Posts tagged "Policy"

Bipartisan Policy Center’s Health Innovation Initiative: Health IT Industry Officials Lying to Regulators With Impunity?

On Wednesday, February 13, 2013, The Bipartisan Policy Center’s Health Innovation Initiative held a discussion on its new report: An Oversight Framework for Assuring Patient Safety in Health Information Technology.  The announcement is here:  https://bipartisanpolicy.org/news/press-releases/2013/02/bipartisan-policy-center-releases-recommendations-oversight-framework-pa

The report is here (PDF):  “An Oversight Framework for Assuring Patient Safety in Health Information Technology.

The “who’s” of the Bipartisan Policy Center’s Health Innovation Initiative included these people:

  • Senator Tom Daschle, Former U.S. Senate Majority Leader; Co-founder, Bipartisan Policy Center (BPC); and Co-leader BPC Health Project Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research and Quality, Department of Health and Human Services
  • Farzad Mostashari, M.D., ScM, National Coordinator for Health Information Technology, Department of Health and Human Services
  • Peter Angood, M.D., Chief Executive Officer, American College of Physician Executives
  • Russ Branzell, Chief Executive Officer, Colorado Health Medical Group, University of Colorado Health
  • John Glaser, Ph.D., Chief Executive Officer, Siemens Health Services
  • Douglas E. Henley, M.D., FAAFP, Executive Vice President and Chief Executive Officer, American Academy of Family Physicians
  • Jeffrey C. Lerner, Ph.D., President and Chief Executive Officer, ECRI Institute
  • Ed Park, Executive Vice President and Chief Operating Officer, athenahealth
  • Emad Rizk, M.D., President, McKesson Health Solutions
  • Janet Marchibroda, Moderator; Director, BPC Health Innovation Initiative 

Unfortunately, I was unable to attend.  I was at the 2013 Annual Winter Convention of the American Association for Justice (Trial Lawyer’s Association) in Florida, as an invited speaker on health IT risk, its use in evidence tampering, and other legal issues.

“United for Justice” – click to enlarge

I found the following statement from the Bipartisan Policy Center’s Health Innovation Initiative report remarkable as a “framework for health IT safety”:

The Bipartisan Policy Center today proposed an oversight framework for assuring patient safety in health information technology. Among other guiding principles, the framework should be risk-based, flexible and assure patient safety is a shared responsibility, the authors said. “Assuring safety in clinical software in particular is a shared responsibility among developers, implementers, and users across the various stages of the health IT life cycle, which include design and development; implementation and customization; upgrades, maintenance and operations; and risk identification, mitigation and remediation,” the report states. Among other recommendations, the center said clinical software such as electronic health records and software used to inform clinical decision making should be subject to a new oversight framework, rather than traditional regulatory approaches [e.g.,  FDA - ed.] applied to medical devices given its lower risk profile.

I find it remarkable that the health IT industry and its supporters now feel they can lie to our government and regulatory agencies with impunity.  Stating that health IT has a “lower risk profile” is an example.

One cannot know what is acknowledged to be unknown.

From the Institute of Medicine in its 2012 report on health IT safety:

Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care .  Washington, DC: The National Academies Press.

… While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

… More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.” 

Even to those with particularly thick skulls, this statement seems easy to comprehend:

The magnitude of the risk associated with health IT is not known.”

I repeat once again:

One cannot know what is acknowledged to be unknown.

A statement that health IT has a “lower risk profile” compared to other regulated healthcare sectors such as devices or drugs, in order to seek continued and extraordinary regulatory accommodations, is remarkable.  It is either reckless regarding something that the statement’s makers should know, or should have made it their business to know – or a deliberate prevarication with forethought.

The report did attempt to shroud the declarative “lower risk profile” in a sugar coating through misdirection, citing the need to take into account “several factors” including:

“the level of risk of potential patient harm, the degree of direct clinical action on patients, the opportunity for clinician involvement, the nature and pace of its development, and the number of factors beyond the development stage that impact its level of safety in implementation and use.” 

These “factors” speak to a higher level of potential risk, not lower, and are a justification for stronger regulatory oversight, not weaker.  I would opine that there is a possibility that health IT. through which almost all transactions of care need to pass (e.g., orders, results reporting, recording and review of observations, finding, diagnoses, prognoses, treatment plans, etc.), could have a higher risk profile than one-off devices or drugs.  Health IT affects every patient, not just those under a specific therapy or using a specific device or drug.

