IT training info tech for health khotailieu

Andrew OramThe Information Technology Fix for Health Barriers and Pathways to the Use of Information Technology for Better Health Care... 1 Barriers and Pathways to the Use of Informatio

Make Data Work

strataconf.com

Presented by O’Reilly and Cloudera, Strata + Hadoop World is where cutting-edge data science and new business fundamentals intersect— and merge.

n Learn business applications of data technologies

nDevelop new skills through trainings and in-depth tutorials

nConnect with an international community of thousands who work with data

Job # 15420

Andrew Oram

The Information Technology Fix for Health

Barriers and Pathways to the Use of Information Technology for Better

Health Care

The Information Technology Fix for Health

by Andrew Oram

Copyright © 2014 O’Reilly Media, Inc All rights reserved.

Printed in the United States of America.

Published by O’Reilly Media, Inc., 1005 Gravenstein Highway North, Sebastopol, CA 95472.

O’Reilly books may be purchased for educational, business, or sales promotional use.

Online editions are also available for most titles (http://my.safaribooksonline.com) For

more information, contact our corporate/institutional sales department: 800-998-9938

or corporate@oreilly.com.

March 2014: First Edition

Revision History for the First Edition:

While every precaution has been taken in the preparation of this book, the publisher and author assume no responsibility for errors or omissions, or for damages resulting from the use of the information contained herein.

ISBN: 978-1-491-90241-7

[LSI]

Table of Contents

The Information Technology Fix for Health 1

Barriers and Pathways to the Use of Information Technology for Better Health Care 1

Devices, Sensors, and Patient Monitoring 5

Digital Building Blocks of a Health Plan 5

Environmental Sensors: Where Do You Feel the Pain? 7

Barriers to Devices and Sensors 7

Using Data: Records, Public Data Sets, and Research 10

Electronic Health Record Systems 11

Public Data Sets 21

Medical Coding Standards 22

Reframing Clinical Research 23

Barriers to Using Data 25

Coordinated Care: Teams and Telehealth 29

Health Information Exchanges 34

Accountable Care Organizations and Other Integrated Care 36

Telehealth 39

Barriers to Coordinated Care 40

Patient Empowerment 41

Health Care Without a Doctor 42

Gamification 42

Transparency 43

Patient Control Over Data 44

General Closing Thoughts 46

iii

The Information Technology Fix

for Health

Barriers and Pathways to the Use of

Information Technology for Better Health Care

A constellation of new health-related activities and technologies, va‐lidated by clinical research and starting to roll out into medical prac‐tice, holds the promise of better health for everyone These activitiesexploit the astonishing miniaturization of ever-more powerful devi‐ces, along with the collection, analysis, and sharing of data, to supportbetter coordination and delivery of health care Interest in these in‐novations is driven by the health care system’s pressing need to:

• Control chronic illnesses such as diabetes and hypertension toprevent progression and complications

• Find more effective and less intrusive treatments for a range ofdiseases, and do so faster

• Lower system-wide costs, or at least staunch the rate of increase

• Reduce medical errors and misdiagnoses

• Improve patients’ sense of control over their care and their destiny

• Ease stress on practitioners and caregivers

• Sweep away some of the administrative and bureaucratic loadWhat are the promises of the new technologies, and what conditionshave to be in place to enjoy those benefits? Why do some technologiesseem to languish despite their apparent advantages? How do all these

1

things depend on each other, and what technologies and activities need

to be adopted in tandem?

The large trends in these groundbreaking approaches—as well as thethings that stand in their way—form the subjects of this article It isnot a catalog of applications or technologies, but a broad investigation

of their potential I hope that the themes herein come home to severaltypes of diverse readers:

• Anyone with a career in medicine and the enormous health careindustries will see big changes in the field The health care indus‐tries aren’t likely to shrink dramatically or be disintermediated ashave travel agents, bookstores, many newspapers, or much of themusic recording industry, but some of their functions will disap‐pear while others leap into the twenty-first century The technol‐ogies discussed here will be implicated in these disruptions

• Computer experts, data scientists, and other hi-tech professionalswill stream into health care, where they will stumble upon veryunusual activities and norms

• Professionals in public health and health care policy will want tounderstand the potential the technology holds to affect treatmentsand costs, and to maintain a clear-sighted view of the problemsthat crop up when applying the technologies Problems are un‐known to or underestimated by some observers, while beingshaken vigorously in our faces by others to block the deployment

of useful technologies

• People concerned about the economic future of nearly any coun‐try in the world should worry about the exploding costs of healthcare These are being driven by aging populations as well as newdiagnostic techniques and treatments that provide astonishingadvances in extending human life, but at great expense, and areexacerbated by inefficient business and clinical processes, lack ofinformation liquidity, and overlapping, sometimes contradictoryregulatory demands Smart health technologies, including patientengagement, could help those increases to level off

• Everybody will feel the shift Your interactions with this newhealth care system (and for the first time, we might really be able

to ennoble our grab-bag of medical practices and technologies bycalling them a “system”) will differ depending on whether you areyoung or old, live in a city or the country, are (currently) healthy

or chronically ill—but the interaction will be very different fromwhat most people have now.

