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Tag: HIT

Healthcare’s Tech Disconnect: Why Aren’t We Building the Products Patients Really Need?

Having been supported by several small business grants from the National Cancer Institute to create online interventions for cancer patients, I have been learning gradually about commercialization models to get our work out to the public. I am dismayed about the major disconnect between eHealth entrepreneurs and eHealth intervention researchers (my personal reference group).

Last year I attended Stanford Medicine X and last week I did a demo of one of our web sites at Health 2.0 in Santa Clara. Both times, I was struck by the assumption in the IT developer and consumer community that giving people realtime feedback about their health will automatically result in major positive changes in behavior, not to mention cost savings for insurers.

The Connected Patient movement seems particularly naïve to me. Psychologists have been using self-monitoring, i.e. recording behaviors such as smoking, eating, and exercise, for at least 30 years to promote behavior change. First we used paper-and-pencil diaries, but researchers like Saul Schiffman quickly adapted the first handheld computers to prompt people to record their behaviors in realtime, greatly increasing the accuracy and power of self-monitoring.

As technology has advanced, so have our means of self-monitoring. Overall, however, the technology matters far less than the procedure itself. For most people, tracking their smoking, calories, mood, or steps does change unhealthy behaviors somewhat, for a limited period of time. A small group of highly educated, motivated people is more successful in using self-monitoring to make larger, more lasting changes.

I was reminded of this last year in a seminar on tracking at Stanford Medicine X, when a concierge physician from San Francisco and several of his patients talked about being empowered to change their health by using feedback from various types of sensors. One had paid out of pocket for a continuous blood glucose monitor since his insurance would not cover the costs to use it for his Type II diabetes.

Another doggedly demanded access to the data from his cardiac defibrillator. They believed their experiences heralded a sea change in health care in the United States. I am all for empowering patients with knowledge, tracking tools, and social support.

However, if knowledge and feedback was all it took to change unhealthy behaviors, psychologists would be superfluous in the world.

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A Little Advice for the Next National Coordinator

Over the next few months, Jacob Reider will serve as the interim National Coordinator for Healthcare IT while the search continues for Farzad Mostashari’s permanent replacement.

What advice would I give to the next national coordinator?

David Blumenthal led ONC during a period of remarkable regulatory change and expanding budgets. He was the right person for the “regulatory era.”

Farzad Mostashari led ONC during a period of implementation when resources peaked, grants were spent, and the industry ran marathons every day to keep up with the pace of change. He was the right person for the “implementation era”

The next coordinator will preside over the “consolidate our gains” era. Grants largely run out in January 2014. Budgets are likely to shrink because of sequestration and the impact of fiscal pressures (when the Federal government starts operating again). Many regulatory deadlines converge in the next coordinator’s term.

The right person for this next phase must listen to stakeholder challenges, adjust timelines, polish existing regulations, ensure the combined burden of regulations from many agencies in HHS do not break the camel’s back, and keep Congress informed every step of the way. I did not include parting the Red Sea, so maybe there is a mere human who could do this.

What tools does the coordinator have in an era of shrinking budgets?

At present, Meaningful Use Stage 2, ICD-10, the Affordable Care Act, HIPAA Omnibus Rule, and numerous CMS imperatives have overlapping timelines, making it nearly impossible for provider organizations to maintain operations while complying with all the new requirements.

Can resources be expanded?

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Why Badly Designed iPad Apps Put Patients at Risk: EMS and ePCR

Everyone who knows my writing can attest that I neither pull punches nor play politics. It may distress people, and hopefully it won’t harbinger my demise.  But as CEO of a young firm bringing overdue innovations to the Fire and Emergency Medical Services industry, there are only four groups to whom I am duty-bound: our partner-clients, their patients, our team members, and our investors (in no specific order).  To remain mum on topics that could affect the physical or financial health and wellbeing of any of these parties would be a disservice.