Partial taxonomies developed from limited data themselves speak to the issue of a potentially huge risk profile of health IT, e.g., the FDA Internal Memo on HIT Risks (link), the AHRQ Hazards Manager taxonomy (link), and the sometimes hair-raising voluntary defects reports (largely from one vendor) in the FDA MAUDE database (link).  Further, health IT can and does affect thousands or tens of thousands of patients en masse even due to one simple defect, such as happened in Rhode Island at Lifespan (link), or due to overall design and implementation problems such as at Contra Costa County, CA (link) and San Francisco’s Dept. of Public Health (link).

We don’t know the true levels of risk and harm – but we need to, and rapidly.  Industry self-policing is not the answer; it didn’t work in drugs and devices, and even with regulation there are still significant problems in those sectors.  (Imagine how it would be if those sectors received the special accommodations that health IT receives, and wishes to continue to receive.)

My other issue is with the “shared responsibility” including “users.”

The user’s responsibility is patient care, not being a beta tester for bug-laden or grossly defective health IT products.  Their responsibility ends at reporting problems without retaliation, and ensuring patient safety.

Their responsibility is to avoid carelessness – as it is when they drive their cars.

In other words, the inclusion of “users” in the statement is superfluous.

It is not a responsibility to be omniscient and be held accountable when bad health IT promotes “use error” (the NIST definition of “use error” I will not repeat again here; search the blog) — as opposed to and as distinct from “user error” – note the final “r” – i.e., carelessness.

Bad health IT (see here):

Bad Health IT (“BHIT”) is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

One special accommodation that the health IT industry has been afforded for far too long is to be able to “blame the user.”

“Blaming the victim” of bad health IT is a more appropriate description.

– SS
Health Care Renewal


Testimony to the HIT Policy Committee

Today I testify to the HIT Policy Committee  and review the HIT Standards Committee responses to the HIT Policy Committee Request for Comment.

Although there are many detailed comments, they stratify into 5 general categories

*Because of the maturity of standards and EHR technology, the Stage 3 goal should be menu set rather than core
*Because of the maturity of workflows, the Stage 3 goal should be a certification requirement (the technology can do it) but not a meaningful use requirement
*Standards do not exist and it is premature to include the goal in Stage 3
*Workflow/experience with production system implementation does not exist and it is premature to include the goal in Stage 3
*We agree with the Policy Committee goal as worded

In general, the Standards Committee applauds the aspirational nature  of many of the goals.    They seem like a reasonable direction.   The challenge is timing.   18 month cycles to design, implement and adopt product require that mature standards exist and pilot workflows have proven efficacy.

I described the caveats raised by the Standards Committee when goals seemed too aspirational for Stage 3.  For example :

*No standards or technologies exist to represent knowledge/rules and enable their automated incorporation into EHR workflows.
*There is no way to electronically broadcast computable guidelines for immunization administration for children into EHR workflows.
*At present there are no standards for contraindications to immunizations
*The is no standard way to electronically broadcast computable guidelines for drug/drug interactions into EHR workflows.
*There is no way to broadcast rules that would create “smart problem lists” such as declaring everyone with a hemoglobin A1c greater than 9 to be a diabetic.
*Incorporating patient generated data into EHRs requires new patient friendly vocabularies and code sets that will map into EHR data structures and protect data integrity.

We agree with many of the goals and believe that progress with Meaningful Use Stage 2 should be extended with higher thresholds which enable organizations and professionals to consolidate our gains.

I am confident that the smart people at ONC will incorporate testimony from stakeholders, the deliberations of the policy committee, and the feedback from the standards committee into a set of go forward recommendations for Meaningful Use stage 3.  