What are some of the technological changes coming over the horizon?

• Sensors are checking how elderly residents move around theirhomes, and registering signs of inactivity that may indicate illhealth or atypical patterns suggesting disorientation

• Behavioral conditions are being treated with the help of games,some of which produce lasting improvements such as promotingadaptation in victims of PTSD, and instilling control in peoplewith ADHD by presenting tasks and then throwing distractions

at the player

• Large-scale data analysis of patient reactions to marketed drugsare turning up adverse effects not found during clinical trials, andprompting reconsideration of the sterling trust placed in conven‐tional trials

• Electronic record exchange is allowing patients to walk into ahospital hundreds of miles from where they have previously beentreated and offer unfamiliar doctors complete medical histories,including key information such as drug allergies

• Mobile phones are allowing people in isolated rural areas, even indeveloping nations, to snap photos of medical problems or evenmeasure vital signs and get advice from remote doctors

• Researchers are starting to release not only articles about theirresearch, but also the underlying data used to reach their conclu‐sions, allowing other researchers to check their work, duplicatestudies, and combine the data from multiple experiments.Technology is always just a tool, whose use rises, falls, and meta‐morphizes through its relation to the people and organizations thatuse it Technology also introduces risks whose effects in medicine canweaken the doctor/patient relationship and cause life-threatening er‐rors Although this article does not delve into social policy or organ‐izational change, I’ll look at some of the impacts these have on thetechnologies, and vice versa

Health reformer Arien Malec delineated (in a video-taped presenta‐tion) the tension between technology and the personal touch In ear‐lier ages of medicine we enjoyed a personal relationship with a doctorwho knew everything about us and our families—but who couldn’t

Barriers and Pathways to the Use of Information Technology for Better Health Care | 3

actually do much for us for lack of effective treatments Beginning withthe breakthroughs in manufacturing antibiotics and the mass vacci‐nation programs of the mid-twentieth century, medicine has becomeincreasingly effective but increasingly impersonal Now we have med‐icines and machinery that would awe earlier generations, but we rarelydevelop the relationships that can help us overcome chronicconditions.

Health IT can restore the balance, allowing us to make better use oftreatments while creating beneficial relationships Ideally, health ITwould bring the collective intelligence of the entire medical industryinto the patient/clinician relationship and inform their decisions—butwould do so in such a natural way that both patient and clinician wouldfeel like it wasn’t there

This article takes a tour through specific technologies, tools, andtrends to see what has really been accomplished and what is feasible

in the near future:

Devices, sensors, and patient monitoring

We start our journey with information technology that lies rightnext to our bodies, and sometimes even inside them This sectiondiscusses how things we touch, hold, and wear, along with ourconcern for fitness in daily life, can become part of formal healthtreatment

Using data: records, public data sets, and research

The use of computers, including the devices from the previoussection, revolves around data Here we turn to an area of infor‐mation technology that is somewhat hidden away but will proveabsolutely crucial to health care: understanding ourselves throughdata about ourselves and our institutions This must be collected,stored, sent between health care sites, and used to find bettertreatments

Coordinated care: teams and telehealth

Fortified by the background in the previous two sections, we canproceed to changes taking place in treatment settings, includingnew ways of structuring teams and even sets of health care insti‐tutions, and where these institutions need to draw on the tech‐nologies discussed in the article

Patient empowerment

People stand front and center throughout this survey of technol‐ogy The article will culminate in the empowerment that infor‐mation technology offers people on their own or when engagingwith the health care establishment

Devices, Sensors, and Patient Monitoring

When many people think of medical devices, enormous clanking ma‐chines that might cost a million dollars or more come to mind (such

as for radiology, MRIs, CT scans, or lab analysis) The output fromthese devices tends to pass through labs, radiologists, or other medicaloracles while the patient chews her fingernails and waits several daysfor results But as in other technologies, miniaturization is transform‐ing medical equipment Lots of small devices are already in use, withpacemakers and other cardio implants bringing dramatic improve‐ments to quality of life Other devices bring health data into the hands

of ordinary people—even turning up in smartphones

Digital Building Blocks of a Health Plan

Attendees at the high-profile Consumer Electronics Show at the be‐ginning of 2014 lost themselves in a sea of personal monitoring devi‐ces Whether or not these early consumer devices take off, self-monitoring is on the verge of becoming mainstream, with the use ofapps expected to expand rapidly Gadgets marketed to consumers canbypass many of the barriers to development, regulatory approval, andmarketing that currently keep devices expensive and focused on a sin‐gle task