When I was in the magazine business, I often used the phrase “Respect the medium.”  The meaning was simple: when every industry player surfing the waves of innovation is trying something new, how many are asking whether the form is appropriate to the intended function?  What changes need to be made to magazine’s font so its text can be read clearly on a small, backlit screen?  What interactivity can be embedded into a digitally delivered? How will the user’s experience change when network access is down?  (In February 2012, I wrote about these topics for Electronic Design Magazine.)

Failure to ask these questions is often the downfall of the delivery method: either the medium changes or its use declines; rarely do customers acclimate.  In the publishing world, if your readers ignore you, you go away—no lasting harm or foul.  Not so in healthcare or public safety. Especially during emergencies, if a product fails to work as intended—or to work at all—it can mean lost productivity, mountainous legal fees, brain death, or loss of life, limb and property.

Healthcare IT offers outsized benefits to Emergency Response teams, which depend on speed, ease of training and use, data accuracy, and interoperability.  But the stakes of failure or disruption are so high that one can say there are few areas of development with a more desperate need for criticism.

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Washington In Crisis: ONC Announces That It Will Not Tweet Or Respond to Tweets During Shutdown

The U.S. government shutdown continues to claim victims.

The latest is HealthIT.gov, the website designed to help doctors and hospitals make the transition to electronic and make better use of health information technology – a key component of Obamacare’s drive to transform healthcare.

The Health Information Technology Office of the National Coordinator posted a brief announcement on the site informing visitors to HealthIT.gov that “information … may not be up to date, transactions submitted via the website may not be processed and the agency may not be able to respond to inquiries until appropriations have been enacted.”

Officials also sent a tweet saying that the ONC regrets to inform us that while the shutdown continues it will “not tweet or respond to tweets.”

This struck THCBist as slightly odd.

After all, if you’re looking for an inexpensive way to communicate with the public in a pinch, Twitter seems like the perfect choice.  We get that government websites are ridiculously expensive things to run. Blogs are considerably cheaper.  Operating a Twitter account — on the other hand — is almost free.  Our brains were flooded with scenarios.  How much could the ONC possibly be spending on Twitter? And for that matter, didn’t the Department of Defense originally invent the Internet to allow for  emergency communication during times of national crisis? Doesn’t a fiscal insurrection by cranky Republicans qualify?

Fallout for the National Health IT Program

While federal officials have issued repeated assurances that the shutdown will not impact the Obamacare rollout, it does look as though there will be a fairly serious impact on the administration’s health IT program.  If HHS sticks to script, only 4 of 184 ONC employees will remain on duty during the shutdown. That makes it sound like activities are going to have to be scaled back just a bit.

If you’re counting on getting an incentive payment from the government for participation in the electronic medical records program, you may be in trouble — at least until the stalemate is settled.  Although ONC has not yet made an official statement,  presumably because the aforementioned Twitter channel has been disabled, leaving the agency unable to speak to or otherwise communicate with the public, going by the available information in the thirteen-page contingency plan drafted by strategists at HHS, it is unclear where the money will come from.

This could be bad news for electronic medical records vendors counting on the incentive program to drive sales as the Obamacare rollout gets officially underway.

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Five Must-See New Technologies for Hospitals at Health 2.0

More than ever, hospitals are squeezed by demands to reduce costs, operate more efficiently, improve patient safety and outcomes, reduce readmissions, and earn high patient satisfaction ratings. We’ve entered an era where accountable care and pay for performance increasingly dictate hospital revenues.

While technology alone can’t enable hospitals to meet their challenges, there’s a burst of innovation around health tech tools that offer hospitals new pathways to harnessing data, managing performance, and providing better care all around.

What better opportunity for hospital CIOs and CTOs to get a close look at emerging possibilities than the upcoming Health 2.0 2013 Fall Conference?

Here’s a sampling of five budding technologies with game-changing potential for hospitals.

