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Medical Devices and Patient Safety: A Promising Path Forward

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By Daniel, Gardina & Strait

flying cadeuciiIn an era of sophisticated information technology and rapid communication, the medical device community lags far behind other fields in its ability to alert patients about safety concerns.

For example, auto manufacturers and government regulators are able to quickly identify potential safety concerns by linking reports of crashes, malfunctions and defects with individual vehicle identification numbers (VINs).

They can then communicate recalls to affected customers by using their VIN. Manufacturers will issue notifications via mail or e-mail, or offer customers the ability to search the manufacturer’s website using their VIN.

In health care, drugs are tracked using a system established in the 1970s called National Drug Codes (NDCs). The 10-digit NDCs are assigned to all manufactured medications. The code tracks the vendor, product, and package code, which can then be captured in electronic health records and the FDA’s national database.

Unfortunately, we do not yet have a similar national system that can identify and communicate potential concerns for the tens of millions of patients with implantable devices such as pacemakers, glucose meters, artificial joints, and defibrillators.

Patients are bombarded by news stories about device recalls, but unless they have access to information about the exact make and model of their device, they have no way of knowing if they should be concerned. Since most medical device procedures take place in a hospital, a patient’s health care providers may also lack this critical, sometimes life-saving information.

The patient is then burdened with the task of tracking down their specialist or surgeon, in hopes that they documented the specific device information.

Clearly, the current health care information infrastructure does not yet support a robust surveillance system.

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Using Technology to Better Inform Consumers about Privacy Decisions

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By Cameron F. Kerry

Screen Shot 2014-04-30 at 11.21.56 AM

At the first White House public workshop on Big Data, Latanya Sweeney, a leading privacy researcher at Carnegie Mellon and Harvard who is now the chief technologist for the Federal Trade Commission, was quoted as asking about privacy and big data, “computer science got us into this mess; can computer science get us out of it?”

There is a lot computer science and other technology can do to help consumers in this area. Some examples:

•    The same predictive analytics and machine learning used to understand and manage preferences for products or content and improve user experience can be applied to privacy preferences. This would take some of the burden off individuals to manage their privacy preferences actively and enable providers to adjust disclosures and consent for differing contexts that raise different privacy sensitivities.

Computer science has done a lot to improve user interfaces and user experience by making them context-sensitive, and the same can be done to improve users’ privacy experience.

•    Tagging and tracking privacy metadata would strengthen accountability by making it easier to ensure that use, retention, and sharing of data is consistent with expectations when the data was first provided.

•    Developing features and platforms that enable consumers to see what data is collected about them, employ visualizations to increase interpretability of data, and make data about consumers more available to them in ways that will allow consumers to get more of the benefit of data that they themselves generate would provide much more dynamic and meaningful transparency than static privacy policies that few consumers read and only experts can interpret usefully.

In a recent speech to MIT’s industrial partners, I presented examples of research on privacy-protecting technologies.

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Moore’s Law in Healthcare – Three Predictions

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By Nick Dawson

apple storeJe n’ai fait celle-ci plus longue que parce que je n’ai pas eu le loisir de la faire plus courte. —Blaise Pascal

Translation: I have made this longer than usual because I have not had time to make it shorter.

As Appley as it gets.

A while ago I was challenged to write about what an Apple-like approach to healthcare might look like.

That challenge has been weighing on me.

For starters, we’re all over Appled aren’t we? Maligned anecdotes about Steve Jobs and the iPhone make their way into almost every presentation remotely related to innovation or technology. Triteness aside, I’ve been stalled because Apple is really a philosophy, not a series of steps or lessons learned. (Although, they are nonetheless methodical.)

Instead, what I’ve been kicking around in the ole noggin are three notional predictions, which I’ll assert are inevitabilities which will fundamentally disrupt healthcare delivery as we know it today.

What follows is about as Appley as I’m likely to get. Despite big-bang product launches, Apple actually plays the long game. They introduce small features into products to affect user behavior years before a flagship product takes advantage of those reprogramed behaviors.

That’s how they disrupt.

I believe there are three meaningful, unstoppable trends, in our current world which will significantly alter healthcare. The steps taken towards these inevitabilities, along the way, are what will define the innovators and leaders. They are the ones who see this future and know how to drive towards it.

The three trends are:

  • Tools and culture which favor individual empowerment
  • The commoditization and automation of diagnosis
  • Accelerated globalization of treatment options

But wait, there’s Moore.