Technologies supporting the Quantified Self movement include thefollowing:

• Fitbits and other wearable measurement devices are surging inpopularity Just walk through a consumer electronics store to seehow widespread and available these devices are Many measurenot only activity, but also health-related vital signs such as pulse,blood pressure, and oxygen consumption

• Devices are becoming easier and friendlier to use For instance,the HeartCheck Pen is a small, pen-sized device that takes readingsfrom the thumbs when pressed onto the sensor pads—a device ofpotential value to people at risk for stroke and heart attacks The

Devices, Sensors, and Patient Monitoring | 5

Nymi is a bracelet that measures one’s ECG from the wrist andfingertip Diabetes patients need to measure glucose levels fre‐quently and manage insulin dosing to prevent hyperglycemiccomplications and avoid hypoglycemic episodes, so noninvasivemeasurement devices now avoid the need for frequent skinpricks—one such device is embedded in a contact lens Althoughcurrently positioned only as an authentication technology (a se‐curity device to replace passwords), the possible medical applica‐tions of a mobile device that measures ECG for things such ascardiac disease monitoring are exciting.

• Wristbands and finger clips may soon seem quaintly awkward,with even greater miniaturization on the way Reductions in sizedemocratize medicine in many ways: by lowering the costs of de‐vices, by making them more attractive and comfortable (a criticalconsideration for widespread adoption), and by reducing powerrequirements For example, sensors warning of concussions can

be worn under sports helmets or embedded directly in them, al‐though their accuracy is disputed

• Sensors embedded in pill containers can notify doctors when thepatients have taken their medication This can help clinicians re‐mind patients and encourage medication adherence, which is amajor problem in maintaining health because so many patientsforget their pills or need urging to adhere to their regimens Ifsmart packaging sounds like science fiction, just consider inges‐tible pills that work together with a body patch and a smartphone

to signal when they’re digested

• A chip small enough to be sent through blood vessels returns ul‐trasound measurements of the vessels or the heart Researchersexpect to shrink it further

• Robots can be seen increasingly roaming the hospital corridors,and will eventually turn up in nursing care facilities and even thehome as well

People use personal devices to measure improvements in personalgoals and bolster their determination to achieve even more (although

as we will see, most of the devices and apps are not used for very long).Devices also connect people with others engaged in fitness programsand form communities for support

Although some people can benefit individually from reading and in‐terpreting the displays on their devices, the data is most valuable when

inserted into a patient record and combined with data from otherusers In a patient record, the data can be checked by clinical expertsand be mined for trends Combining data from many users enablessuch benefits such as finding out where they stand relative to the pop‐ulation as a whole Are you better or worse off than the norm? Areyour vital signs in a danger zone?

Environmental Sensors: Where Do You Feel the Pain?

With mobile phones and dedicated consumer devices to support thequest for health, the trend today is to manage chronic conditions, thedifficulties of aging, and recovery from traumatic events andsurgery—really, anything that benefits from close attention byclinicians—in the environments where the patients spend their time.And what could make more sense? After all, the patient’s symptomsoccur in the environment where he spends his time The Institute forthe Future writes, “Health care is moving from an acute, episodic caremodel to a more continuous, chronic care model” (page 7 of the pa‐per) That paper also lays out the move from the professional setting

to the patient’s environment, and the crucial role that will be played

by mobile devices and sensors in the hands of patients

Dueling trends are at work as devices bring the clinic into the home

On the one hand, consumer devices are unfolding the vision expressed

by health IT leader Samir Damani: “We are really moving from adoctor-centric society to a patient-centric society.” On the other hand,sensors can be scary and intrusive Obviously, consumers will rebelagainst monitoring unless their privacy is respected and they feel likepartners are improving their own health with the support of the clini‐cian and technology

The home is not the only place that can join the clinic and the hospital

as health settings—other important places in people’s lives, such as

schools and workplaces, can as well Public interest in health toolsoutside clinical settings is growing worldwide

Barriers to Devices and Sensors

In addition to personal or cultural aversion, the barriers that hold backadoption of sensor technologies include the following:

it’s safe and works better than a placebo Small devices presentfewer headaches than drugs because any safety problems they poseare likely to be concrete and obvious Clinical trials for devices aremuch simpler than drug trials for a host of reasons, ranging fromthe high failure rate of new chemical compounds to the morestraightforward safety considerations of external devices.Still, to line up people with the right combination of medical con‐ditions, ensure they follow instructions, and measure effects (es‐pecially over a long time period) is a big job Given so many com‐peting, poorly-tested apps, most fail to appeal to users or to beparticularly effective Few are downloaded by a lot of people (forinstance, only 1.2% of the smartphone-enabled diabetes popula‐tion uses apps), and far fewer are used over a long period of time.This resistance holds back market penetration, makes it hard togather statistically significant measures of their efficacy, anddampens investors’ incentive to improve products.