Health Recovery Solutions’ has developed a care management system that scores discharged hospital patients on their re-admission risk daily and intervenes when necessary. The tools are built around a software platform on tablets that patients take home, enabling interaction with trained health coaches and nurses who can intervene when needed.

Catch a demo as part of Health 2.0’s Improving the Inpatient Experience: Tools for Hospitals, a breakout session demonstrating new and dynamic ways to break the structural cycles underlying readmissions.

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A Troubling Strategy at Health IT Week

Health IT Week demonstrated a double barrel strategy to segregate patient information from provider information. Providers already have the power to set prices and health IT plays the central role.

By rebranding HIPAA as “Meaningful Consent” and making patients second-class citizens in Meaningful Use Stage 2 interoperability, providers and regulators are working together to keep it that way.

Essential consumer protections such as price transparency or independent decision support are scarce in the US healthcare system. The journalists are shouting from the rooftops.

There’s  $1 Trillion (yes, $3,000 per person per year) of unwarranted and overpriced health services steering the Federal health IT bus with an information asymmetry strategy. Those of us that want to see universal coverage succeed need the information transparency tools to drive for changes.

Here’s how it works: The department of Health and Human Services (HHS) controls the health IT incentives and regulations. HIPAA applies to most licensed health services providers. Laboratories and devices are regulated by Medicare and the FDA.

Unlicensed services offered directly to patients, such as personal health records, web info sites and apps are regulated by the FTC. Separate regulatory domains facilitate the segregation of information and contribute to the lack of transparency by making patient-directed services use delayed and degraded information. This keeps independent advice from FTC-regulated service providers from illuminating the specific abuses.

The segregation of patient information from “provider” information is the current federal regulatory strategy. It’s even more so in the states. By making patients into second-class citizens, the providers can avoid open scrutiny, transparent pricing, and independent decision support.

Federal regulators then create a parallel system where information is delayed, diluted, and depreciated by lack of “authenticity”. This is promoted as “patient engagement”. For regulators, it’s a win-win solution: the providers support the regulation that enables their price fixing and many patient advocates get to swoon over patient engagement efforts.

The proof of this strategy became clear on the first day of Health IT Week – the Consumer Health IT Summit.

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Can Entrepreneurs “Cure” Health Care With Technology?

Today marks the beginning of the 8th annual Healthcare IT Week. Healthcare IT Week was started and continues on as a collaborative forum for public and private healthcare constituents to discuss the value of health information technology (health IT) for the U.S. healthcare system.

It is amazing to see how far health IT has come over the last 10-15 years.  It has its own week!  If, a decade ago, you told people that health IT would be a core focus of investors, entrepreneurs and everyone else in healthcare, the energy produced from the eye rolling alone could power the lights on the Las Vegas Strip for a month.  The basic sentiment back then was this: Why would anyone invest in, think about, care about health IT when the consumer Internet was rocking and companies selling online dog food could get started on Monday and sold on Friday for a bull mastiff’s weight in gold?

Today it is quite clear that healthcare IT is a hugely significant part of any success we are having and will continue to have in transforming our healthcare system from one where 30% of cost and care is wasted or the result of error to one where value reigns supreme.  We do not believe anyone rational would now argue that healthcare IT is non-essential to improving the quality, productivity, efficiency, cost and outcomes we produce in our healthcare system, although the path is not always smooth.

And it’s about time. Technology has been used to optimize and redefine virtually every key industry except healthcare. Manufacturing has gone from human assembly lines to robotics; banking has gone from tellers to home banking; travel has gone from agents with brochures to Travelocity; and yet in many ways, the fundamental practice of medicine hasn’t changed in decades.

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Regulating Health IT: When, Who, and How?

Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.

Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.

Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.

But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.

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What Keeps Me Up At Night – 2013 Edition

Now that Labor Day has come and gone,  I’ve thought about the months ahead and the major challenges I’ll face.