Don’t worry, I’m not going to leave you hanging. I’ll attempt to rationalize each of these points and explain why, particularly when considered as a bundle, they are a powerful force for disruption. And to prime that pump, we have to talk about Gordon Moore.

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Crowdsourcing the Kaiser Permanente Center For Total Health

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By THCBist

Our friends at Kaiser Permanente asked us reach out THCB readers for help with a cool crowdsourcing project. The Kaiser innovation team is working on developing new content for The Kaiser Permanente Center For Total Health , KP’s shiny new 16,000 square foot exhibition and meeting space in downtown Washington D.C.

If you’re close enough to make the trip, we highly recommend that you stop by and take an hour or so to poke around a bit before submitting your suggestions.  Failing that, you can take the online interactive tour here.

If you’re a doctor, a med student, a designer, an entrepreneur, a patient – or if you just have a good idea –  we’d like to hear from you.  KP’s innovation team asked us to ask you four questions. You can answer one or you can answer them all.

1.  What is Total Health? In other words, what is health? What’s important to you?

2. What should total health look like when implemented? What innovations can be used to drive change in the healthcare system? What will healthcare look like in the future?

3.How should total health be supported? What can be done to make healthcare better? Smarter?  Both within the healthcare system? And in our own lives?

4. If you were designing an interactive wall to demonstrate total health to visitors what would you focus on. In other words, if you were designing an exhibition what would it look like? What would your message be? What would help educate the public? How would you get that message across? Yes, you can send us an picture.

Answers can be left in the comment thread below. If you prefer to submit a video response via YouTube send the link to editor@thehealthcareblog.com. or paste in the comments below.  Blog posts should be submitted to THCB editors at editor@thehealthcareblog.com

For the interactive design question, we asked THCB’s editors what they’d like to see. Here’s what we came up with on the back of our paper napkin:

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IDESG Is a Glimpse of Our Digital Future

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By Adrian Gropper, MD

I’ve recently returned from the 7th ID Ecosystem Steering Group Plenary in Atlanta. This is an international public-private project focused on the anything-but-trivial issue of issuing people authoritative cyber-credentials: digital passports you can use to access government services, healthcare, banks and everything else online.

Cyber ID is more than a single-sign-on convenience, or a money-saver when businesses can stop asking you for the names of your pets, it’s rapidly becoming a critical foundation for cyber-security because it impacts the resiliency of our critical infrastructure.

Healthcare, it turns out, is becoming a design center for IDESG because healthcare represents the most diverse collection of human interactions of any large market sector. If we can solve cyber-identity for healthcare, we will have solved most of the other application domains.

The cyber-identity landscape includes:

  • proving who you are without showing a physical driver’s license
  • opening a new account without having to release private information
  • eliminating the risk of identity theft
  • civil or criminal accountability for your actions based on a digital ID
  • reducing your privacy risks through anonymous or pseudonymous ID
  • enabling delegation to family members or professional colleagues without impersonation
  • reducing hidden surveillance by state or private institutions
  • when appropriate, shifting control of our digital tools to us and away from corporations

The IDESG process is deliberate and comprehensive. It impacts many hot issues in health care including patient matching, information sharing for accountable care and population health, health information exchanges, prescription drug monitoring programs, accounting for disclosures, patient engagement and meaningful use, the physician’s ability to communicate and refer without institutional censorship, the patient’s ability to control information from our increasingly connected devices and implants, and more.

Hospitals and health industry incumbents that seek to solve the hot issues raised by health reform are not eager to wait for a deliberate and comprehensive process. For them, privacy and cyber-security is a nice-to-have. Who will pay for this digital enlightenment?

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To Buy Or Not to Buy

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By ROBERT LASZEWSKI

Now that consumers can generally make an efficient health insurance purchase at HealthCare.gov and most of the state-run exchanges, we can finally get to the real question.

Are the healthy uninsured going to buy it?

The big health insurance changes Obamacare made to the individual and small group market were arguably done in order to get everyone, sick and healthy, covered in a more equitable system.

To be clear, no one I know of wants to go back to the prior health insurance market that excluded people from being covered because of pre-existing conditions.

But what if most of the uninsured literally don’t buy Obamacare?

Then people will question whether or not all of this change was worth it: Why did those who were in the old individual and small group market have to accept all of the expensive changes, narrower networks, higher deductibles, and fewer choices if the uninsured largely don’t want it?

