Ready or Not Electronic Health Records are Coming

The games afoot or as they say in England "Game on".....healthcare standards are published (actually the Notice of Proposed Rule Making NPRM - which can be found here) and supplemented by an article posted by David Blumenthal "Launching HITECH" posted by the New England Journal of Medicine.

As before there are multiple stages that include incentives linked to each of the stages but if we focus on Stage 1 that starts in 2011. This includes electronically capturing health information, clinical decision support for disease and medication management, clinical quality measures all tied with protection and securing of the information (don't forget liability for security breaches is now much further reaching). The investment is made (numbers vary but range from $14 - 27 Billion). To receive incentives providers must use their electronic medical records to improve the overall quality of healthcare delivered by demonstrating achievement of a series of objectives. These include (this is not an exhaustive list but captures the main elements):

• Entering orders, medications etc in CPOE
• Maintaining problem lists in ICD9-CM or Snomed-CT coding
• Maintain active medication list and electronic prescribing
• Recording vital signs, smoking status
• Receive and display lab results encoded with LOINC codes
• Generate patient lists based on specific conditions and generate patient reminders
• Provide patients with electronic copy and electronic access to their record and discharge instructions
• Generate a clinical summary for each visit
• Exchange clinical data with other providers
• Protect the information, encrypt it and record disclosures

There are others but these are broad categories and groups and represent a major push to genuine electronic medical records that are digital, contain useful data and are shareable between systems. Certification (as currently provided by CCHIT based on their existing criteria and what we know to date about the requirements for meaningful use) has 11 products certified for 2011 - list here. This is a work in progress and expect to see many more and probably other certification bodies.

The overall tenet of this initiative is summarized by Dr Blumenthal in his article:

...so as to reward the meaningful use of qualified, certified EHRs — an innovative and powerful concept. By focusing on the effective use of EHRs with certain capabilities, the HITECH Act makes clear that the adoption of records is not a sufficient purpose: it is the use of EHRs to achieve health and efficiency goals that matters.

There are other strands/programs that are designed to address the obstacles to adoption - summarized in this chart from the NEJM article:




Behind the scenes the health information exchanges that allow for the easy sharing of clinical data between systems, clinical users and patients will be essential.

This is a broad set of criteria and for many clinical practices a long way from where they are now. The shape of this program is clear - sign up and participate now and receive additional funding/payment or wait and be punished later if you do not implement. There remain many challenges not least of all the products and expertise required to roll these technologies out but to me the message is clear - this train is leaving and failing to get on board will will cost you more in the future.

In the first instance we have an opportunity top provide input to the NPRM - the link for this can be found on the main page of the HHS HealthIT page here or the actual system here. Have you managed to wade through the 600+ pages or found a great summary of the content highlighting key aspects - share the knowledge, leave a comment with your thoughts and/or links and help everyone get up to speed with this material and provide input to the rule by the end of February 2010.

Cause and Effect - Unintended Consequences

It was the story of the story of the Indiana Grandmother of Triplets whose picture ended up on the front page of her local newspaper titled "Drug Sweep" for the crime of buying two boxes Cold medication that got me thinking about the effect each of us has and fail to realize. She was arrested and prosecuted by the local Prosecutor (Nina Alexander) :

The public has the responsibility to know what is legal and what is not, and ignorance of the law is no excuse

whose inability to see past rules and regulations and direct transference of the problem directly to "the customer". As James Shott writes in Observations in his piece "Citizens deserve service from Lawmakers" the prosecutor clearly lost site of who precisely she was serving:

But does the public not also have a reasonable expectation that laws will be rational and bureaucrats will use common sense?

It would appear not in this case nor in this case. Working the other way was the surprise to the prison authorities in the United Kingdom who introduced anti bacterial hand gel pumps but quickly withdrew them when they discovered inmates were drinking the gel: "HM Prisons ban Anti Bacterial Hand Gel" - interesting they also mention the Royal Bournemouth Hospital was having the same problem and said:

it was one of many hospitals removing alcohol-based hand cleaning gel from reception areas in a bid to stop visitors drinking it

Who would have thought it!