1.  Mergers and Acquisitions

Healthcare in the US is not a system of care, it’s a disconnected collection of hospitals, clinics, pharmacies, labs, and imaging centers.  As the Affordable Care Act rolls out, many accountable care organizations are realizing that the only way to survive is to create “systemness” through mergers, acquisitions, and affiliations. The workflow to support systemness may require different IT approaches than we’ve used in the past. We’ve been successful  to date by leaving existing applications in place and building bidirectional clinical sharing interfaces via  “magic button” viewing and state HIE summary exchange. Interfacing is great for many purposes.  Integration is better for others, such as enterprise appointment scheduling and care management. Requirements for systemness have not yet been defined, but there could be significant future work ahead to replace existing systems with a single integrated application.

2.  Regulatory uncertainty

Will ICD10 proceed on the October 1, 2014 timeline?  All indications in Washington are that deadlines will not be changed. Yet, I’m concerned that payers, providers and government will not be ready to support the workflow changes required for successful ICD10 implementation.    Will all aspects of the new HIPAA Omnibus rule be enforced including the “self pay” provision which restricts information flow to payers?  Hospitals nationwide are not sure how to comply with the new requirements.   Will Meaningful Use Stage 2 proceed on the current aggressive timeline?  Products to support MU2 are still being certified yet hospitals are expected to begin attestation reporting periods as early as October 1.   With Farzad Mostashari’s departure from ONC, the new national coordinator will have to address these challenging implementation questions against a backdrop of a Congress which wants to see the national HIT program move faster.

3.  Meaningful Use Stage 2 challenges

Although attestation criteria are very clear (and achievable), certification is quite complex, especially for a small self development shop like mine.   One of my colleagues at a healthcare institution in another state noted that 50 developers and 4 full analysts are hard at work at certification for their self built systems.   I have 25 developers and a part time analyst available for the task.   I’ve read every script and there are numerous areas in certification which go beyond the functionality needed for attestation.    Many EHR vendors have described their certification burden to me. I am hopeful that ONC re-examines the certification process and does two things – removes those sections that add unnecessary complexity and makes certification clinically relevant by using scenarios that demonstrate a real world workflow supporting the functionality needed for attestation.

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Why Doctors Should Stay Out of the Business of Building EHRs

The original Hipoocratic Oath states:

I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.

One modern version reads:

I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.

The idea here is that a doctor needs to recognize when another practitioner has a skill that they do not, and that they must refrain from “practice” when another person has demonstrable expertise in that area of practice.

It is now 2013. It is time for doctors to stop “writing their own EHR” from scratch. They need to bow out of this in favor of people who have developed expertise in the area.

I just found out about another doctor who has decided to write his own EHR, because he has not been able to find one that supports his new direct pay business model adequately. In the distant past I encountered a doctor who believed that his “Microsoft Word Templates” qualified as an EHR system. This is a letter to any doctor who feels like they are comfortable starting from-scratch software development for an EHR in 2013 or later.

You might believe yourself to be an EHR expert.

Are you sure about that? Are you sure that you are not just an EHR expert user?

This difference is not unlike your relationship with your favorite thoracic surgeon. Or for that matter, your relationship with the person who built your car. The fact that you are capable of expertly evaluating and using EHR products does not mean you are qualified to build one. Just like the fact that you are qualified to treat a patient who has recently had heart surgery or to discern when a patient might need heart surgery does not make you qualified to perform that heart surgery. Similarly, the fact that you can drive, or even repair your automobile, does not provide you with the expertise you need to build a car from scratch.

The ethical situation that you are putting yourself in by developing your own EHR is fairly tenuous. Performing heart surgery without being a heart surgeon, building and driving your own car without being an automotive engineer and a doctor coding their own EHR system from scratch all have the same fundamental problem: You might be smart enough to pull it off, but if you don’t you can really mess up another person’s life. Make no mistake, you can kill someone with a shoddy EHR just as easily as by performing medical procedures that you are not qualified for or by driving a car that is not road-safe.

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