Given that the country is in the midst of ICD-10, Accountable Care/Healthcare Reform implementation, value-based purchasing, Meaningful Use stage 2, and HIPAA revisions, many clinicians, vendors, and IT professionals are feeling overwhelmed.   If Meaningful Use Stage 3 follows existing timelines and focuses on a few key domains, raising the thresholds on existing criteria and incorporating more interoperability where standards are mature, we’ll achieve a balance of benefit and burden.
Life as a Healthcare CIO


Health IT at the National Health Policy Conference

There was an excellent panel at the AcademyHealth National Health Policy Conference held February 4, 2013. First, Secretary Sebelius discussed the administration’s health care policy priorities as key provisions of the Affordable Care Act come online over the next year. The health IT panelists included:

  • Farzad Mostashari, Office of the National Coordinator for Health Information Technology
  • David Blumenthal, The Commonwealth Fund
  • Paul Tang, Palo Alto Medical Foundation
  • Christine Bechtel, National Partnership for Women & Families

You can view the video from the event on C-SPAN HERE.

Dr. Mostashari outlined the ONC’s three goals for creating better interoperability among providers for EHRs:

  • Develop specific technology standards for vendors to agree to in their EHR products
  • Outline reasons why providers need to be able to transfer information between practices, and in which circumstances information can be shared
  • Establish trust among patients that they will be able to obtain their information and that it won’t be breached by others

“There have to be standards that you can reach or that the different vendors can agree to for being able to exchange complex information,” Mostashari said.

Text of Secretary Sebelius speech:

Thank you, Lisa. I want to start by acknowledging our host, Academy Health. America’s health services researchers play an invaluable role in our efforts to build a more effective health care system and a healthier America.

You’re the ones who tell us where the need is greatest, which approaches are working, and when we need to go back to the drawing board. The foundation of a 21st century health care system in this country is going to be the evidence base that you’ve assembled.

I also wanted to specially acknowledge a leader who has done so much to advance health services research over the last few decades. As some of you know, Carolyn Clancy has announced that she will be leaving our department after 23 years at AHRQ, including the last ten as Director.

Carolyn’s record of accomplishment speaks for itself. She’s run AHRQ at a time when its profile has never been higher and demand for its insights has never been greater.

Under her leadership, AHRQ produced its first-ever annual reports on quality, safety, and disparities, finally giving us important benchmarks we can use to track our progress. And AHRQ-funded research has led directly to significant improvements in health outcomes in areas like health care-associated infections.

Carolyn has generously agreed to stay on until we find someone to fill her position. But today, I just want to say – on behalf of the department and millions of Americans benefitting from better, safer care – how grateful we are for her service. Thank you, Carolyn.

The last time I spoke at this conference was in 2010, a few weeks before the passage of the Affordable Care Act. Think about how far we’ve come since then.

When it comes to health insurance, consumers now have the strongest set of protections in history. More than three million young people have gained coverage through their parents’ plans. Preventive care is free for tens of millions of Americans. And seniors with the highest drug costs are getting big savings on their prescriptions.

At the same time, we’ve seen the start of a transformation in our health care delivery system. New models of care are proliferating. Already, more than two hundred and fifty health organizations, of all shapes and sizes, have agreed to form Accountable Care Organizations. That means as many as four million Medicare beneficiaries now get their care from providers whose bottom line is keeping them healthy. And these new models are spreading rapidly in states and the private market too.

In response to these changes and other new incentives, health care providers are embracing new data tools that make it easier to improve care and share information between providers and patients. Use of basic electronic health records has doubled since 2008. And more than 80 percent of hospitals have committed to being meaningful users of electronic health records by 2015.

Most importantly of all, these changes are translating into real improvements in people’s lives. For example, hospital readmissions in Medicare have fallen nationally and have dropped 25 percent or more in some communities. Meanwhile, we’ve had three years in a row of historically low growth in health care costs. While we can’t attribute this drop entirely to the law, it’s undoubtedly a positive sign.

The Affordable Care Act is the law of the land. It’s here to stay. And it is working. The wheels of progress in American health care are turning. But we’ve only just begun to see the difference this law can make.

In the coming months and years, we’ll have a huge opportunity to significantly speed up the transformation of health care in a way that will benefit all Americans. But we will need the continued efforts of partners, across the health care system and around the country, to achieve this law’s full potential.

That starts with expanding coverage to tens of millions of Americans who are currently outside the system. As you know, new marketplaces are now being built in every state that will make affordable coverage available to millions of Americans beginning January 1st. In addition, many states will be expanding their Medicaid programs.

For people without insurance, the benefits of coverage are huge. They’re more likely to get preventive care and checkups. They don’t have to weigh the cost of going to the emergency room when their five-year-old wakes up with a fever. There’s no risk of losing it all if they get seriously ill and run up a big hospital bill.

