It is not the EMR that sucks it is your lack of a information governance strategy

Hospitals are drowning is technological deficits; aging equipment, poor information security, unusable electronic health records and importantly no way to effective share patient records with patients or partners. A recent study shows that two out of three hospitals are not meeting HITECH standards for Health Information Exchanges. The authors note that even though there are fines (see here for HITECH fines), it is unlikely that these will spur adoption of health information exchanges (HIE).

Bernie Monegain (Editor Healthcare IT News) does a great job summarizing the article. From a software vendor perspective this seems like a perfect storm; a gap in capabilities, upcoming deadlines and a change in revenue models. In any other industry there would be lines of vendors at every hospital's CFO's door trumpeting their ability to help them meet their deadlines. Unfortunately the usual suspect vendors in HealthIT have not seized the opportunity (see here).

As I have mention before this is where ECM, WEM, etc vendors should be stepping in to fill the gap.Hospitals of all sizes will need to be able to confidently exchange patient information and make it available to patients once Meaningful use 2 standards for patient accessibility come into affect. Providibng a mechanism to share patient information in a standardized, secure manner is not a nice to have item, it is a required item to meet obligations-it should be on every hospital CIO, CFO and CEO's radar.

It also speaks to the larger problem of what electronic health records are strategically versus the narrow software characterization. Healthcare providers and thought leaders need to acknowledge the software sucks, and is not the best place to share and view information. It is just a dumb database designed to HOUSE patient information in a safe manner- as the name suggests a EHR is part of a records management strategy.

Electronic Patient information has the potential to increase the efficiency and cost effectiveness of healthcare delivery. The problem is the variety of solutions deployed by individual healthcare practices makes integration at the regional and national level difficult. As a rule they have been bought as point solutions to a immediate problem rather than as part of a healthcare information governance strategy.

It is time to look past a single solution that has a single set of technical specifications and build a system that manages data access.

As with any application rationalization process, it is important to define the costs, benefits and integration needs for any new enterprise application. Make no mistake; Health IT can no longer be a single application portfolio, they have to move to an ecosystem approach based on both clinical and administrative needs.

The failure of the single point solution of EHR/EMR has cause many IT professionals to take a negative view of information technology itself. As I have mentioned before, the problem is not the storage of the information it is how to access the information- it is a content management issue-be it ECM, WCM or -gasp-(SharePoint). EHR.EMR systems are horrible at providing access. For meaningful use 3 compliance and for your external marketing you need some kind of content serving system.

For organizations in a position to move to the newest EHR/EMR products, there may be no reason to have an additional system.For everyone who doesn't see a rip and replace in their next five years, consider how all the devices and partnerships that you have (and will have to grow to stay in compliance with Meaningful use).

You have a variety of regulatory items to think about as you develop your information governance strategy:

HIPAA 5010 covers Electronic data exchange(EDI[X12]) compliance standards as mandated for 1/1/2012: It covers exchange of all data transmitted by FTP, HTTPs, etc. Also encompasses the letter and number codes used for identifying file types during transactions. 5010 is largely an attempt to standardize the file codes in a way that increases security through in-flight encryption with de-crypt at each end. This is only possible if there is a standard metadata set.

ICD-10 is completely different it is the International Classification of Diseases (Rev. 10). This is used mainly for e-billing purposes as part of the diagnostic reference. It is not the official standard in the US until 10/1/2013, HIPAA 5010 EDI standards is a prerequisite for use of ICD-10.

Device access Smartphones and tablet computers represent the next wave of technological innovation in healthcare not to mention medical devices and consumer health apps (see here for more thoughts).

Mobile is a key aspect of your long term success. Hospitals have a variety of high earning "part-time" and ad hoc employees with their own businesses to run. You need a way to integrate their independent process and access into your secure information systems.

As with any access decision the type of information that can be accesses has to be balanced against the need for audit and security. The key is to remember the needs of end-users:
Doctors need access to all data, so restricting parts of the records is not an option.
Nurses need to update records on the fly.

IoT devices- There has been a lot of new devices for use in healthcare- patient owned health apps, mobile phones and wireless medical devices (see here for more on this). One of the key short comings of today's EMR/EHR products is their lack of abilities on the user experience front. Hospitals need to move away from single point solution planning for applications to a information management strategy that includes integration of outside data- whether it comes from patients, partner clinics or device vendors.

