Tag Archives: interoperability

One for the patients, and interoperability.

There’s an announcement that went out a week or so ago from the USA’s Center for Medicare and Medicaid Services. Not much has been written about it. I thought the wording of the statement was interesting enough to spend a few minutes talking about it here.

Essentially, CMS has a regulatory requirement in place that states that providers have to maintain patient health records electronically. They’re using a phased approach toward getting everyone there, and that requirement hasn’t been met by many, mostly because of difficulty in implementing systems to handle this. As a result, they pushed back the date for provider compliance with this rule to January 1, 2018. That’s the bad news.

The good news? Well, patient health records for those on Medicaid (receiving federal or state healthcare assistance) and Medicare (federal healthcare program for U.S. residents 65 and older) will all be electronic by 2018. Also, there is a significant push by CMS to make the systems housing patient information available and accessible to patients. As in, no more wondering what is in your folder, but actually knowing what’s there.

According to the fact sheet distributed by CMS (click HERE for the full text):

”We want actionable electronic health information available when and where it matters most and for health care providers and consumers to be able to readily, safely, and securely exchange information.”

There’s incentive in this too. Eligible physicians, clinics, and hospitals who move to electronic health records receive incentive payments from the government for doing so ahead of schedule. They get their payments cut if they fail to comply by the CMS deadline.

But there were additional items that really struck me in this announcement, and I’m just going to quote them here one at a time.

”For example, the regulations will:
Shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.”

CMS is focusing on using technology to improve patient outcomes, but not in a “set it and forget it” kind of way. They want health records to be useful in a patient’s care plan.

”Address health information blocking and interoperability between providers and with patients. Commenters recommended we emphasize measures that focus on interoperability instead of those that focus on data entry. We modified the measures so that more than 60 percent of measures rely upon exchange of health information, compared to 33 percent previously.”

Anyone who’s been to one doctor for one test, then another doctor who has wanted to perform the same test can tell you that being able to exchange data between providers (in a safe, secure manner, of course) will save a lot of time and money for providers, for patients, for insurance companies. Interoperability is also huge in a hospital setting, or when a patient may not be able to speak for themselves.

”We are Transitioning to a New and More Responsive Regulatory Framework”

Part of that is due to passage of the Medicare Access and CHIP Reauthorization Act of 2015, and part of that is due to the fact that, well, this is the 21st century, and we all need to use technology where it can help us. It’s a no-brainer, right?

Here’s something else to remember: If the federal government is moving toward a more patient outcome based, interoperable, responsive framework, it’s much more likely that individual providers of healthcare will do so too. Seeing how this all works out over the next five years or so will tell doctors, hospitals, and health systems what works and what doesn’t about operating with health IT as “a tool for care improvement, not an end in itself”. My hope is that they will improve upon that idea. They also have incentive in keeping us all alive longer.

So here we are… a little blip on the radar screen of our medical lives. But a significant blip, if the goals associated with these regulations actually come to pass. I’d be okay with that, and the sooner the better.

Repetition is not progress.

If you’ve been following updates from me on Facebook recently, you may know that I’m due for arthroscopic surgery on my left knee in about a week. I haven’t talked about it here because, really, who wants to read about me while I whine about how I’ve been in pain for six weeks?

But I do have a point in talking about it now, so please bear with me.

I had to visit an orthopedic surgeon for the first time once I realized the pain wasn’t going away. This orthopedist, the one who repaired The Great Spousal Unit’s ACL 18 years ago, and fixed her broken ankle five years ago, is also performing my surgery. Seeing him means filling out the requisite paperwork, and at their insistence, registering for their patient portal (it’s a fairly large practice). Aside from the paperwork, and creating a new user name and password that I’ll never remember, I lost about 15 minutes that I’ll never get back. But that’s not all.

After my first visit, I was sent to get an MRI on my swollen, painful knee. I haven’t had an MRI in decades, so this meant going to a new place, filling out more paperwork, and losing another 15 minutes. The radiology practice also insisted that I registered for their patient portal, which I declined this time (“Don’t you want your MRI images mailed to you?” / “No, I’m happy with the CD you gave me, thank you”). Two sets of medical history, drugs that I’m taking, and pump settings. But that’s not all.

