as much and all have additional charges not obvious when you start out. The 2008 certification is very important because unlike older certifications, 2008 includes interoperability. For EHR products certified by CCHIT in 2008, obtaining Meaningful Use (MU) certification will be almost trivial.

The Model

Amazing Charts is a client/server EHR. You download it from the company site and can try it out for 90 days. If you don’t like it, no harm done. If you like it, you can buy a license. This is not SaaS or web based software. The server sits in your office and so do all your patient records. However, I am now logged into an instance of AC which a friend of mine across town downloaded to try out. I am using Remote Desktop and I see no slowness or any performance issues. So if you are adamant about having your server sit outside your office, you can do that. However if you are set on getting a browser based EHR, this one is not for you.


The basic AC price is $995 per provider, where provider is defined as an MD, DO, PA or NP. This however will not be sufficient for Meaningful Use. An additional $500 per provider/per year will buy you support (including a very convenient live chat), upgrades, electronic prescribing (from NewCrop) and annual maintenance for your other interfaces. This brings up the price to $125 per provider/per month for the first year. Interfaces for most labs and radiology are free, as they should be. Interfaces to office equipment and practice management software run between $250 and $500 (one time fee), which is the very bottom end by industry standards.

AC offers off site backup services for $250 per practice/per year and like many other EHR vendors, full service billing (from third party partners) for a flat 5% of net collections. The percentage is low for Primary Care, particularly Pediatricians, but a bit high for interventional specialists.

As far as training goes, AC has a wealth of online training videos and the software itself is pretty intuitive and easy to figure out on your own, at least when it comes to basic functionality. Onsite training is billed at $1500 per day, which is in line with industry customary charges.


Amazing Charts has all the administrative features of a modern EHR, including scheduler, messaging, detailed demographics and role based security. All the CCHIT clinical advanced features are also present including order sets, registry, clinical decision support, alerts and most important ability to export the records in CCR (Continuity of Care Record) format, which means that if for any reason you choose to buy a different EHR down the road, you can get your patient data out of AC. One very important thing to note is that AC’s documentation templates are not based on discrete data capture, and therefore are not point-and-click. You can create prefilled templates by adding canned text and type or edit the rest. You can also use Dragon Medical if you prefer dictation. Pretty simple stuff and very fast, but this may prove to be a problem if the Government insists on discrete data reporting.

AC does not currently have a full Practice Management System (PMS). There is no way to work claims in the system. You can create claims and export them to another system or drop them to paper for your billing service, but if you do your billing in house, you will need a PMS. On the AC user forum people are talking about a PMS module due out soon, but I have not seen any definitive dates. This is particularly important for Meaningful Use, since it requires that you do Eligibility checking and that claims are electronically submitted. It would be interesting to see how AC will deal with these challenges, if MU is not scaled back.

AC does not offer a Patient Portal, or PHR, but it could probably be integrated with third party portals like Relay Health and that CCR can be exported to commercial PHRs. There will most likely be costs associated with such integration.
One of the nicest features of Amazing Charts is the user community and the very active forum for discussions, assistance and just plain camaraderie. The forum is open to all, so you may want to take a look.

Bottom Line

Amazing Charts should most definitely be on the very short list of any price conscious small practice, particularly Primary Care and Internal Medicine. The price of $166 per month for year one and less than $83 per month afterward, is a great bargain for a CCHIT certified product and according to the 2009 AAFP EHR User Satisfaction Survey, Amazing Charts is ranked at the very top of the heap, outdoing all the big and expensive products. If, or when, AC adds a PMS that is as comprehensive and as friendly as the EHR, it should move to the top of the shopping list for any small private practice.

07/18/2011 Update: Amazing Charts EHR Version 6 is ONC-ATCB certified for 2011/2012 as a Complete EHR. It is also pre-market CCHIT certified for 2011.