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There have been a large number of articles published regarding electronic health records.  I wanted to share my thoughts given that Health IT an area that I believe has a tremendous amount of potential.  This topic is nothing new, it has been discussed, tried, abandoned, and retried a number of times.  Things are different now though in some important ways.  For starters it has a great deal of federal attention, President Obama campaigned on the subject and he has justified it as a big step in helping to improve the economy.  Secondly, the tools needed to facilitate this type of system are a lot more powerful.  Handling large amounts of unstructured data and classifying, tagging, and searching has all become relatively easy.

So why hasn’t there been more progress on this front?  Technology really has little to do with it, technology is actually the easier part of the total effort.  There are several answers and they can vary slightly but it really boils down to the same reasons so many enterprise content management initiatives fail – because there is a lack of analysis, requirements definition, and careful strategic planning up front.  Plus, once systems are deployed, there isn’t sufficient governance and it quickly becomes a support and maintenance headache so the benefits and your ROI disappear.  Something as complex as electronic health records can also be hampered by key stakeholders from different areas failing to agree on a core set of requirements and policies in order to move forward.  If there isn’t a commitment among these interested parties to work together towards a common set of goals and objectives producing a successful solution will be extremely difficult.  This has certainly happened in the past but hopefully with the current momentum this obstacle can be overcome.

One of the key things for organizations planning this type undertaking is to understand and accept that it is not a one time thing.  These aren’t single projects they are programs.  Many projects have failed because the scope becomes way too ambitious and requirements are never properly defined.  With something as complex as electronic health records getting to a refined, specific set of requirements that can be implemented is challenging at best.  Which is why these programs should be broken up into a series of smaller, more tangible projects with scope that can be properly defined and is obtainable during a reasonable period of time.

Taking on more, smaller projects allows you to set more realistic goals, minimize risk, and learn from each iteration so you deploy a more reliable system that meets expectations and yields positive results.  I can’t stress the importance of properly defining requirements down to a specific level, if the requirements are ambiguous and cannot be broken out into use cases you will not wind up with a sound design and the solution will more than likely fail to meet expectations.  I am going to leave this point here since I am starting to cross over into software development methodology and process areas and I have whole separate article planned for that subject.  It may take more than one if I really get on my soapbox!

There certainly have been some good examples, if you haven’t read about it check out the Delaware Health Information Network.  The DIHN (pronounced The Din) as it is lovingly called has been an ongoing program and has been pretty successful.  Will it be a model for other states and possibly more?  I can’t say for sure but having a new VP from the great state of Delaware certainly can’t hurt!

So what can be done to help ensure that an electronic health records system is successful?  For starters realize what I mentioned above, it isn’t a single project, it is a program made up of multiple projects driven towards a common goal.  Of course stakeholder support and resources are a given as with any program but having stakeholders involved that know the different parts of the industry (i.e. Physicians, research, clinical, etc.) and are committed to the common goals is vital.  As with any type of record, health records have compliance regulations that have to be met, the most notable of course is HIPAA.  This is a risky area for electronic health records systems, one that has stumped efforts in the past.

How do you ensure patient privacy when these records become digital, especially with so many potential access points?  This is a big reason key stakeholder input is critical and why there is a great need for governance of the solution once it is deployed.  Roles and permission levels can be established but it is the subject matter experts that need to define them in order to help ensure accuracy.

Once a system is deployed the Governance Committee should be the authoritative body that provides change management guidance and helps ensure the common goals of the solution are being met, including compliance.  As with any good program a road-map should be drawn so the team knows where they are and where they need to go.  The road-map should define key milestones for the program and basically layout the projects to be undertaken along with their high-level scope.  Earlier milestones will probably be more specific and it is OK if future milestones are more nebulous, this should be a living artifact that is revisited, and potentially revised, after each individual initiative at least.  The goal is to lay a solid foundation and build upon it with additional functionality while also factoring in changes in regulation and in the environment.

Although not as important as the aforementioned functional and human factors in ensuring success,  technology certainly has an important role to say the least.  Using content management platforms effectively with intelligent classification, metadata standards, and search applications to manage, relate, and access these records will be vital.  Usability is usually an after thought which is why new system adoption and sustainability can be difficult so it’s role in an initiative like this will be huge.  If the system is difficult to use and frustrating for the end user they simply won’t adopt.  You can build the best solution with all the functionality one could ever need but if nobody uses it the effort will still be an utter failure.  Using proven usability techniques and best practices will help facilitate positive results.