Although most manufacturers of the current generation of con‐sumer devices are careful to label them for “fitness” rather than

“health,” there is a point where their use can trespass onto therealm regulated by government The FDA has even declared ju‐risdiction over mobile phone apps that have clear medical pur‐poses and has reviewed more than 100 such apps, although theagency is doing its best to keep its hands off popular devices andapps for casual use Its regulatory jurisdiction extends over devicesused for diagnosis or treatment of specific medical conditions, nothealth in general

Cost

If we can save lives and avoid emergency room visits or othercostly treatments, a medical device comes cheap at almost anyprice FDA-approved cardiac devices and other implants have es‐tablished themselves as cost-effective But no one can guaranteethat the emerging generation of consumer and patient devicesreally does what people fervently hope them to do In the mean‐time, most people (and their insurers) still think twice beforebuying a gadget of unclear value

Data quality

Different devices can report different measurements, raising sus‐picions about their trustworthiness Each device may produce in‐formation that’s useful in a relative sense (i.e., how much the value

goes up and down over time) but perhaps not useful in its absolutevalues.

Simplicity

Consumers who are content to spend days setting up a home en‐tertainment center seem to lose patience when it comes to devicesthat improve their health If the interface is more than a singlebutton, many will give up at the start Simplicity must also be therule in displays It’s particularly important for the elderly (who didnot grow up with ubiquitous computer technology) and for any‐one injured or impaired (chemotherapy and dementia are just two

of the burdens that affect one’s ability to remember and followtechnical instructions)

Overmeasurement

People can get compulsive when measuring themselves, and over‐interpret arbitrary changes that take place day to day or hour tohour Measuring your blood pressure can raise your blood pres‐sure! Throwing data into a bucket doesn’t improve our knowledge;

we should determine our goals first and then collect the data that

we can process to help reach the goals

Integration with records

Before data can enter patient records, systems must be designed

to gather well-structured patient data, and appropriate privacyand security controls must be in place Few electronic healthsystems currently accept data directly from patients, who still fillout paper forms to be entered by clerks into electronic formats.Furthermore, patients will be tempted to falsify data under somecircumstances (such as to earn the incentives dangled by employeereward programs), so there must be technical measures to preventtampering with device output Some clinicians mistrust patient-

Devices, Sensors, and Patient Monitoring | 9

generated data, even though most of the information in clinicalinterviews comes from patients anyway.

An Endeavour Partners white paper found that one-third of peoplewho buy wearable devices give them up within six months, and halfwithin two years (page 4) This is not necessarily bad: perhaps the usersfelt that their use of the devices during that short period was sufficient

to meet their goals, such as losing weight or establishing a regularexercise routine But in the quest for long-term use, the white paperproposes nine criteria that could bond users to their fitness devices

In addition to psychological factors such as attractiveness, ease of use,and reinforcing the user’s goals, the white paper urges the provision

of an API so that data from devices can be integrated

Self-tracking is certainly taking off According to a Pew report, 69%

of Americans track some aspect of health for themselves or a lovedone (although usually without digital devices), and 63% of trackersbelieve it has had some positive effect Whether or not tracking wasreally responsible for the change, believing that it does is a goodenough reason to do it The huge base of Quantified Selfers can giveresearchers crucial data to isolate the factors that work most often.Device manufacturers can then base their designs on factors known

to be effective, and demonstrate the value of the devices Finally, themore these devices interoperate and support the integration of theirdata, the more they can contribute to the larger health system Thissystem includes the records that will store the data and the researchthat will mine its insights

Using Data: Records, Public Data Sets,

and Research

Just as we don’t think often about the electrons coursing through most

of the tools we use in twenty-first-century life (until the bars on ourscreen shrink to an alarming low), we don’t often notice the data thatconnects us For medical devices, data is paramount because it’s what

we want from the devices in the first place Data injects power through‐out the rest of the health care system

This section will look first at how data is gathered, stored, and ana‐lyzed, then at the use of open data sets and the role of shared data inclinical research All of these initiatives potentially improve healththrough shared data and its analysis