My surgery will be performed at a surgical center near my orthopedist’s office. The orthopedic surgeon is part owner in the surgery center. Guess what? The surgery center needed me to submit medical history, a list of medications I’m taking, and my pump settings. And the only way to submit all this is through their patient portal. This fifteen minutes stuff is getting repetitive. Fifteen minutes is time to wait for your BG to come up when you’re low, not to document the same information for the third time in a week and a half.

When People With Diabetes think about interoperability, we often think about getting our CGM readings to display on our insulin pumps, or sharing our CGM data with our spouses while we’re at work. And that’s true… all of that, in my opinion, qualifies as important steps in interoperability.

But I also think of interoperability as having one source of data, in one place, for all to access. For instance: I have my medical information, my device data, my list of medications in one secure place, and I get to decide when I want to share it with a medical team. I give them access to it at my discretion, for the amount of time I decide.

So if I need to see an orthopedic surgeon, and they want to see all of this, I can choose to allow them access to my information, and they can get it with a simple click from their desktops. In an emergency, we’ll have to work out a way so someone can access my information instantly from the hospital.

Certainly, my orthopedist can say to me, “If you don’t allow us access to your medical data, we won’t treat you”. But I’ll know that 1) My medical information is in one place, always; 2) Access to my information could be gained by others at my discretion; 3) My information could be kept up to date and accurate by me, on an ongoing basis (who knows if I made a mistake on that first set of information I submitted, or the second, or the third?); 4) I could revoke access to the data when it’s no longer needed; and 5) The data is available, staff isn’t necessary to hand it out, file it, or access it when my appointment comes up.

I could add to the list all day.

Nearly everyone is on board these days with the idea of less burden on the patient, and what I’m talking about here, in theory, solves some of that. What I think healthcare professionals and insurance companies have forgotten about is the importance of less burden on healthcare professionals themselves, and how less burden on collecting the same data over and over (and not making them read handwritten forms) will gain them extra time to care for patients.

I’m going to keep talking about it, because it needs to be talked about. A central place for someone’s medical information may be just as impactful as interoperability between diabetes devices. I mean, seriously, after my knee gets worked on, they might have to work on my hands because they’re tired from writing and typing. This can and should happen. I hope someone is working on it.

FDA Workshop– I came, I saw, I listened.


I mentioned last week that I would be attending the public workshop at the U.S. Food and Drug Administration, titled Regulatory Science Considerations for Software Used in Diabetes Management.

It was a pretty full day.

Remember, this was a day off from work. You know, that thing I do to make money so I can actually attend these things in person. I woke up earlier than I do when I actually go to work, and instead of leaving the house between 7:00 and 8:00, driving a mile and then getting on a train, I left at 6:00 and drove to FDA headquarters in Silver Spring, Maryland, over an hour away through almost rush hour traffic.

The proceedings started at 8 a.m., and the day started with presentations related to something that I’ve really taken notice of this year: Interoperability.

When I go to meetings and workshops where a lot of presentations are made, I try to go over each person’s message and convey that to you here. This time, I’m not going to do that. Instead, I will refer you to the webcast replay that’s available over at the FDA’s website, where you can get video, audio, and presentation slides. I will, however, share a little of what I experienced on that day.

I always learn a lot when interoperability is discussed. It’s such an interesting subject to me, and it’s an idea that’s long overdue in the diabetes world. I didn’t expect to get much out of the bolus calculator presentations, but I was wrong about that. The talks were very good, and the panel discussion at the end was great to see.

The presentations were all informative and interesting. Particularly, those from Howard Look of Tidepool, who made an excellent presentation, making the case for interoperability based on the simple fact that we need to reduce the burden of diabetes on the patient, and interoperability would most definitely be a step in the right direction. Dr. Joe Cafazzo talked about the research his team is doing in Toronto, working to understand and map out a strategy for a standard of device data interoperability. As someone in the Q & A session mentioned (a corporate representative in the room), think about when you purchase a lamp and it has the UL symbol, or think about how HTML is the standard code throughout the internet. If we can arrive at a standard for diabetes devices, it might make it easier for a company to deliver trusted product to consumers (us), and then market it by saying it meets the standard.

Adam Brown of diaTribe was fantastic speaking about insulin bolus calculators, how they work, and what the impacts of bolus calculators are to people living with diabetes, backing everything up with lots and lots of supporting data (the FDA really likes that). Dr. Howard Wolpert from Joslin Diabetes Center and Jane Seley of New York Presbyterian Hospital gave fact-based talks that confirmed the anecdotal stories they shared about dealing with diabetes patients on the front lines over the course of many years of service.