But the same is true with money focused on healthcare reform already approved which according to Mark Leavitt from CCHIT and his presentation at AHIMA last week amounts to $36 Billion. As Kelly Mclendon from HIXPerts pointed out in his presentation this proposals are no longer proposals and the regulation went into effect September 23, 2009 (enforcement may be delayed but it's coming) with a series of focus areas:

• Incentives Meaningful Use and Certified EHR's
• Workforce Expansion
• HIPAA - Privacy and Security
• Data Exchange
• Regional Centers (CER)

As quoted in the presentation - the Office of the National Coordinator (ONC) said on Meaningful use:

To some providers, particularly small or already stretched physician practices or small, rural hospitals, the path toward meaningful use may still seem arduous. To others, who would just prefer to stick with the "status quo," it may seem like an unwanted intrusion. We believe that the time has come for coordinated action. The price of inaction – in adverse events, lost patient lives, delayed or improper treatments, unnecessary procedures, excessive costs, and so on – is just too high, and will only get worse

This train has left and if you are left in any doubt as to the likelihood of the digitization of medicine is coming - ready or not. In the current documents for certification published on the CCHIT web site (warning pdf: Comprehensive Certification Handbook) a quick search of the for the following terms revealed the following number of hits:

Transcription - 0
Dictation - 0
Narrative - 1 ("Textual narratives must be present in each required section")

And the same in the Document (warning pdf: Meaningful Use Matrix Tagged for CCHIT Reference):

Transcription - 0
Dictation - 0
Narrative - 0

While this is neither scientific or conclusive it does represents the potential for unintended consequences. I wonder how many physicians can imagine their lives without Dictation, Transcription and Narrative. There are studies questioning the effects of technology on healthcare with the widespread implementation. Unfortunately subscription required for full articles - Journal of Biomedical Informatics: Qualitative studies to Improve Usability of EMR) - interference with worklfow as one of the posible challenges. More data continues to emerge that suggests that even for the oft cited "young" physician who grew up in an era awash with technology, computers keyboards still fail to transition easily to documentation using a keyboard and mouse once they enter a busy clinical practice overwhelmed with patients. As the Healthstory consortium states:

Approximately 1.2 billion clinical documents are produced in the United States each year. Dictated and transcribed documents make up around 60% of all clinical notes

With the looming regulations and incentives that currently take very little account of this enormous block of data. In fact in many instances have been promoting how they plan or propose to get rid of it, ostensibly to "save money" offers an opportunity to watch untended consequences grind the system to a halt. Anecdotal stories of physicians who are forced to spend more time on documentation for the purposes of clinical systems and in the case of the NPR story today: How the Modern Patient Drives up Health Costs that featured a tearful Dr Teresa Moore whose Keysville practice is overwhelmed with paperwork that finds her

stay(ing) at her office late into the night, trying to complete paperwork so that she is able to spend enough time with her patients during the day — enough time to explain why this test is probably not necessary, why that pill wouldn't be a good idea. And her children, she says, pay the price

In this story the focus is the additional burden of the educated patient questioning care, asking for alternatives or bringing in internet print outs and adverts. But the principles and issues remain the same - and as she says when asked if she preferred the old passive patient or the newer more demanding modern patient

But I do like an educated patient who's willing to read about their health issues. So I guess I'd like someone in the middle

Having others deal with the burdens of documentation (or in this case insurance that in her words: "Sometimes you have to request a form just to get the correct form — you do. You have to fill out a form stating the preauthorization form that you need") would help alleviate the strains placed on the clinical providers. But without involvement and participation of the providers of clinical documentation services we may be caught up in unintended consequences both from the perspective of the patient but also from an industry.

Be part of the solution and get involved - join Healthstory, get involved in Advocacy and provide input to the Rule Making and definition of Meaningful use.