Electronic Health Record Systems

Walking into clinics where the staff carry around paper records makesyou feel like you caught an old 1930s movie and should be seeing thescene in black and white Recently, superficial signs of progress havetaken hold Policy makers in the United States boast about the in‐creasing adoption of electronic records, particularly since the roll-out

of Meaningful Use incentives in 2009 But don’t jump to conclusionsabout the capabilities of new electronic systems: many are harder touse than the paper records they replace, and barely more useful fordata sharing and analysis

In the United States, virtually every doctor uses electronic records andexchange for billing, because money is the lifeblood of both the healthpractices and the payers But other activities, even something as basic

as ordering a prescription from a pharmacy, are done manually.When clinical patient records do get digitized, they remain what onedoctor called an “electronic file cabinet,” separate from all the work ofplanning and executing care This article will refer to such documents

as an electronic health record (or EHR), because that term is compactand commonly heard But we must really think of patient records as

a critical component of an entire health system that involves a se‐quence of events with each patient, along with analytics that set thedirection of whole collections of clinics and hospitals And one ques‐tion running through this article is how health institutions can use theEHR more effectively throughout their operation to support what re‐formers like to call a learning health care system

In other day-to-day activities, we’re used to making orders online andpreserving data electronically The same kinds of benefits come fromelectronic records: easier appointments, expedited drug orders andrefills, faster billing and reimbursement, etc

Looking beyond convenience is the promise of clinical decision sup‐port (CDS) Doctors can’t keep in their prefrontal cortexes all the in‐formation they need to suggest accurate diagnoses and treatments—even the doctors (grudgingly) admit that, which is why specialists andconsultations exist How can electronic records augment clinicians’intelligence?

• At the most basic level, record systems emit alerts to warn clini‐cians of actions they propose that are inconsistent with the data

in the records, such as when a patient has an allergy to a

Using Data: Records, Public Data Sets, and Research | 11

medication or the dose seems wrong Alerts, from cardiac moni‐tors, intravenous delivery devices, and other equipment attached

to patients are aimed at nursing staff (and sometimes drive them

to distraction, literally)

• Electronic records also prompt diagnostic and reimbursementcodes, and suggest drugs appropriate to the data entered aboutdiseases Unfortunately, electronic systems have not proven able

to do this reliably The Insurance Institute for HIT Safety writes,

“CDS appears to pose a slew of medical legal risks…while offeringfew—if any—protections.”

• The cutting edge of computer support can be seen in experimentalsoftware that generates diagnoses when fed patient histories Such

“expert systems” were tried in medicine as far back as the 1980s,but fizzled out in the face of limitations in hardware power, speed,and memory as well as the lack of flexible database technology.With the enormous speed-up in computing and the rebirth ofartificial intelligence in the twenty-first century, researchers are

trying again to see whether the doctor can be rendered superflu‐ous IBM’s Watson, which they started to commercialize in Janu‐ary 2014, famously proved that natural language analysis canbring to the surface multiple plausible diagnoses for doctors tochoose from But we should take predictions about the obsoles‐cence of the doctor with a grain of salt

• A digital health system can help the staff intervene with patients,through such simple measures as reminding them to schedule andcome to follow-up visits These sorts of interventions can reducethe risk of hospitalization among high-risk patients, such as thosesuffering from diabetes This is a clear example of technology thatsupports, instead of interfering with, the relationship betweenclinician and patient

• A well-structured record-based system can flag patients at highrisk, telling staff where to concentrate their attention

• A patient web portal can allow clients to make appointments,check results of tests, check for errors in diagnoses or medicationlists, and communicate with the staff for nonurgent questions.This is a fairly obvious application of digital technology in an agewhen most people can schedule car repairs and hotel reservationsthrough websites, but it’s surprising how few clinical practices arecapable of such basic online interaction

• Analysis of large data sets can turn up problems that help agenciesimprove public health They can also reduce costs by helping hos‐pitals identify and prioritize high-risk patients (a process calledpatient stratification) Payers use analytics to define “episodes ofcare” that supposedly encompass all the treatment a patient needsfor a particular problem This in turn lets the payers define howmuch to reimburse health providers for treating various patientswith the same condition.