But the truth is that when our friends and neighbors can afford the health care they need, that’s not just good for them. It’s good for all of us. We all benefit when our premiums are no longer inflated with tens of billions of dollars in added costs for uncompensated care. We all benefit when workers can spend more time on the job, and kids can spend more time in school.

And one reason we need influential voices like yours to make these points is that several states are still weighing the decision about whether to expand their Medicaid programs – decisions that will affect whether millions of Americans can get coverage.

These states are being offered an incredible deal. If they expand their Medicaid programs to serve adults making up to around $ 1200 a month and families making up to around $ 2500 a month, then the federal government will pick up 100 percent of the bill for the first three years and at least 90 percent of the bill after that.

Think about that deal. In exchange for picking up a tiny fraction of the tab, states can dramatically expand health coverage for working families, increase productivity, save lives, and reduce their burden of uncompensated care. That’s as good a deal as any state is going to get, and you can help get these facts into the debate.

Merely expanding access to health insurance is not enough, however. Unless people know affordable coverage is now available to them – and unless they know how to get it – they’re going to remain on the outside of our health care system looking in.

That means over the next year we’re also going to have to reach out directly to millions of Americans who, in many cases, have not spent a lot of time in the health insurance market.

Some of these people may believe that affordable health insurance is out of reach for them. They’re so used to exorbitant premiums and insurance companies jerking them around that they’ve understandably come to believe that having coverage will never be an option.

Others are young people. If you have children in their twenties like I do, you know that health insurance is not always their top priority. I don’t always know what that priority is, but it’s not health insurance. Yet we know that young people often take the biggest risk when they go without coverage since they’re less likely to have the resources to cover care out of pocket.

If we’re going to fulfill the full promise of the Affordable Care Act and insure millions more Americans, we’ll need to reach these people. And we’ll need your help to do it.

Part of that is educating people about the new Marketplaces. They need to know that this is a whole new way to shop for health insurance. They’ll be able to submit a single application to find all the plans that fit their budget. Discrimination against pre-existing conditions will be outlawed. And there will be tax credits for working families that could save them money on their coverage right away. People can go to HealthCare.gov right now to learn more and sign up for updates to make sure they don’t miss out on new benefits.

Everyone can play a role in educating Americans about the new coverage options that are coming. If you’re a health care provider, you can start talking about them to your patients. If you’re a state or local official, you can share this information with people who seek out government services. If you’re a policy analyst, you can help identify better ways to locate the uninsured and motivate them to purchase coverage. If you’re a researcher, you can help make sure that once people get coverage, they also get the care they need, especially critical preventive services.

Many of us in this room have been arguing for decades that making health coverage affordable to all Americans is one of the best investments we can make as a nation. Now that we finally have the chance to make that happen, we need to do everything we can to make the most of it.

But the coverage expansion isn’t the only part of the law that is kicking into gear over the next year. In the years before the health care law passed, costs were rising at an unsustainable rate.

We often hear about the rising costs in Medicare and Medicaid, but it’s important to remember that this isn’t a unique characteristic of government health programs. In fact, Medicare and Medicaid costs have been growing more slowly than private insurance premiums. The driver is the growth in the underlying cost of care, which was putting equal pressure on family ledgers, corporate balance sheets, and local, state, and federal budgets.

But even though Medicare is not the problem, we knew it could be part of the solution. History shows that innovations in how we pay for care often begin with Medicare and then spread to the private insurance industry. And a critical part of the Affordable Care Act are the new payment models our department is rolling out to help health organizations change the way they deliver care.

Some of our early results have been very promising. I already mentioned the drop in hospital readmissions. We’ve also seen impressive results in our efforts to reduce health care-associated infections, with central line bloodstream infections down more than 40 percent. And in our Strong Start initiative, some participating hospitals are reporting that they’ve reduced their early elective deliveries to close to zero. That means fewer at-risk newborns and fewer admissions to the ICU, at an average cost savings of nearly $ 5,000 per delivery.

But for all the progress we’re seeing, change is not happening fast enough. Far too many patients still experience a health care system that is fragmented, unreliable, and often prohibitively expensive. Far too many health care providers are still content to sit back and let others blaze the trail towards a 21st century health care system. So my challenge to all of you today – and especially to the provider community – is to speed up the rate of change.