With any major industry shift towards technology, especially with as big as this movement is likely to be, the establishment of certain architectural standards will go a long way to help prevent data from being siloed and to make sure the information can be shared and can cross systems.  There has been success on this front as well that can be used as examples, the Global Justice XML Data Model is certainly one.  Another standard which is in a related area is Regulated Product Submission which is a standard that would allow regulated organizations such as those in the Medical Device, Pharmaceutical, and Veterinary Medicine industries for example to submit regulatory information to the applicable agencies using a single standard message format.

The potential benefits to electronic health records systems are there but what is debatable is whether or not it is realistic to think we can get there.  Eventhough there is strong support there are also those that feel that it is too grand a goal and that the benefit is simply not there.  I was just reading an editorial in the newspaper today where the authors basically said that the money for electronic health records technology would be better spent somewhere else, in fact these authors cited statistics that indicated that this type of technology may actually detrimental to health care.  Sorry, I just can’t buy that.  I just don’t believe we have been doing this long enough and effectively enough to gather accurate data on the subject.  Are there other areas of the health care industry that need funding, of course, this isn’t a silver bullet and to think so could possibly set unrealistic expectations and doom the effort before it ever really got going.

I for one believe that we should, can, and will get there.  Make no mistake, it will be a long complicated journey but one that is long overdue and it looks like it will have a great deal of Federal funding and support which will definitely help.  We really can’t afford not to take this step.  Many experts agree the current state of medical records contributes to rising health care costs.  Furthermore, there is a great deal of knowledge that is sitting there but isn’t being utilized simply because it can’t be found and linked together in context.  I mean, when you go into your Doctor’s office or into a lab to have a test performed do they pull up all your information digitally in a unified context?  No, I am sure they don’t, they walk back to those rolling file bins and pull your folder with hard copies of all your health records, once they find it that is, and only for what you have had done with that Doctor or by that clinic.  Now, think about it again, what if your Doctor is able to have all your records including x-rays, lab results, etc. from anywhere at her finger tips and can be referenced easily?  Or what if you move or are out of town and need to visit a Doctor or hospital and they can have all your records pulled up within seconds?   Once it starts to be put in perspective it becomes a very compelling argument.

What I think has the potential to be a tremendous benefit and improvement in overall health care but isn’t being talked about too much are the eDiscovery possibilities that begin to open up.  Think about it, if this information is digital, well attributed, and classified (content management professionals reading this are chuckling at this notion of ECM Zen but stay with me) this starts to not just be a system that manages discrete electronic health records it starts to become a knowledge warehouse.  For example, with all all of your health records stored this way your Doctors can cross reference past lab results and your history to make a better, more accurate diagnosis.  Intelligence can be built in to flag items if certain tolerances have been met and send alerts.

Reporting across geographical areas can be generated to identify potential outbreaks and if you have ever had the flu you certainly want Doctors and organizations like the CDC to have all the information they can at their disposal.  I genuinely believe that this will not only improve our economy and our health care system but that it will lead to more cures and better health in general.  Health records hold a great deal of valuable information and but they suffer from the same plight that a great deal of other content does, not that it doesn’t exist but that it can’t be found.

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14 Comments

  1. bill

    Sorry to be a curmudgeon – not. There are no technical issues, only people issues. Sure it’s possible, but I don’t think success is likely, not because of technical issues but because of political, fiscal, and social issues. But maybe I am too optimistic about the erudition of the American taxpayer in 2009.

    The Apollo program, in 2005 dollars, cost $135 billion, and took about 10 years, 500k employees and contractors in NASA and about 20,000 private suppliers. The U.S. landed a man on the moon in the middle of the Vietnam War and the Civil Rights Movement, and the rest of the social upheaval of the 60’s. I was there. Kennedy set the goal, and Johnson and Nixon carried it out, but only because the citizens of the U.S. thought it was a worthy goal and paid for it with their taxes. That was 40 years ago this coming July. Velcro and Corningware, plastics, transistors, lasers, microwaves, fuel cells, even hydroponics and cardiac conditioning all fell out as byproducts, and changed lives in remarkable ways.