Some large institutions—notably the Department of Veterans Affairs,with its famous VistA software, and Kaiser Permanente—have his‐torically created relatively well-integrated health systems that supportsophisticated interventions to improve patient health Their achieve‐ments crown long-term processes of integrating multiple hospital sys‐tems around the records and training all their clinicians to takeadvantage of the data tracked by the record systems Institutions can

do this when they shoulder a comprehensive role in patients’ lives,insuring them as well as treating them They represent the kind of all-encompassing, long-lasting coverage that many developed countries

do at a national level, and that we will look at under the topic of ac‐countable care organizations According to one account, Kaiser Per‐manente’s four billion dollar expenditure on electronic health recordspaid off

Most deployments of electronic health records achieve considerablyless, however Most EHR systems follow an old 1980s model of soft‐ware development:

• They are entirely proprietary, although standards (which we’lllook at shortly) have been superimposed and are beginning toallow limited innovation in data sharing and analytics Significantbarriers to entry (through regulatory capture and installed bases)have allowed early entrants in the vendor space to lock in largemarket shares with legacy technologies that are hard for innova‐tors to supplant

• Most systems predate the Web or use rare technologies such asMUMPS (standardized as the M language), with kludgy and limi‐ted workarounds just so that EHRs can meet such basic expecta‐tions as patient portals and access by clinicians on mobile devices.More recent entrants in the EHR space, such as Athenahealth and

Practice Fusion, have chosen to go all-online (Software as a Ser‐vice, or SaaS), providing web-based records They tend to be

Using Data: Records, Public Data Sets, and Research | 13

popular among physicians, but Software as a Service stays in thehands of the software provider and is therefore hard to adapt toindividual health providers’ needs.

• Not being standards-based, existing software is expensive to de‐velop, install, and maintain EHRs’ market has therefore beenlarge institutions with millions of dollars to spend on licenses andmillions more on implementation Until recently, proprietaryEHR vendors have totally bypassed the small community and ru‐ral providers where digital records could tremendously improvecare

• Many existing record systems have been developed to meet theinterests of the hospital and clinic administrators who make outpurchase orders and deal with third-party payers, not the interests

of clinicians who ultimately have to use the system for patient care.The chief purpose of such EHRs is financial rather than clinical.For instance, some of the “clinical decision support” built in tothese systems actually tells doctors how to find the codes that le‐gally maximize the payment for a given course of treatment (atrick called “up-coding”)

• Although digitization has transformed other industries, such asecommerce and finance, by facilitating data exchange, the longproprietary history of EHRs leaves them stubbornly resistant tointeroperability The standards in this area have improved recent‐

ly, as we’ll see later in the article But currently, it is hard even forpatients to obtain their own records, on paper or electronically—

a right enshrined in law through HIPAA

The incentives in the HITECH act, part of the 2008 economic recoveryact, spurred adoption of electronic health record systems But im‐provements in quality through electronic records are more elusive.Although most studies show improvements in care, they turn out to

be small and scattered For instance:

• The Agency for Healthcare Research and Quality (AHRQ) found

some decrease in unnecessary tests, and improvements in pedia‐tric care, particularly around prescriptions But many other areasshowed no improvement, or a statistically insignificant one

• A 2011 article in the Journal of the American Medical InformaticsAssociation also found benefits in medication prescription

• A New England Journal of Medicine article found that electronicrecord systems reduced errors in medication, but no evidence that

it reduced errors in diagnosis

Trying to determine the real impact of electronic health record systems

is an exercise in frustration Until recently, most studies were unrep‐resentative of most EHR use, being based on a few leading institutions

or home-grown systems instead of commercially sold systems (seepages 9–11 of this review paper)

It should also be noted that, when trying to measure relative successesand failures, researchers usually define “quality” as how well doctorsadhere to recommended standards of care This is an understandablemetric to settle on, because standards of care are precisely defined Itwould be much harder to measure how much patients actually im‐proved But this choice leaves a gap between what “quality” means inclinical research and the “rather simple statement” from the landmark

Institute of Medicine book, Crossing the Quality Chasm: A New Health

System (page 44): “The ultimate test of the quality of a health caresystem is whether it helps the people it intends to help.”

The designers of the HITECH act knew that adoption of a technologydoes not guarantee effective exploitation of the technology’s benefits;that’s why their reimbursement program was labeled Meaningful Use

in a top-down attempt to improve the way physicians use records.EHR systems, unfortunately, can be habit-forming whether or not theyprovide the expected benefits Institutions that adopt the systems soonfind themselves locked in, their data having entered a cryptic formatunderstood only by the vendor, so that data cannot be retrieved tomove it to a different system When the systems are ill-suited tomodern habits (such as mobile access) or to new needs such as datasharing, institutions find a transition prohibitively expensive anddisruptive

So the US medical industry, under the guidance of the federal gov‐ernment, is taking on a huge collective risk: that EHRs promisingMeaningful Use may fail to meet the new requirements, such as dataexchange, during the day-to-day knocking about they receive (even ifthey are certified as Meaningful Use compliant) Thousands of newhealth practices adopting the EHRs would then join the earlier adopt‐ers as fellow prisoners