If you are already at the vanguard of transforming care, now is the time to take the next step forward. If you have been considering participating in a new care model, now is the time to take the plunge. If you have been waiting on the sidelines, now is the time to get in the game.

Health services researchers and policy analysts have a role to play. For years, you have helped identify our health care system’s biggest problems and evaluate solutions. But too often those results have come in a 200 page report five years after a study launched. We can’t afford to wait five years to find out what qualities make a successful ACO. We need that information in real time so we can use it to shape policy to have the biggest impact on people’s lives.

I want to be clear: the transformation I’ve talked about today will not happen overnight. When this conference convenes next February, there will still be uninsured Americans we need to cover. There will still be rising costs we need to control. There will still be models of care that need to be evaluated.

But we have a rare opportunity over the next year to make huge strides together in transforming our health care system. If we can take advantage of that opportunity, the payoff for the American people in better care, better health, and lower costs will be enormous.

Thank you.
Healthcare, Technology & Government 2.0


Risks and the Benefits: What Health Policy Can Learn from Clinical Medicine

A few months back, we admitted a patient we’ll call Mr. Jones to the hospital for a severe gastrointestinal bleed.  We had discharged him two weeks earlier after he had come in with a heart attack and made sure he was on aspirin to prevent future cardiac events.  He dutifully took his aspirin and on the day of the readmission, had a massive bleed.  He made it to the hospital barely alive and an endoscopy in the ICU showed an active bleeding gastric ulcer.  For Mr. Jones, the gastrointestinal bleed, likely brought on by the aspirin, was an “unintended consequence” that almost killed him. Yet no one questioned whether we should have given him aspirin in the first place.  I felt terrible about what had happened but found solace in knowing that while for some patients the risks of aspirin are worse than the benefits, for the general population of people like Mr. Jones, the benefits are clearly worth the side-effects.

We do risk-benefit analyses every day in clinical care, knowing that for some patients, the benefits will be outweighed by the harm.  We try to be thoughtful about who might be hurt or not, but most of the time, we just can’t predict.  So, when the benefits appear to outweigh the risks, we move forward and try to learn from cases like Mr. Jones.

While this kind of risk-benefit analysis is common in clinical practice, it’s unfortunately not how we discuss health policy interventions.  No policy intervention is ever without risks, and it is rare that a new policy will have no side-effects at all.  Yet, every time policymakers put in a new initiative, they sell it as a panacea. Critics, upon finding an unintended consequence, then declare the whole thing a failure.

An excellent example of this is health information technology, a topic that I have blogged about in the past.  Proponents only talk about its benefits, allowing critics to highlight every shortcoming and failure.  Thank goodness I don’t have to deal with proponents and critics like that every time I consider prescribing aspirin to my patients.

From this backdrop comes an important new JAMA study by Dr. Karen Joynt (on which I was senior author).  We examined what happens to patients with an acute myocardial infarction in states that have public reporting of outcomes for patients undergoing percutaneous coronary intervention (PCI, better known as angioplasty and stenting).  Three states have instituted mandatory public reporting of outcomes for this procedure.

Proponents of public reporting argue that transparency will motivate poor performers to improve and provide information that consumers can use to choose the best providers. However, it was not without controversy.  The critics voiced concern that public reporting would lead to denial of care for the sickest patients because doing so could make physicians’ mortality statistics look worse.  Whether public reporting leads to better care, unintended consequences, or both is an empirical question – a question our research team wanted to answer.

So what was the punch line?  We found that public reporting was associated with reduced access to PCI for patients who had a heart attack.  Stated simply, in states with public reporting of angioplasty outcomes, heart attack patients were less likely to receive this life-saving procedure.  This was especially true among the sickest patients (the ones who probably benefit the most).  Even more concerning, there was a trend towards higher mortality for heart attack patients in public reporting states, presumably because they were less likely to receive this life saving therapy (this effect was small and not consistently statistically significant).  This was clearly an unintended consequence, and a bad one at that.

Transparency – making outcomes public so patients have access to information – clearly has its upsides as well.  There’s evidence that public reporting of PCI has led to lower procedure complication rates, presumably because providers are being more careful. There’s evidence from cardiac surgery that public reporting pushed some of the worst performing surgeons to stop doing surgery altogether.  While difficult to measure, making the healthcare system more transparent to patients has its own benefits in terms of increased trust.