    Do you really believe a program as personally invasive as an ubiquitous national health database – your innoculations, your gene markers, disease predispositions, surgeries, allergies, the number of flu vaccines you’ve taken, including a record of your travels before and after you took the flu shot so the CDC can track it, etc., that tells all to your employer, your doctor, and your insurance carrier, that is free of failure and fraud, that is fair to all, and that facilitates the epoch of glorious, radiant health will be a good thing that taxpayers will rejoice over, much less be remotely desireable, much, much less be fiscally and technically feasible?

    Reply
  2. Chris Schassler

    The simple answer is yes…Do I believe it will be easy? Of course not. But if it means potential improvement in our overall health and a less costly system isn’t it worth it? Do you really believe that there isn’t more of these failures and fraud now? Do you really think our current system is fair to all? Maybe it is time to refocus the direction of your curmudgeoness and make sure it is pointed in the right direction. If you read carefully I mention that this can’t be a single huge project and be expected to succeed. But, if it is done in phases with initial support in the right places individual successes can be achieved and people will be more apt to get behind and support it.

    I understand where you are coming from, it is obviously a sensitive subject and maybe I am too much of an idealist but I believe there is a lot to gain. Plus, it is going to happen regardless of what you or I think so we may as well try and make sure it is done right.

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  3. bill

    I apologize for the “cynicism” – it’s intended to generate discussion. However, I still believe we have to view any kind of ubiquitous personal information system with considerable caution. Not only that, it really becomes our responsibility to protect the public. Such a system is unprecedented. I agree that it eventually be done, but it will come in stages, like the Transcontinental Railroad 140 years ago, and putting men on the moon, 40 years ago. Both of those projects had enormous technical challenges as well. Many said they would fail.

    What checks can we design and build into the system at each stage of development? We have to make sure safeguards are added to protect privacy and security, as well as integrity of the information. All good intentions aside, legislation cannot really protect us. It is still up to analysts, systems designers, and integrators to understand both the social impact and technical challenges, as well as maintain constant vigilance to protect the most sensitive of information. We of all people understand how systems can be violated technically, either by accident or intention. We cannot be cavalier in applying technology as if personal medical history are merely abstract data points and structured content. So I’m proposing a higher degree of project ownership.

    We don’t have any margin in this case of underestimating the complexity and difficulty of bringing this to success. However, you may be correct in your optimism. Just as the Apollo program brought huge collateral benefits to the U.S., perhaps larger economic benefits beyond the electronic health records system itself are in the offing.

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  4. Chris Schassler

    I certainly appreciate the generation of discussion, that is what we are trying to accomplish. I understand and agree with your points. It is a very sensitive area but so are many others that are already digital. Let me give you another example, ACH (Automated Clearing House). This wasn’t a very attractive idea when it was first proposed. I mean, health records are one thing but we are talking about people’s money and financial records here. There had to be incentive for it to work and now can you imagine a world without direct deposit or online banking? Rules and regulations for this financial network are set by the Federal Reserve and by an organization called NACHA-The Electronic Payments Association. I am not talking about legislation, I am talking about governance, monitoring, and policing of the system. You aren’t going to just pass some laws, write some checks, and walk away. As you state, this is way too big for that. It needs to be governed like ACH to ensure safety and integrity of the information.

    Health records are very personal and they should be treated as such and I certainly don’t think of them in a cavalier manner at all but I personnaly believe that they would be better protected in electronic format in a system rather than floating around Doctor’s offices, labs, etc. The initial regulation of privacy are there – HIPAA, The Privacy Act, etc. they just need to be interpreted into a digital implementation similar to 21 CFR Part 11 (https://en.wikipedia.org/wiki/Title_21_CFR_Part_11). The subject matter experts will have to be the ones that work hand-in-hand with analysts, etc. to make this work. The critical part to this program will be the initial stages of analysis and definition, which is really before any real serious technology needs to be touched. There are many smaller, existing attempts and implementations that can be used as examples and would provide a great deal of information about the risks, etc.

    There are certainly going to be those that will want access to the data, whether it is for some gain or just to see if they can. This is no different than any other major system and, as you know, technical measures have been around for some time to help prevent unauthorized access. Obviously, no system is completely secure, no system. The key is to make it too difficult to be worth the trouble and that can certainly be accomplished. Will there be mistakes, certainly, will there be breaches, possibly, but can you think of a system that doesn’t have that risk. All the more reason for a sound scope and direction as well as governance to ensure that if a security hole is found it is closed quickly.

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