Using Data: Records, Public Data Sets, and Research | 15

Electronic record systems definitely improve safety in some ways—such as eliminating confusion in handwritten notes, and displayingwarnings about adverse drug reactions—but can introduce othersources of error The Institute of Medicine (IOM) issued a major

report warning about safety problems in November 2011, the AHRQprepared a report on tracking and assessing risks in electronic healthsystems in May 2012 (a summary of risks appears on page 29), and theOffice of the National Coordinator, which is responsible for adminis‐tering the government’s electronic health record program, released

extensive safety guidelines in January 2014 Besides plain and simplebugs—for which vendors deny liability—problems include thefollowing:

• Confusing interfaces that make it seem that some information wasrecorded when it was not, or the reverse

• Arbitrary restrictions, such as drop-down menus, that leave outthe medications or other choices that the clinician wants to make.Such counterproductive designs can tie up busy doctors and drivethem to enter wrong data

• Records that allow similar information in two or more places, thuscreating such risks as duplicate doses This can certainly happenwith paper records too, but electronic records hide the duplicationbetter and staff are less likely to know that duplicate locationsexist

• Information that is hard to see, perhaps simply because it is out‐side the visible part of the page and the clinician forgets to scrollthe screen

• Arbitrary decisions and defaults that are hard to discern and differ

on each screen

• Overuse of alerts EHRs and hospital devices are programmed toreact crudely to triggers, and manufacturers have set the triggersvery sensitive for fear of missing something important The result

is that a doctor often cannot get through a write-up of a routinevisit without clicking on innumerable dialog boxes to make them

go away; for instance, some systems blindly report every possibleside effect to using a medication Clinicians get used to ignoringthe alerts and ultimately might miss one that they really shouldhave heeded

Although EHRs theoretically allow doctors to customize the alertsthat appear, no one has yet created a truly intelligent alert systemwith acceptable levels both of false negatives (which should bezero) and false positives (which are much too high now) Hospitalwards are as noisy as tropical forests with the sound of beeps in‐stead of animal calls The constant din of multiple competingalerts creates a poor signal-to-noise ratio.

• Images that are distorted or have text overlaid in the wrong places

• Unauthorized sharing of patient data, either intentionally oraccidentally

Like industrial accidents and airplane crashes, medical errors are gen‐erally emergent properties, caused by complex interactions of manyfactors such as haste, misreported symptoms, and plain bad luck Onefactor is often an EHR that gets in the way, hides information behindmultiple clicks, or presents a garbled display Workarounds such as

using sticky notes to store information before entering it in the EHR

lead to more errors

Errors in electronic records also tend to propagate In such cases, one

of the traits that makes them most valuable—data sharing—turns into

a vulnerability And a data breach with EHRs can put millions of pa‐tients at risk in one fell swoop, as front-page news reports regularlyremind us

The reporting requirements that the government and insurers pile on,potentially a boon for patient care and public health, create more workthat is often redundant For instance, stage 1 of Meaningful Use re‐quires the doctor to report whether she checked the hemoglobin A1c

of each diabetic patient In theory, electronic systems should take onmuch of the clerical burden of such reporting requirements Theinformation that the patient has diabetes and that the lab ran a hemo‐globin test is in the record, but current EHR systems do not automat‐ically report it, requiring the doctor instead to do so manually It wouldstrike an observer as odd that such EHR systems could pass certifica‐tion as Meaningful Use compliant, but neither the certification au‐thorities nor the EHR vendors seem to care whether the doctor’s work

is negatively impacted No wonder doctors spend a third of their timewith patients looking at a computer, imperiling their relationshipswith the patients (as we will see later, the core of medicine is therelationship)

Using Data: Records, Public Data Sets, and Research | 17

There’s a movement among doctors for the FDA to regulate electronicrecords in hospitals as medical devices Certainly, the agency has thetools to validate software quality for medical devices, looking at thedevelopment cycle, testing, and other external indicators of softwarequality Nor is the FDA a stranger to software validation: it already

regulates MDDS, which is a type of device that collects, stores, andtransmits data from monitors and other medical devices, and has re‐leased principles of software validation Requirements for EHRs might

be along the lines of those used by NASA to certify critical aerospacesoftware

Proponents claim that similar regulation for electronic medical re‐cords, while increasing costs, will avert life-threatening problems Themost compelling argument against extending regulation to medicalrecords is that the software would have to pass through the validationprocess after every change, slowing updates But if a developmentprocess does not ensure quality, speed becomes a liability A new para‐digm for developing and customizing electronic records is probablymore important than regulation It might consist of the following:

