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Health and Human Services finalizes meaningful use for electronic health records

What event could bring together four major leaders of health care
within the Administration -- Surgeon General Regina Benjamin, Secretary
Kathleen Sebelius of the Department of Health and Human Services,
National Coordinator David Blumenthal, and Donald Berwick, who has
just been sworn in yesterday over the objections of Republican
Congressmen as Administrator of the Center for Medicare &
Medicaid -- for a press conference?

It was the release of the final "meaningful use" criteria for the adoption of electronic health records by doctors' offices and hospitals. This initiative, part of the American Recovery and Reinvestment Act (ARRA), offers several thousand dollars to each health care provider as a motivation for adopting electronic records.

The catch is that they can't just install the electronic system, but
have to demonstrate that they're using it in ways that will improve
patient care, reduce costs, allow different providers to securely
share data, and provide data to government researchers in order to
find better ways to care for patients. That's what "meaningful use"
means.

The recovery act bets a lot of money on the ability of doctors and
hospitals to convert to electronic records--including small and rural
providers whose offices still look a lot like a Norman Rockwell
painting. The pressure on everyone is high, and the rewards are
substantial.

The press conference offered hardly any details about the final rules,
but you can find a summary on the href="http://healthcarereform.nejm.org/?p=3732">web site of the New
England Journal of Medicine. There's now also a href="http://healthit.hhs.gov/meaningfuluse">meaningful use microsite
at the HHS's Health IT site. (You can even get the whole 864
pages as a href="http://www.ofr.gov/OFRUpload/OFRData/2010-17207_PI.pdf">PDF
from the Federal Register or view it in the embedded link further down
this blog.) Experts in the health field are going to put in late
nights figuring out the impacts of the final standards--which are
considerably relaxed from the proposed standards--on health care
providers, and O'Reilly Radar will run a longer article on meaningful
use later this week. Right now I'll focus on areas of interest to
technologists: what elements of digital records will be required to
make use meaningful.

Final meaningful use rule from HHS

Getting data out of electronic systems

To be useful, data has to be fluid. In the case of patient data, it
must be:

All these requirements call for the collection, storage, and sharing
of different combinations of data. They obviously presents security
issues that I won't cover here--let's just start with the basic
problem of getting data out of the electronic systems in which it is
stored.

To say that current commercial health record systems are closed is an
understatement. Doctors have been known to buy the same systems from
the same manufacturers as the hospitals at which they practice, and
still have trouble exchanging certain kinds of data. To exchange
data among entities that have no formal relationship, they have to
hook up with a health information exchange (HIE) and sometimes pay
large sums to do data transfers.

Part of the barrier lies in the security and privacy requirements I
mentioned before, but much of it lies in the incompatible formats used
by manufacturers of electronic systems--even when they claim to follow
the same standards.

A few providers now have APIs. Google Health and Microsoft
HealthVault, which are targeted at patients, have APIs, and a few of
the physician systems (such as href="http://www.practicefusion.com/">Practice Fusion and href="http://www.eclipsys.com/">Eclipsys, to whom I spoke at href="http://radar.oreilly.com/2010/03/report-from-himms-health-it-co-1.html">conference
four months ago) have joined the movement. Some electronic systems
have been enhanced to release data directly to the Google or Microsoft
systems, at the patient request. But most patients still prefer to
leave their records with their doctors. And each API is different.

HHS is doing its best to make sure electronic record systems support
its goals. In parallel with the meaningful use criteria, it has been
developing a system for independent organizations to certify the
electronic records systems. Today, HHS also released an "Initial Set
of Standards, Implementation Specifications, and Certification
Criteria for Electronic Health Record Technology" that lay out their
expectations. Significantly, open source developers are explicitly
encouraged to submit their systems.

Patient copies

A number of the meaningful use criteria deal with giving patients
their own information in electronic form. As the previous section
explained, this is not a trivial requirement. For stage 1, a criterion
of success is that the patient gets the data within three business
days. Most of us will be out of bed and walking by then.

One could well ask how a patient can read the electronic record even
when it's provided--does the patient need the same $15,000-per-seat
system as the hospital to get access to it? Or is the data in an
"open" format, so that the patient must simply be comfortable with an
XML parser?