Digital Medicine Not Fulfilling Promises

The electronic medical record and the digitization of the health care system is entering more main stream media and coverage as evidenced by the article in Business week - "The Dubious Promise of Digital Medicine". As they put it the companies are:

in a stimulus-fueled frenzy, are piling into the business

Neal Patterson from Cerner is quoted likening this to the

19th century land rush that opened his native Oklahoma to homesteaders

If that analogy is correct then much of the activity is individuals and companies tuned to their favorite radio station WIFM...What's in it For Me? There are some interesting quotes including the suggestion from GE that they will "Leapfrog the competition" by not only replacing paper but "guiding doctors to the best, least-costly treatment". Now this is an interesting concept tied to Evidence Based Medicine (EBM) that has been around for centuries dating back even to Greece but has more recently attracted attention given the greater availability of data and the tools to process it. But as the piece highlights this rare consensus in Washington conceals the

checkered history of computerized medical files and (is) drowning out legitimate questions about their effectiveness. Cerner, based in Kansas City, Mo., and other industry leaders are pushing expensive systems with serious shortcomings, some doctors say. The high cost and questionable quality of products currently on the market are important reasons why barely 1 in 50 hospitals has a comprehensive electronic records system, according to a study published in March in the New England Journal of Medicine. Only 17% of physicians use any type of electronic records

In fact the 17% probably over states the actual usage as other reports suggest that while 17% of clinicians have purchased these systems there is a further gap in actual use bringing this down to a lower 7-9% in actual use.

In fact as David Kibbe points out

"Most big health IT projects have been clear disasters. This [digital push] is a microcosm for health-care reform....Will the narrow special interests win out over the public good?"

And nowhere has the challenge and in particular the failures been more apparent than in the UK's National Health Service (NHS) that has spent billions on the NPfIT program but has little to show for it.

But the attraction of large sums of money are hard to avoid, especially in the current economic climate and Allscripts CEO Glen Tullman like many, but perhaps with better access given his established relationship with President Obama, are vying for their share of the cash. McKesson have a slew of lobbyists to push their agenda and "building on existing technologies". Epic inevitably promotes the one system from one vendor with the corresponding price tag.

But implementation of these systems remains a challenge and the paper from 2005 in the Journal of the American Medical Association: Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors (abstract here - full article requires subscription) linked errors not to fatigue but to the order entry system. Many subsequent studies support this and even suggest that once the error is introduced these systems have a tremendous effect on perpetuating and proliferating these errors into more health records. The most recent article from the New England Journal of Medicine hammers home the point on the adoption of these systems - "Use of Electronic Records in US Hospitals" (it's available here in full as a pdf) and reports that 1.5% of hospitals have a comprehensive EMR!

So where is this all going - uphill but with multiple interested and vested parties pushing. Part of the push has to come from the users and making these systems intuitive and easy to navigate should be a basic requirement. Requiring days or weeks of training suggests design problems in my mind. Creating interfaces that engineers like does not necessarily translate into a busy clinical setting. Usability, data capture methods and tools and above all workflow optimization that fits into our current future clinical practice will be critical. Just implementing the technology never delivered the value and it has been this historical method that we must recover from and show a smarter more user friendly system.

Anyone should be able to navigate and use an EHR, clinical knowledge resources and these healthcare systems but using them for greatest effect will require more understanding on the part of our current clinicians and support from the plethora of ancillary services and staff who contribute to the functioning healthcare delivery system. To borrow from one of my favorite innovative and error free industries - the airline industry: It is the whole team from design, construction, build, maintenance and ongoing support of airlines that makes the captain do a fantastic job. Take Capt Sully Sullenberger - his actions were truly awe inspiring but without everything around him doing what it was supposed to do and all the hours of training and support he received the outcome might have been very different. As a true hero and consummate professional while accepting praise he has been quick to credit others.

Healthcare is similar and in the old adage - "there is no I in team". We must all do our part in enabling the delivery of high quality healthcare - EMR's and Healthcare IT is one part of that which we do need to get right.