The panel discussion surrounding bolus calculators was interesting. Most of the discussion had to do with the many bolus calculator apps that are out on the market now. While a calculator within my insulin pump must be approved by the FDA, apps that perform the same function do not right now. The moderator of the panel was convinced that these bolus calculators should be regulated. Adam Brown and Howard Wolpert made a convincing case (in my eyes, anyway) that, in Adam’s words, “a patient using a bad bolus calculator is still better off than a patient just winging it”.

At the end, Dr. Courtney Lias (look her up) shared a few things with us. She appreciated everyone’s viewpoints, and indicated that the FDA intends to continue the discussion. Not sure how yet, but they are willing to commit to having more discussions in the future on these subjects. What is not on the table: Restricting bolus calculators. The important thing, she said, is that the FDA get the right touch between innovation, patient safety, and the idea of benefit vs. risk for people living with diabetes. She reminded us that the patient is key… safe, effective tools to manage diabetes is everyone’s goal… and one person’s diabetes is not like another’s, so not every solution will meet the needs of every PWD.

In addition to all this, I got to sit down at lunch with a person working on the Nightscout project, and with another industry representative. It was great getting a chance to share my story with them firsthand (though I’m not using Nightscout—or a CGM right now).

And during the public comment portion of the proceedings, I was allowed to speak…

Photo of my best side courtesy of Bennet Dunlap

Photo of my best side courtesy of Bennet Dunlap

I’m usually a good public speaker. I enjoy getting up in front of people and talking. This, however was not my best performance, though I think I got my message across. It was basically the same thing I published here earlier. You’ll probably be better off if you go to that and read it to yourself, rather than listening to my ramblings.

Anyway, there were a couple of people left to speak after I was finished, and while I sat there listening to them, something strange happened. I was almost overcome with a wave of emotion. I started to ask myself “What did I just do?” and “Four years ago I wasn’t involved in anything outside of my own neighborhood… How did I get here?”.

I think it was just a feeling that I had something to say, and I said it, and damn anyone who might try to belittle it. Including you, industry representative on the aisle who gave me that sour look as I walked back to my chair. I understand that companies want to advocate for what’s in their best interests. Well, that’s what I was doing too. Advocating for what is best for me as a patient. I understand and respect their concerns, but when they clash with what I need and deserve as a patient, I’m going to advocate for me and not be sheepish about it.

In the final assessment, I can say it was a day in which I was able to learn a lot, meet new people, and share my needs with the federal agency that plays such a big role in our lives. All of that made it well worth losing a little sleep and schlepping to D.C. in the dark. The timing (November 13) made it feel like an early World Diabetes Day gift.

Interoperability Awareness.

I’ve been living with Type 1 Diabetes for 23 years.

Like everyone else who was diagnosed with Type 1 around the time I was (1991), there were just a few options. Those options included, thankfully by then, glucose meters that gave us a reading from a drop of blood we provided. We used the data from those meters as a base for our dietary decisions and our insulin dosing. Also, as a basis for the imagined success or failure of our diabetes management.

Today, with little exception, we’re using the same system. The tools are better, probably more accurate, but we’re using the same system. Whether we’re using a continuous glucose monitor, an insulin pump, a Low Glucose Suspend system, or something else, we’re still using the same drop of blood to guide our decision-making process and the decision-making process of the systems we use.

And that’s okay, except it’s not, because we still can’t get what that drop of blood, or that CGM, or that insulin pump, or that LGS system is doing to work all on the same platform, informing the same data sources. That holds us up from sharing our data with our families (I’m familiar with Nightscout—I’m talking about all of our data). It keeps me from informing healthcare professionals on a real-time basis, at regular appointment times and if, God forbid, I wind up in the emergency room unable to speak for myself. It keeps researchers from being able to use my data to inform and support their discoveries. It keeps the diabetes devices that I wear from working efficiently, keeping me from achieving better outcomes with less effort. I’m talking big picture here: Not just “Can my CGM talk to my pump?”. I mean “Can my meter readings and CGM graphs and pump settings and prescription dosage and anything else health-related reside in one space?”.

Let’s face it: We’re now talking about cars that can drive themselves and using drones to deliver packages to our homes. Meanwhile, our diabetes devices are still dependent on years-old technology that is mostly confined within the length, breadth, and depth of the device itself.