Intense clinician involvement in design

The people using an interface must be part of the design teamthroughout the project, not just brought in as external consultantsintermittently Users who don’t understand IT can collaboratewith IT professionals who don’t understand medicine to createeffective tools, through iterative development and rapid proto‐typing Some people say that the relative success of VistA sprangfrom its genesis among doctors and nurses at the Department ofVeterans Affairs, who did much of their own coding All institu‐tions that are happy with their electronic systems have declaredthat the most crucial factor in their success was bringing in thestaff and making them feel ownership of the transition In fact,making a transition is so time-consuming that it probably exceedsthe costs of the software

Even after products are released, user interfaces must be easier tochange Electronic health records have some of the most notori‐ously user-unfriendly interfaces in the software industry As men‐tioned earlier, the people making purchase decisions are usually

in administrative positions The dissatisfaction that doctors ex‐press about their record systems is legendary Some of the com‐plaints stem from clinicians that are not used to computers (yes,quite a lot of them are in the field), from the urgency and chaos

endemic to many medical environments, or from resistance bystaff toward relinquishing familiar workflows But sometimes therecord system imposes its own rigid workflow without just cause.

An AHRQ study on EHR usability laid out fairly simple require‐ments for tying patient information to treatment plans, butstressed the importance of selecting only the relevant informationand presenting it clearly Too often, neither EHR vendors norinternal IT departments understand what the physicians need tosee and do not respect the value of their time For instance, in‐structions for using software may be printed out as part of thepatient’s record, probably by a programmer who couldn’t tell thedifference between instructions and patient information Suchawkward interfaces drain precious time from the physicians’ andnurses’ days, reducing the time they can spend with patients andcontributing to the serious shortage of physicians that threatensthe hope for universally accessible health care in the United States

More agile systems

Even though every health institution is unique and adapting elec‐tronic records to the enterprise is critical, most record systemsoffer very few customizations It’s useful to allow doctors—as mostrecord systems do—to choose which medications appear on a list

of treatments for a particular condition, and which alerts pop up,but this is a far cry from making the software blend into the office’sworkflow

Serious changes to a product require an investment in certifiedconsultants, additional paid contract work with vendors, or extrademands on overworked internal IT organizations that don’t pos‐sess the expertise to do the job Changes that require vendor actiontake place on the vendor’s schedule A common complaint amongdoctors is that new EHR vendors act responsive and agile withtheir first customers, and then turn just as blank and bureaucratic

as all the older vendors when success and growth come

When local sites do make customizations, they may be swept away

by the next software upgrade When smaller vendors go out ofbusiness or are merged into larger firms, maintenance and techsupport may vanish

Better attention to safety

EHR vendors contractually deny responsibility for errors enteredinto records through bugs or confusing interfaces The health

Using Data: Records, Public Data Sets, and Research | 19

provider, who is presumably able to check for and catch any errors,bears liability for anything that goes wrong with a patient To befair, throughout the computer industry, software manufacturerscommonly assert no warranty for software bugs But the manu‐facturers should compensate by providing transparent, conve‐nient feedback and tracking systems for bugs and productimprovement suggestions.

More transparency

Contracts and vendor responsibilities could be much more bal‐anced and reasonable, as recommended by the American MedicalInformatics Association This includes rights for software users

as basic as discussing defects and the costs of products

Some problems of EHR systems are solved at lower cost through freesoftware Free software or open source EHR systems include

OpenMRS, Tolven, OSCAR, and several variants of VistA, whose de‐velopment is now coordinated by a foundation called OSEHRA VistA

is gaining a bigger installed base, although its penetration is nowherenear what its fame would seem to deserve The Open Health Tools

consortium develops free software for clinical and research use De‐ployments of open source health records in developing nations are

supported by Partners in Health, among others

The low adoption rate for these open source alternatives (at least inthe United States) has been blamed on disparate issues ranging fromsheer prejudice in the health care field to poor marketing A good deal

of this open source software originated in academia or government,and therefore isn’t backed by strong sales or support organizations.VistA’s dependency on MUMPS also dissuades enough potential de‐velopers that MUMPS wrappers have been created for other languages.But at base, the problem may simply be that an EHR system that trulymakes life easy for clinicians has yet to be created

It’s also possible that online, SaaS systems with essentially no admin‐istrative overhead are preempting any interest that might have gone

to open source EHRs But for reasons of security and accountability,

it would be valuable even for the online systems to publish their sourcecode

One of the foundations of innovation consists of public data sets aboutproviders, patients, and communities But these public data sets joinpatients as victims of electronic record systems that capture data and