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Wearables Makers Pitching Health Trackers For Babies

Posted on November 9, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

When my older son was born, we relied on a low-tech “sense of hearing” solution to track crying alerts from his crib at the other end of the hallway.

But were he born today, my son would never have settled for such pedestrian technology. Today’s discriminating newborn expects his parents to collect a wide array of data points and conduct advanced analytics on them to optimize his health.

You think this is ridiculous? Wipe that smile off of your face, you slackers. Ever sensitive to the expanding needs of today’s modern baby, wearables manufacturers have begun testing health trackers designed to monitor their tiny bodies, according to an article appearing on the CNN.com site.

In fact, there are already dozens of wearables for babies on the market, CNN found, including devices that monitor their heart rate, smart socks that track oxygen levels and a baby monitor button that snaps onto the child’s clothes. Any of these could cost a few hundred dollars. But there’s also smart thermometers and pacifiers, such as Vick’s or Blue Maestro’s Pacif-i, which start around $20 and go up from there, the site reports.

The CNN article also shares the tale of Crystal King, an Atlanta mom who’s monitoring her six-month son Avery using one of these emerging trackers.

The piece describes how using her cell phone, King can check her baby’s temperature on her cell phone and get app-driven alerts when it’s time for Avery’s next bottle feeding.

Meanwhile, if King picks up her tablet, she can also monitor her son’s breathing, body position, skin temperature and sleeping schedule. (Back in the Stone Age, I had to settle for keeping his body in position with pillow wedges and tracking his sleeping schedule using a little trick known as “staying awake.”)

As part of his work with CNN, Avery has been testing a number of different wearable devices. He seems to be a tough critic. On the one hand, he seemed pretty comfy wearing a biometric-tracking onesie while playing on his mat, but kept spitting out the smart pacifier, which was apparently a nonstarter.

Of course, we don’t actually know what Avery thinks about these devices, but his mom has developed some ideas. For example, King told CNN she thinks it would be good to help parents control the number of notifications they get from baby-monitoring apps and technologies.

If nothing else, equipping their baby with a health tracker may offer parents a little extra reassurance that their child is safe. He might still erupt in deafening screams at 3AM now and again, but if he’s wearing a health tracker, you might at least know why.

Alert Fatigue: It May Be Worse Than You Thought

Posted on November 3, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Until recently, I didn’t take the problem of clinical decision alert fatigue that seriously, or at least not as seriously as I should have. After all, it’s just an alert, right? You can just shut it off if you don’t like hearing it. Or so it seemed to me, admittedly a naïve pundit from the peanut gallery who’s never treated a patient in her life.

But despite my ignorance, researchers have continued to unearth evidence that alert fatigue may be one of the worst safety hazards afflicting medicine today. After all, this fatigue comes from a deadly one-two punch: the excess noises camouflage the alerts clinicians really need to hear while distracting them from what they’re doing with useless sounds. (If you put me in a situation like that I’d get booted out the door for throwing particularly noisy devices out the window.)

Sadly, alert fatigue is far more than a nuisance. The latest evidence to this effect comes from the Journal of the American Medical Informatics Association, where an article published last month underscored how often alerts cause clinicians to ignore important information.

To conduct their study, a group of researchers conducted a cross-sectional study of medication-related clinical decision support alerts. They collected data at a 793-bed tertiary-care teaching institution, measuring the rate of alert overrides, the reasons cited for overrides and the appropriateness of those reasons.

The results of their analysis were disquieting. On the one hand, they found that roughly 60% of overrides were appropriate overall. In particular, 98% of duplicate drug overrides, 96.5% of patient allergy overrides and 82.5% of formulary substitution overrides were appropriate. That’s the good news. On the other hand, they concluded that 40% of physician alert overrides were inappropriate.

All told, overrides of alerts in certain categories were inappropriate greater than 75% of the time. Let’s take a moment to think about that. Seventy. Five. Percent. Now, I know that “inappropriate” doesn’t mean that the patient would’ve died if the error was corrected, or even that they incur serious harm, but this still isn’t great to hear.

Not surprisingly, researchers said that future studies should optimize alert types and frequencies to improve their clinical relevance so clinicians don’t slap them down over and over like a snooze alarm.

The truth is, studies have been drawing this conclusion for quite some time now, and from what I can see little has changed here.

My assumption is that vendors keep doing what they do because nobody has pressured them enough to make them rethink their CDS logic and drop needless alarms. I’m also guessing that some misinformed health leaders might be reassured by the sound of alerts going on and equating it with higher safety ratings. If so, let’s hope they get disabused of this notion soon.