Structured formats


Health IT at OSCON 2010The criteria speak repeatedly of "structured formats," loosely
described with examples such as "the electronic transmission of orders
entered using computerized provider order entry (CPOE) and the
electronic transmission of diagnostic test results" (p. 35 of the
final rules). People in the computer field, particularly those who are
used to ecommerce systems, may assume that data will be stored in a
database following canonical criteria, but in the health care field
chaos tends to rein.

It's easy for an electronic format to store data in a state just as
unstructured as a hand-scrawled progress note. If data is scanned from
paper or just entered casually into the computer, a free-from text
section may contain critical information the patient's condition and
treatment.

When hospitals do adopt standards, they are are often unsuitable for
the kinds of processing required to answer such basic questions as,
"How many of our patients with diabetes smoke tobacco?" The standards
have evolved over decades, and their ambiguity is compounded by
inconsistent data entry by thousands of people over many years.

To take one example, most hospitals store diagnostic information in
the International
Classification of Diseases, Ninth Revision
, ICD-9. This is href="http://www.ahima.org/icd10/replaced.aspx">replace ICD-9
universally understood to be an inadequate format--lacking in
detail, ambiguous, hard to parse--but it will take years to adopt1 the
much superior href="http://www.ahima.org/icd10/understanding.aspx">ICD-10 and
migrate existing records.

Similar evolution and mismatches take place in every aspect of patient
records: medications, allergies, etc. I don't want to present a
hopeless scenario, because some data is actually in good, helpful
formats, such as lab results. But the most established formats are the
codes used by physicians to bill insurance companies, because those
companies demand the codes. We'll see the results of this
standardization a bit later.

Decision support

Electronic systems can facilitate immense improvements in patient
care. A simple procedure such as giving each patient a bar-code and
checking that code before administering medicine can prevent medicines
from being given to the wrong patient.

The meaningful use criteria mention several quality and decision
support issues, such as href="http://www.psnet.ahrq.gov/primer.aspx?primerID=1">medication
reconciliation, which ensures that a patient continues getting the
meds she needs after going from the hospital to the rehab facility or
some other transition. Similarly, clinicians will have to start
reporting data to the government on three core quality measures in
2011: blood-pressure level, tobacco status, and adult weight
screening.

But this is sad case of garbage in, garbage out. For instance, doctors
often shoehorn their patients' conditions into bizarre codes in order
to get payment from the insurance companies. This is not fraud, but
simply playing the game the way the insurers want it. But if a
researcher tries to draw clinically relevant conclusions from these
diagnoses, the results are ludicrous.

One researcher in the health care field told me that researchers never
use the standard formats found in electronic record systems for
research, because they don't fit. Each researcher invents his or her
own ad hoc format, and doesn't spend much time on the task because
they're in a rush to process the data. This is a lot of reinventing
the wheel, and makes data sharing more difficult.

I think data reporting is great, but government departments have to
establish formats and manufacturers have to honor them. This will no
doubt be part of the certification process to designate health record
systems as suitable for meaningful use.

Making a dream come true

In her introduction to today's press conference, Secretary Sebelius
said that doctors who implement electronic records tell her they
"can't imagine practicing health any other way." Her words were echoed
by ONC chair Blumenthal. What I've heard in the field is a good deal
different.

Many doctors have spent enormous amounts of money installing
electronic systems and converting parper records, only to find no
increase in efficiency. In fact, studies have questioned the value of
using existing systems. No doubt one has to expect a loss of
efficiency during the conversion and training period, and most of the
blame for poor results lie in doctors' workflows rather than the
electronic products. As administrator Berwick said today, moving From
paper to electronic records requires a "new culture." In any case,
satisfaction is by no means guaranteed.

Meaningful use is the answer to that problem. It is supposed to make
doctors conscious of the steps they need to take to get the benefits
promised by electronic records. HHS has devoted considerable effort to
choosing criteria that can really make a difference, and to tweaking
the implementation schedule to strike a balance between the need to
give providers a push and the need to recognize that change is
hard. On the side of the technologies, the issues described in this
blog will have to be solved to reach our goal.

Later this week a longer article will appear on Radar about the implications of the final meaningful use rules and their effects in clinical environments.

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