IT managers need to take the initiative and do these three things:

1. Ensure that the process involves care providers and administration in the same room. These meetings cannot be for show. All decision makers must be involved. 
2. Get to know who the key decision-making doctors are in each department and develop a relationship. Some doctors are in favor of EHR find out who these are in your hospital/clinic and involve them in building a strategy for how to attack the implementation. 
3. Get care providers on-board during the demonstration phase. Take your key decision makers through the products ask questions about the mundane parts of the software (first impressions of the GUI, how to access the records) not just the big picture items.

Clinical data random information

I've become an information hoarder. As I spend more time thinking about Information Management and speeding the move to better technical systems, I am amazed how general the principals of design are between the different industries.

Here is a noobs (i.e. me) "plain spoken" understanding of a key term in managing patient data across hospitials and for predicative analytics and personal health decison making.

Level setting (i.e. in general the definition of Clinical data warehousing) Clinical data warehousing is a patient identifier organized, integrated, historically archived collection of data.

For the most part the purpose of CDW is as a database for hospitals and healthcare workers to analyze and make informed decisions on both individual patient care and forecasting where a hospital’s patient population is going to need greater care (i.e. patient’s are showing up as obese; therefore the need for specific hospital programs to fight diabetes are a good idea).

Data warehousing in healthcare also has use in preparing for both full ICD-10 and meaningful use implementation. For example; McKesson through its Enterprise intelligence module probably has plenty of CDW management capabilities the only interested in meeting the upcoming ICD-10 and meaningful use deadlines. These kinds of worries are only for US hospitals. However since Canada requires ICD-10 compliance for all EMR systems this does present a benefit to Canadian healthcare.

In principal since data warehousing at its core is about building a relational database and should be EMR supplier agnostic. Since McKesson is an ICD-10 and meaningful use- ready supplier, the database itself should conform to standards that would allow general solutions to be used. This article goes through some of the potential benefits and pain points. It is tailored to clinical trials but the underlying message that building a CDW is a ongoing procedure is the same for other uses.

One example of how this may be done is Stanford’s STRIDE; they used HL7 reference information model to combine their Cerner and Epic databases. This is part of a larger opensource project that may be an option if an organization has some development expertise.

https://clinicalinformatics.stanford.edu/research/stride.html

Since the main user of CDWs tends to be the people doing the analysis (current buzzwords for search for analytics include:BI, Predictive analytics, enterprise planning, etc) it is probably useful for Health IT professionals to understand its WHO and WHAT the CDW is for within the organization...i.e. have a full blown Information Governance plan that places a value on information not just a risk assessment. 

Security without usability isn't better healthcare

I spend a lot of my time understanding how information is stored, accessed and protected as part of my role as a IT analyst. I always am astounded at how little of what is standard practice in many industries as not filtered over to health care and/or life sciences (Pharma+Biotech+academia).

The recent hub-bub about ACA (AKA Obamacare) has completely yelled over the real transformation opportunity in healthcare. Up until the recent deadlines and political fights regarding ACA "everyone" was really concerned about meaningful use. The TL;DR version of the MU legislation is this: make information available to care providers and patients.

So what are we really talking about here? It is really pretty simple; it is information management and the processes that guard against mis-use while enabling productivity.

Lets be honest the EHR/EMR solutions implemented at most organizations do not enable productivity or protect information. Doctors hate them because they do not fit their work patterns (see here), hospitals are have significant issues with data protection (see here) and importantly it is not mitigating the biggest risk to patient outcomes (and hospital liability) (see here).  

It is time to re-think the information silos in healthcare.

So if a single poorly accessed EHR is not the answer, what is?

I would argue that we need to think about this based on information flow and how we expect the value to be delivered. In this case patient care.

An interesting model to think about is the Canadian delivery model. For example; Ontario E-health has determined it is neither cost effective nor timely to build a single system for every hospital.  At the moment, 70% of all physician practices and hospitals already have some sort of EHR system in place. So rip and replace is not an option, the reality is we need to make lemonade.

Since Ontario funds the hospitals through direct allocation of tax revenue, it is loathe flush that money down the drain. 

Therefore the best approach is to control the data itself (including digital images, prescription history, surgery, etc) and letting the individual hospitals control how they view and use the data. 

In other words- Make it easier to access information based on who you are and what you need the information for!

Focus on the Information exchange layer

Consolidated Information Management layout for Patient care focus. 

So how do we do this without moving to brand new systems and shiny new toys?