IBM Works To Avoid FDA Oversight For Its Watson Software

Posted on October 25, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I live in DC, where the fog of politics permeates the air. Maybe that’s given me more of a taste for political inside baseball than most. But lest the following story seems to fall into that category, put that aside – it actually involves some moves that could affect all of us.

According to Stat News, IBM has been lobbying hard to have its “cognitive computing” (read: AI) superbrain Watson exempt from FDA oversight. Earlier this year, eight of its employees were registered to lobby Congress on this subject, the site reports.

Through its Watson Health subsidiary, IBM has joined the crowded clinical decision support arena, a software category which could face FDA regulation soon.

Historically, the agency has dragged its heels on issuing CDS review guidelines. In fact, as of late last year, one-third of CDS developers were abandoning product development due to their uncertainty about the outcome of the FDA’s deliberations, according to a survey by the Clinical Decision Support Alliance.

Now, the agency is poised to issue new guidelines clarifying which software types will be reviewed and which will be exempt under the provisions of the 21st Century Cures Act. Naturally, IBM wants Watson to fall into the latter category.

According to Stat News, IBM spent $26.4 million lobbying Congress between 2013 and June 2017. While IBM didn’t disclose how much of that spent on the CDS regulation issue, it did tell the site that it was “one of many organizations, including patient and physician groups, that supported a common sense regulatory distinction between low-risk software and inherently higher-risk technologies.”

IBM also backed a bill known as the Software Act, which was opposed by the FDA office in charge of device regulation but backed enthusiastically by many software makers. The bill, which was first introduced in 2013, specified that health software would be exempted from FDA regulation unless it provided patient-specific recommendations and posed a significant risk to patient safety. It didn’t pass.

Now, executives with the computing giant will soon learn what fruit their lobbying efforts bore. The FDA said it intends to issue guidance documents explaining how it will implement the exemptions in the 21st Century Cures Act during the first quarter of next year.

No matter what direction it takes, the new FDA guidance is likely to be controversial, as key regulatory language in the 21st Century Cures Act remains open to interpretation. The law includes exemptions for advisory systems, but only if it’s they allow “health care professional to independently review the basis for such recommendations.”  Lawyers representing software makers told Stat News that no one’s sure what the phrase “independently review the basis” means, and that’s a big deal.

Regardless, it’s the FDA’s job to figure out what key provisions in the new law mean. In the meantime, waiting will be a bit stressful even for giants like IBM. Big Blue has made a huge bet on Watson Health, and if the FDA doesn’t rule in is favor, it might need a new strategy.

Mercy Shares De-Identified Data With Medtronic

Posted on October 20, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Medtronic has always performed controlled clinical trials to check out the safety and performance of its medical devices. But this time, it’s doing something more.

Dublin-based Medtronic has signed a data-sharing agreement with Mercy, the fifth largest Catholic health system in the U.S.  Under the terms of the agreement, the two are establishing a new data sharing and analysis network intended to help gather clinical evidence for medical device innovation, the company said.

Working with Mercy Technology Services, Medtronic will capture de-identified data from about 80,000 Mercy patients with heart failure. The device maker will use that data to explore real-world factors governing their response to Cardiac Resynchronization Therapy, a heart failure treatment option which helps some patients.

Medtronic believes that the de-identified patient data Mercy supplies could help improve device performance, according to Dr. Rick Kuntz, senior vice president of strategic scientific operations with Medtronic. “Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understanding how those devices perform outside of controlled clinical trial setting,” said Kuntz in a prepared statement.

Mercy’s agreement with Medtronic is not unique. In fact, academic medical centers, pharmaceutical companies, health insurers and increasingly, broad-based technology giants are getting into the health data sharing game.

For example, earlier this year Google announced that it was expanding its partnerships with three high-profile academic medical centers under which they work to better analyze clinical data. According to Healthcare IT News, the partners will examine how machine learning can be used in clinical settings to sift through EMR data and find ways to improve outcomes.

“Advanced machine learning is mature enough to start accurately predicting medical events – such as whether patients will be hospitalized, how long they will stay, and whether the health is deteriorating despite treatment for conditions such as urinary tract infections, pneumonia, or heart failure,” said Google Brain Team researcher Katherine Chou in a blog post.

As with Mercy, the academic medical centers are sharing de-identified data. Chou says that offers plenty of information. “Machine learning can discover patterns in de-identified medical records to predict what is likely to happen next, and thus, anticipate the needs of the patients before they arise,” she wrote.