Are we moving away from a system where only the healthy could buy health insurance to a system where only the sick want to buy it?

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In Search of a Really Usable PHR

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By Leslie Kernisan, MD

When it comes to the health care of a frail older person, families really need a good personal health record (PHR) system. So I am once again preparing to take a look at what’s available, in hopes of finding something that I can more confidently recommend to the families I work with. (To see what medical info I urge families to track, see this Geriatrics for Caregivers post.)

I have — yet again — met a family with reams of paper health records. On one hand, they’ve done very well: at our first visit they were able to show me labs, MRI results, and even some specialty consultations from last summer. They even had a hospital discharge summary, although unfortunately not the one from the most recent hospitalization.

And they’d taken steps to digitally organize, having scanned several key items, as well as created an online space providing shared access to their parent’s information.

So this is better than the situation I often encounter, which is that an elderly person has seen multiple outpatient doctors, has been hospitalized in a few different facilities, and no one has a copy of anything handy. (See why new elderly patients are a killer in primary care? If there is no data you fly blind, if there IS data it can take hours to review it.)

Still, there are clearly many ways a little well-designed technology could improve things for this family – and for the doctors trying to help them.

Here are the problems we have right now:

  • Hard to search the whole pile, whether on paper or via the family’s online repository of  PDFs. These were not OCRed and searchable until I manually converted them with my own PDF editor,  after which I had to upload them to the patient’s chart in my EMR. Now each file is text searchable (for me), but the pile still is not.
  • Cannot trend the labs. Figuring out what has happened to this patient’s key lab values over the past year has been very labor-intensive. This remains a problem once the lab data is uploaded to my EMR, because it’s still in PDFs which have to be looked at one at a time. Being the nerdy doc that I am, I’ve spent a fair bit of time creating a note that summarizes the key lab data over time. Ugh. Better than nothing but a far cry from being able to graph and trend the patient’s labs as needed.
  • Takes ongoing time and effort to get records from the hospitals and other involved doctors. Kudos to this family for being diligent and persistent in asking for copies of everything they can. But wow, it’s a lot of effort for them, and I can tell you that in my practice so far, I’ve generally had to expend a fair amount of energy repeatedly asking for information from other providers. (And then I’ve had to try to organize all this info which comes in as scanned images via fax. Oy!)

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Darwinian Health IT: Only Well-Designed EHRs Will Survive

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By Edmund Billings, MD

Remember the Ford Pinto and the AMC Pacer, aka the Pregnant Pinto?

Both serve as reminders of an in era in which the American auto industry lost its way and assumed drivers would buy whatever they put on the lot. Foreign competition, primarily from Japan, filled the void created by American apathy for quality and design, and the industry has never been the same.

Admittedly, the comparison of cars and EHRs is less than apt, but health IT also assumes healthcare will buy what we’re selling because the feds are paying them to. And, like the Pinto, what we’re selling inspires something less than awe. In short, we are failing our clinical users.

Why? Because we’re cramming for the exam, not trying to actually learn anything.

Myopic efforts to meet certification and compliance requirements have added functionality and effort tangential to the care of the patient. Clinicians feel like they are working for the system instead of it working for them. The best EHRs are focused on helping physicians take care of patients, with Meaningful Use and ICD-10 derivative of patient care and documentation.

I recently had dinner with a medical school colleague who gave me insight into what it’s like to practice in the new healthcare era. A urologist in a very busy Massachusetts private practice, he is privileged to use what most consider “the best EHR.”

Arriving from his office for a 7 PM dinner, he looked exhausted, explaining that he changed EHRs last year and it’s killing him. His day starts at 7 AM and he’s in surgery till noon. Often double or triple booked, he sees 24 patients in the afternoon, scribbling notes on paper throughout as he has no time for the EHR. After dinner he spends 1.5 to 2 hours going over patient charts, dictating and entering charges. What used to take 1 hour now requires much more with the need to enter Meaningful Use data and ICD coding into the EHR.  He says he is “on a treadmill,” that it should be called “Meaningless Use,” and he can’t imagine what it will be like “when ICD-10 hits.”

My friend’s experience is representative, not anecdotal. A recent survey by the American College of Physicians and American EHR Partners provides insight into perceptions of Meaningful Use among clinicians.

According to the survey, between 2010 and 2012, general user satisfaction fell 12 percent and very dissatisfied users increased by 10 percent.

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Why Doctors Should Stay Out of the Business of Building EHRs

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By Fred Trotter

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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