If my data is all available via one source, where I control who can see it, but once I make it available, it’s easily accessible? That’s the jackpot in this discussion. And guess what? If that ever happens, I’m still going to want an insulin pump. I’m still going to want a CGM. I’m not going away as a customer.

To talk about the proprietary nature of software that a company has developed just doesn’t hold water anymore. The software that comes with your device doesn’t have a separate line item on the invoice. It’s baked into the price. Protecting “intellectual property rights”, in this case, is a 20th Century complaint for a 21st Century world. And it’s an 18th Century argument when it comes to what is best for the patient. I’ve said it before, and I mean it: Patient trumps Proprietary.

People With Diabetes need and are deserving of 21st Century technology that will not only help us reach better outcomes, but will help everyone who helps us reach better outcomes. Please join me in speaking out for greater awareness, and improved access to our data.
Tomorrow I’ll be attending the U.S. Food and Drug Administration’s Public Workshop – Regulatory Science Considerations for Software Used in Diabetes Management.

This is the message I’m taking with me.

May #DSMA Blog Carnival: People trump Proprietary.

The May DSMA Blog Carnival topic has required a lot of thought on my part. And to be honest, I’m not through thinking about it yet:

This is a grassroots initiative calling for diabetes data and device interoperability — so that we PWDs have full access to our own data, can share it as we like, and can use on whatever apps or platforms we choose without being locked into some proprietary product from just one manufacturer. For the month of May, we’d like to know:

Why does open D-data & device interoperability matter to you? How might your life improve if open data were the norm?

I originally wrote about this in a story about an interoperability conference I attended back in February.

To me, the problem with “proprietary” software (or “proprietary” anything else, for that matter) is the very ideal of proprietary: To continue sole ownership of and profit from a device, or an algorithm, or something else, forever. Or at least until the next proprietary thing can be developed that will replace the original. By nature, something proprietary is designed to be kept proprietary by its owner not just now… but for generations to come. Never ever shared.

But these companies paid for their product to be developed, right? They should be allowed to profit from it, as much as they want, right? Who am I to suggest they open up their code?

I’m all for profit. I love profit. Proprietary and profit go together like bacon and eggs.

Unless you keep kosher. And there’s the rub with “proprietary”.

Not everyone is the same. Some of the people in the world are blessed with bodies that have fully functioning pancreases. Some are not, and they are People With Diabetes.

Some People With Diabetes are blessed with wonderful insurance plans that pick up a large part of the cost for a new insulin pump, continuous glucose monitor, or test strips. Some are not, and they struggle to afford even the daily insulin they need to survive.

Some people never have to worry about where their blood glucose is headed at any given time. But there are People With Diabetes who deal with hypoglycemic unawareness, something that keeps them from being able to recognize life-threatening lows and treat them in time. For these people, a continuous glucose monitor, the best one they can lay their hands on, is a daily life-saving instrument that they cannot do without.

Some people are lucky enough to have access to world-class healthcare resources, where doctors and nurses can look over them whenever necessary to help them manage those times when they might wind up in the hospital. And some people wind up in the emergency room, waiting desperately for care, because the hospital they have access to still writes down every last statistic about every patient, then manually enters all of that data into a computer, then photocopies the paperwork and files it away in a vault somewhere… instead of accessing a standard system that includes all of the patient’s medical history, their prescriptions and doses, pump and CGM data, and their doctor information, leaving doctors and nurses free to, you know, actually practice medicine.

The thing that profit-protectors fear, I think, is that we’ll suddenly go away as customers the minute they open up their platforms. But here’s the thing: I would still want to wear an insulin pump. People would still want CGMs to monitor their blood glucose. I’m going to need insulin as long as I live with Type 1 Diabetes.

Your customers are not going away, profit-protectors. But… How would the lives of both groups of people described here be changed, if the standard of medical software development was focused on the patient… No—On all patients? What other discoveries (and sources for profit) could be discovered by playing with the rest of the kids in the sandbox and making people healthier?

Understand me: Profit is great… capitalism is a good thing. But not at the expense of any of my fellow People With Diabetes. People trump proprietary every time. But don’t fear, profiteers. Open platform or not, your products, and your customers, are not going away anytime soon.
This post is my May entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at http://diabetescaf.org/2014/05/may-dsma-blog-carnival-4/

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