It’s worth pointing out that “de-identification” refers to a group of techniques for patient data protection which, according to NIST, include suppression of personal identifiers, replacing personal identifiers with an average value for the entire group of data, reporting personal identifiers as being within a given range, exchanging personal identifiers other information and swapping data between records.

It may someday become an issue when someone mixes up de-identification (which makes it quite difficult to define specific patients) and anonymization, a subcategory of de-identification whereby data can never be re-identified. Such confusion would, in short, be bad, as the difference between “de-identified” and “anonymized” matters.

In the meantime, though, de-identified data seems likely to help a wide variety of healthcare organizations do better work. As long as patient data stays private, much good can come of partnerships like the one underway at Mercy.

New Research Identifies Game-Changing Uses For AI In Healthcare

Posted on June 27, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

In recent times, the use of artificial intelligence technology in healthcare has been a very hot topic. However, while we’ve come tantalizingly close to realizing its promise, no application that I know of has come close to transforming the industry. Moreover, as John Lynn notes, healthcare organizations will not get as much out of AI use if they are not doing a good job of working with both structured and unstructured data.

That being said, new research by Accenture suggests that those of us dismissing AI tech as immature may be behind the curve. Researchers there have concluded that when combined, key clinical health AI applications could save the US healthcare economy as much $150 billion by 2026.

Before considering the stats in this report, we should bear Accenture’s definition of healthcare AI in mind:

“AI in health presents a collection of multiple technologies enabling machines to sense, comprehend, act and learn, so they can perform administrative and clinical healthcare functions…Unlike legacy technologies that are only algorithms/tools that complement a human, health AI today can truly augment human activity.”

In other words, the consulting firm sees AI as far more than a data analytics tool. Accenture analysts envision an AI ecosystem that transforms and serves as an adjunct to the many healthcare processes. That’s a pretty ambitious take, though probably not a crazy one.

In its new report, Accenture projects that the AI health market will reach $6.6 billion by 2021, up from $600 million in 2014, fueled by the growing number of health AI acquisitions taking place. The report notes that the number of such deals has leapt from less than 20 in the year 2012 to nearly 70 by mid-2016.

Researchers predict that the following applications will generate the projected $150 billion in savings/value:

  • Robot-assisted surgery: $40 billion
  • Virtual nursing assistants: $20 billion
  • Administrative workflow assistance: $18 billion
  • Fraud detection: $17 billion
  • Dosage error reduction: $16 billion
  • Connected machines: $14 billion
  • Clinical trial participant identifier: $13 billion
  • Preliminary diagnosis: $5 billion
  • Automated image diagnosis: $3 billion
  • Cybersecurity: $2 billion

There are a lot of interesting things about this list, which goes well beyond current hot topics like the use of AI-driven chatbots.

One that stands out to me is that two of the 10 applications address security concerns, an approach which makes sense but hadn’t turned up in my research on the topic until now.

I was also intrigued to see robot-assisted surgery topping the list of high-impact health AI options. Though I’m familiar with assistive technologies like the da Vinci robot, it hadn’t occurred to me that such tools could benefit from automation and data integration.

I love the picture Accenture paints of how this might work:

“Cognitive robotics can integrate information from pre-op medical records with real-time operating metrics to physically guide and enhance the physician’s instrument precision…The technology incorporates data from actual surgical experiences to inform new, improved techniques and insights.”

When implemented properly, robot-assisted surgery will generate a 21% reduction in length of hospital stays, the researchers estimate.

Of course, even the wise thinkers at Accenture aren’t always right. Nonetheless, the broad trends report identifies seem like reasonable choices. What do you think?

And by all means check out the report – it’s short, well-argued and useful.

Provider-Backed Health Data Interoperability Organization Launches

Posted on April 12, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

In 1988, some members of the cable television industry got together to form CableLabs, a non-proft innovation center and R&D lab. Since then, the non-profit has been a driving force in bringing cable operators together, developing technologies and specifications for services as well as offering testing and certification facilities.

Among its accomplishments is the development of DOCSIS (Data-over-Cable Service Interface Specification), a standard used worldwide to provide Internet access via a cable modem. If your cable modem is DOCSIS compliant, it can be used on any modern cable network.

If you’re thinking this approach might work well in healthcare, you’re not the only one. In fact, a group of powerful healthcare providers as just launched a health data sharing-focused organization with a similar approach.