The same way every other industry is doing it; especially low margin high risk industries such as Oil and gas, Insurance and Manufacturing. Keep the clunky but very secure system and take advantage of the new technologies that enable information sharing. Instead of all-in-one solution add an ECM or portal to manage rights, search and presentation. It will be more cost-effective than doing nothing or rip and replace.

This structure controls movement and access to patient data, allowing for quick access to the appropriate information based on job and location.  It provides a structure that takes advantage of the current investment in a secure database yet provides a flexible layer that is designed to convey information in context for end users. 

This may not be the best system or the system that you would design from scratch with an unlimited budget, but it gives a long term flexibility AND doesn't require a rip and replace of your current EMR/EHR. It should provide very good, highly usable healthcare at a reasonable cost.

The way they are going about the change may not be splashy but it will work for both patients and doctors- that’s a great thing. The one thing it won’t fix is the doctors who refuse to use it-and that is a bad thing.

There is additional cost involved in this model but if teh doctors and nurses do not use what you have now.....would salvaging that investment be better?

Love any comments or critique of the model.

Health IT and clinical research

I recently returned from the E-Health Canada conference in Vancouver. I was there as an analyst for Info-Tech research group. I spoke about secure use of consumer devices in healthcare and the potential of cloud computing as a flexible model to deal with CoIT.


I was pleasantly surprised by the IT knowledge level of the nurses and doctors that attended the conference. Why was I surprised in this age of consumer devices and self service tech? Well I spend a fair amount of my time talking to and about IT departments. The impression that I get from many of them is that while most people can set up their email on their phone they remain largely clueless about the actual tech itself.  


Well, there is certainly a core of nurses and doctors that understand the tech and have really great ideas for how to make it work better in the context of healthcare delivery. I was left with the feeling that many remain frustrated with the current solutions and the pace that E-health is moving forward. The major areas of frustration were around content delivery and system upgrade for usability. I would summarize it as “You must do something; protect the data but be flexible on the device used”. Technology should allow doctors to spend more time looking and talking to patients not with their nose buried in a tablet. Just placing a tablet in the doctors’ hands doesn’t mean it will lead to increased use of the IT solutions for healthcare.


While some may point to this as a technology problem, it was clear from talking to the vendors that the solutions available today can meet the demands that hospitals are placing on IT. As someone with a past on the research and has dabbled in clinical research it was refreshing to know that there is a variety of solutions out there to make clinical research easier. What was interesting was how similar healthIT problems are to many other industries. In my opinion the issue is now about getting the best out of the tech not when will the tech exist.


 In other words its about getting the users and the admins on the same page. 


As someone with a deep passion about Rare diseases and use of high level biomedical research its somewhat frustrating that the system that is in use today is so antiquated. The upgrades available today could add so much intelligence to how we treat Rare diseases in particular. 


The new areas of stem cell therapy and epigenetics hold a HUGE promise if we can understand the relationship between disease and biology in these patients. Since they are so rare at any given location it is imperative that we have a way to share the data that is safe enough to share patient history across borders.

Rare diseases and open access.

Ive found myself completely mesmerized by the open access/open science debate. As a recovering bench scientist, it has made me think about a variety of things but one that is really interesting is the implications for Rare disease research and speed of turning great benchwork into viable drug targets. Ill deal with the larger debate on open access separately but I wanted to put forward something today(Feb 28th 2015 Rare disease day). 

2016 update: In my opinion not much has change in Rare diseases in the last year. There have been some moves forward but like anything in the drug and/or therapeutic research- it is time consuming. I hope that the silence is because we are getting to the point where folks have rolled up there sleeves and are working not talking. 

I am really excited about the prospects for increasing the speed that potential drug targets can go from bench to bedside. The new technologies (gene sequencing, clinical data) can provide faster turn around time through efficient data sharing and new genomics technology. The real potential pay off is through new clinical data that will be available once EMR is implemented widely. The value of that much data combined with the new genome sequencing technologies can really provide some much needed guidance about the genotype phenotype relationships that may link certain rare diseases. I say may since it will really come down to data quality and wide dissemination of that data. Getting clinical data into the hands of molecular biologists and biochemist who can do the bench research is vital to drug design. 