The lesson to draw from our paper in JAMA is that no policy, no matter how well intentioned, is without side effects.  Our job is to think about how to minimize those side effects.  We could improve risk-adjustment methods so that cardiologists get more credit for performing PCI on the sickest patients.  We could carve out some exceptions from public reporting, as Massachusetts has been trying to do, as a response to this kind of data.  Or, ultimately, we can hope that over time, physicians get used to public reporting and simply do what is right for their patients.

When aspirin was first tested in heart attack patients nearly two decades ago, large randomized, controlled trials were conducted, giving us precise estimates of both the benefits and harm.  We could make thoughtful clinical decisions about whether it was worth it or not and in whom.  Most health policy interventions are not tested rigorously before they are implemented.  That’s why we need robust health policy research after policies go into effect.  We need these studies not to discover whether there are any unintended consequences – there usually are – but rather, to quantify the benefit and the downsides so that we as a society can make thoughtful decisions about whether the policies are worth it or not.  Despite the fact that Mr. Jones had a horrible complication from aspirin, I will continue to prescribe it to my heart attack patients.  Despite the fact that transparency seems to reduce access to PCI for critically ill patients, I will continue to advocate for it in healthcare.  The question we now need to ask is how can we do it in ways that lets us maximize the benefit and minimize the harm.

Ashish Jha, MD, MPH is the C. Boyden Gray Associate Professor of Health Policy and Management at the Harvard School of Public Health. He blogs at An Ounce of Evidence.

The Health Care Blog


Proposed mandatory insurance policy sparks petition

Proposed mandatory insurance policy sparks petition
International students at the University of Northern Iowa were told in April they must enroll in the Student Health Insurance Plan, a plan which works in conjunction with the Student Health Services. A proposed mandatory health insurance policy for …
Read more on Northern Iowan

U. implements Affordable Care Act policies
As a result of the law, a notable increase in prescription coverage came into effect last fall for students enrolled in the University's health care insurance plan, said Jeanne Hebert, director of insurance and purchasing services. Yearly outpatient …
Read more on The Brown Daily Herald


At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.

The HITECH Act, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (ARRA or ‘economic recovery’ act), is proving to be an example of what should be called “Social Policy Malpractice.”

The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records“, May 16, 2009).

It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture.

The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:
 

  • Budget reports – in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance. 

Of course, I’d already cited these reports in past posts but they bear repeating:

      • FDA (known injuries and deaths are likely the “tip of the iceberg” because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they’re a political hot potato - Jeff Shuren MD JD, CDRH), http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html;
      I’d called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts here and here.
       
      The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters. 

      Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  

      This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on “physician learned helplessness” at http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html (commenting on observations in MedScape written by a lawyer), as well as on the “Stckholm Syndrome”  at http://en.wikipedia.org/wiki/Stockholm_syndrome. 

      Per a psychiatrist/informatics specialist Dr. Scott Monteith who has commented on this blog, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the Milgram Experiment (and elsewhere):

      The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View.


      As to the consequences of physician “acceptance” of this technology in 2012 in its present condition, physicians are:

      • Acting, in effect, ‘in loco parentis’ for their patients, not in the latter’s best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the Belmont Report, Nuremberg Code and HHS human subject protection regulations at 45 CFR part 46 themselves;
      • Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;


      National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well, as I pointed out in yesterday’s post “Cracking the Codes: Former ONC Chair Kolodner a “Faith-Based Informatics” Extremist?“:
      … This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS:

      Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology.

      Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”

      In other words, sideline (ignore) health IT-based billing fraud (and safety risks to the live patients subjected to this experimental technology without informed consent) because “we believe” the savings will be greater based on “our faith in the technology.”

       

      Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.

      Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report “Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions” that:

      In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

      This research must be conducted, of course, with full human subjects protections in place.

      – SS

      Health Care Renewal


      2012: A Year of Huge Uncertainty in Health Care Policy

      Health Care Policy and Marketplace Review


      Louisiana School Reconsiders Policy That Can Force Students To Take

      Louisiana School Reconsiders Policy That Can Force Students To Take
      Under the school's policy, which is posted on its website, "The school reserves the right to require any female student to take a pregnancy test to confirm whether or not the suspected student is in fact pregnant." In cases where a test determines that …
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