The Center for Medical Interoperability, which will be housed in a 16,000-square-foot location in Nashville, is a membership-based organization offering a testing and certification lab for devices and systems. The organization has been in the works since 2011, when the Gary and Mary West Health Institute began looking at standards-based approaches to medical device interoperability.

The Center brings together a group of top US healthcare systems – including HCA Healthcare, Vanderbilt University and Community Health Systems — to tackle interoperability issues collaboratively.  Taken together, the board of directors represent more than 50 percent of the healthcare industry’s purchasing power, said Kerry McDermott, vice president of public policy and communications for the Center.

According to Health Data Management, the group will initially focus on acute care setting within a hospital, such as the ICU. In the ICU, patients are “surrounded by dozens of medical devices – each of which knows something valuable about the patient  — but we don’t have a streamlined way to aggregate all that data and make it useful for clinicians,” said McDermott, who spoke with HDM.

Broadly speaking, the Center’s goal is to let providers share health information as seamlessly as ATMs pass banking data across their network. To achieve that goal, its leaders hope to serve as a force for collaboration and consensus between healthcare organizations.

The project’s initial $10M in funding, which came from the Gary and Mary West Foundation, will be used to develop, test and certify devices and software. The goal will be to develop vendor-neutral approaches that support health data sharing between and within health systems. Other goals include supporting real-time one-to-many communications, plug-and-play device and system integration and the use of standards, HDM reports.

It will also host a lab known as the Transformation Learning Center, which will help clinicians explore the impact of emerging technologies. Clinicians will develop use cases for new technologies there, as well as capturing clinical requirements for their projects. They’ll also participate in evaluating new technologies on their safety, usefulness, and ability to satisfy patients and care teams.

As part of its efforts, the Center is taking a close look at the FHIR API.  Still, while FHIR has great potential, it’s not mature yet, McDermott told the magazine.

The Challenge of FDA Clearance

Posted on March 16, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

As I’ve talked to 100s of companies creating devices for healthcare, there’s inevitably the question: “Are you FDA cleared?” There answer usually tells me a lot about the company and what their goals are for the product. Generally, it’s a question of if they’re going to go after the consumer space (ie. no FDA clearance) or after the medical market (ie. FDA clearance preferred).

In a few cases, I’ve talked to companies like EarlySense that have an FDA cleared product for hospital beds and a non-FDA cleared product for consumers. It was interesting to hear the reasons why they chose to release a non-FDA cleared product for consumers since they already knew they had the capability to go through the FDA clearance process. Their answer to me was instructive.

The core of their response was that FDA clearance is not a one time event and so this limits their ability to iterate and release product updates.

For anyone working in the startup world, it runs completely counter to the startup culture. The idea of iterating quickly and often is part of the mantra of most startup companies in silicon valley and now around the world. The FDA’s clearance process runs almost completely counter to this idea.

With this type of restriction, it makes sense why so many companies would avoid FDA clearance and just create a direct to consumer product that doesn’t require FDA clearance. The ongoing FDA clearance requirements can be a bear. What company wouldn’t want to bypass it and just iterate as they please?

The challenge with this approach is that there are reasons that FDA clearance is so challenging. First, it searches to provide a level of safety as far as what’s being implemented and the results of the device actually being tested and confirmed. Second, it creates a trust that most doctors (and their malpractice and insurance companies) want to see before using it.

Certainly, we could argue about how effective the FDA clearance is about ensuring safety and results, but that’s a topic for another day. If nothing else, it requires many organizations to think deeply about what the safety of the patients that are impacted by the device and consider the promises they make to customers. Those are two things that are missing in my consumer health devices and apps.

It’s a tough balance and I don’t think we’ve fully figured it out. How do you ensure safety and efficacy while still allowing the entrepreneurial spirit of innovation to thrive?

AMA Approves List Of Best Principles For Mobile Health App Design

Posted on November 29, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

The American Medical Association has effectively thrown her weight behind the use of mobile health applications, at least if those apps meet the criteria members agreed on at a recent AMA meeting. That being said, the group also argues that the industry needs to expand the evidence base demonstrating that apps are accurate, effective, safe and secure. The principles, which were approved at its recent Interim Meeting, are intended to guide coverage and payment policies supporting the use of mHealth apps.