2014 Update: With the roll-out of ACA starting to happen and the FDA crackdown on 23andMe. The landscape for studying and curing Rare Diseases just got a little better. For more information on the 23andMe nonsense there is plenty of information on the imbroglio but this one from the Huffington Post is the least sensationalist. My opinion is that the FDA made a decision based on the specific businesses lack of response it is not an indictment of consumer genetics or any paternalistic over-reach. Mathew Herper has a really great analysis of the stupidity and or hubris that 23andMe showed.  The Global Genes Project has a nice blog on the relationship between Rare diseases and ACA. 

The bad news is that the sequester has set research back years if not decades and may have very well rob a whole generation of scientists of their careers (this author included). Tom Ulrich of Boston Children Hospital has a nice blog on the subject.

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2015 Update: The new interesting initiative is precision medicine in US. I really am proud of the way Global Genes Project is coming along. I was briefly involved when Nicole Boice started the initiative. I look forward seeing how it continues to grow in 2015. I think it does a great job of keeping the conversation on awareness and providing a site to aggregate "best practices" for the Rare disease community. 

I really hope that the continued access to healthcare that we started to see in 2014 continues. The key will be what do we do with the basic information that clinics gather about their rare diseases patients? How do we make that shareable across clinics. This in my opinion will be the key to consistent diagnosis and clear symptons, which will then better inform scientists of which genes contribute to the phenotype. This is the basis of drug discovery and treatments. 

Right now is a real nexus of information due to the convergence of new technologies with "new" fields of studies. Epigenetics is the study of how and why genes get turned, the best analogy is: if the whole genome is the book of life, genes are the words and epigenetics is the sentence, paragraph and chapter structure that gives the words meaning. The other area is off-shoot of stem cell research; induced pluripotent stem cells (iPSCs). iPSCs as the name implies are induced to become stem cells from a variety of other cell types, the most clinically relevant being skin and blood. While the debate rages iPSCs and their value for replacing non-working cells with new ones [regenerative medicine] one thing that is not in doubt is the power of these cells for modeling disease. iPSCs can be made from patient samples and then shared with other researchers. This may seem trivial but the more people looking at the same model the quicker the core problem can be found. If done right the sharing of the iPSCs to researchers who use different techniques (biochemists, molecular biologists, cancer, etc) will provide a 360 degree view of the disease. 

Update 2014: Unfortunately it seems that iPSC research is becoming marred with scandal. The new "most promising" discovering may be "less real" than one would hope.....Paul Knoepler has a blog on the subject. BTW if you have any interest in stem cells you should follow Knoepler's blog he is an excellent writer and a top notch scientist.

Update 2015: I think we are past the really bad period, unfortunately it has also diminished the enthusiasm for iPSCS as models. Although I am not surprised, it has recently been shown that iPSCs form different sub-types of cells based on their tissue of origin (see here for neural and here for heart). This seriously limits the usefulness of iPSCs for drug discovery and would just exacerbate the reproducibility issues that are plaguing science in general but particularly stem cell research. 

Once this happens it's likely that links will be found that can make drug discovery and testing palatable for biotech and big pharma. Drug discovery is expensive but if the community can gather enough information about the molecular and biochemical characteristics of rare diseases then the existing "orphan drugs" can be tested against the characteristics rather than any single disease. 

Update 2015: The orphan drug area is one where we are starting to see movement. The recent announcement by the CF foundation recieving $3.3B for the patent rights to Kalydeco. It is an interesting approach that should be considered by any rare diseases group looking to expand support and the potential therapies for their disease. 

As always the caution is who should get the money, how do you ensure that the cost of the drug to sufferers is appropriate? If the foundation funds the study (in part) do they have an obligation to ensure that the cost of teh therapy be reasonable to the average person?

The elephant in the room is of course paying for all of this. Scientists need to be able to publish to get grants to pay for post docs and reagents. While there is some money available from disease foundations but it doesn't cover all the costs that a lab needs to run. That is the job of the NIH. However their mandate really requires that grants are given out based on WIDE applicability of the research and the grantee's history of research in that area. Unfortunately this model does not serve the rare community very well nor does it foster the wide range of scientific endeavor. There hundreds of examples where a rare disease has lead to unique insight into a biological pathway that was key to some cancer or other disease. 

Update 2014: Rare disease research will survive but we need to start to fast track new funding models that focus on highly innovative projects. We know what hasn't worked we need some research that is different.

Update 2015: Unfortunately I can't say there has been too much movement on this. Frankly scientific funding is horrible right now. I think for rare disease foundations there is an opportunity to foster young scientists to be advocates and invested in their disease but this requires a new way of thinking about how to fund rather then WHAT to fund.