The AMA attendees agreed on the following principles, which are intended to guide the use of not only mobile health apps but also associated devices, trackers and sensors by patients, physicians and others. They require that mobile apps and devices meet the following somewhat predictable criteria:

  • Supporting the establishment or continuation of a valid patient-physician relationship
  • Having a clinical evidence base to support their use in order to ensure mHealth apps safety and effectiveness
  • Following evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care and positive health outcomes
  • Supporting data portability and interoperability in order to promote care coordination through medical home and accountable care models
  • Abiding by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app
  • Requiring that physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services, or will be providing these services is otherwise authorized by that state’s medical board
  • Ensuring that the delivery of any service via the app is consistent with the state scope of practice laws

In addition to laying out these principles, the AMA also looked at legal issues physicians might face in using mHealth apps. And that’s where things got interesting.

For one thing, the AMA argues that it’s at least partially on a physician’s head to school patients on how secure and private a given app may be (or fail to be). That implies that your average physician will probably have to become more aware of how well a range of apps handle such issues, something I doubt most have studied to date.

The AMA also charges physicians to become aware of whether mHealth apps and associated devices, trackers and sensors are abiding by all applicable privacy and security laws. In fact, according to the new policy, doctors are supposed to consult with an attorney if they don’t know whether mobile health apps meet federal or state privacy and security laws. That warning, while doubtless prudent, must not be helping members sleep at night.

Finally, the AMA notes that there are still questions remaining as to what risks physicians face who use, recommend or prescribe mobile apps. I have little doubt that they are right about this.

Just think of the malpractice lawsuit possibilities. Is the doctor liable because they relied on inaccurate app results collected by the patient? If the app they recommended presented inaccurate results? How about if the app was created by the practice or health system for which they work? What about if the physician relied on inaccurate data generated by a sensor or wearable — is a physician liable or the device manufacturer? If I can come up with these questions, you know a plaintiff’s attorney can do a lot better.

How IRIS Puts the Real Triple Aim of Healthcare In Action

Posted on November 22, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

As I’ve been doing my Fall Healthcare IT Conference tour, I’ve had the chance to meet with hundreds of companies and thousands of people working to improve healthcare. While all this travel takes its toll, I also come away from all of these meetings invigorated by the quality of people and their desire to make healthcare better. That’s true almost across the board.

While most of the solutions I see are an evolution of something I’ve seen before, every once in a while I meet with a company that’s really impacting healthcare in a unique and interesting way. I found just such a case when I met with Patrick Cresson from IRIS – Intelligent Retinal Imaging Systems.

On face value, many might look at IRIS as just another diabetic retinopathy exam that’s been done by ophthalmologists forever. While this is true, what makes IRIS unique is that they have an FDA cleared exam that can be done in the primary care setting as opposed to being referred to an ophthalmologist. As Patrick pointed out to me, of all the diabetic screenings that need to be done for diabetic patients can be done in the primary care setting except for the retinal exam. At least that was the case before IRIS brought those exams to the primary care setting.

A look at the numbers is quite telling. There are 116 million patients with diabetes or pre-diabetes and that number is increasing every day. It’s estimated that 30 million diabetes patients get referred for an eye exam every year and 19 million diabetes patients do not get the annual retinal exam. There are plenty of reasons why this is the case, but it’s not hard to see why this happens. The same thing happens with referrals across healthcare. Diabetic patients that can’t tell any difference in their eyesight are unlikely to keep going back for an annual retinal exam. Who really wants to go to the pain of scheduling an appointment for what doesn’t seem to be an issue? So, they don’t.

The problem with this thinking is that diabetic retinopathy is asymptomatic. The only way to know if you’re heading for trouble is to have a retinal exam. The good news is that early detection can solve the problem and literally save diabetic patients’ eyesight. I know this first hand since it saved my grandfather’s eyesight.

This is the compelling story that IRIS tells as it pushes the retinal exam into the primary care setting where they can ensure patients are getting the early screenings they’ve so often missed in the past. This plays out in the numbers. Over the past 3 years, IRIS has performed 120,000 diabetic retinopathy exams which resulted in 56,000 patients identified with a pathology and 11,600 patients saved from potential blindness.

While this type of early detection can help healthcare organizations HEDIS compliance, I’m intrigued by the way IRIS straddles the fee for service and value based care worlds. I’ve seen very few models that get a primary care provider paid in the fee for service world, but also work to significantly lower the costs of healthcare in a value based care world. However, that’s exactly what you get from IRIS’s early screening exams.

What’s also fascinating to consider about IRIS is ophthalmologists’ response. It’s easy to see how many ophthalmologists could be afraid of diabetic retinal exams being done in the primary care setting and not in the ophthalmologists’ offices. That’s taking business away from them. While this is true, it’s also easy to see how an increase in retinal exams will drive more previously undiagnosed higher acuity exams, surgeries and interventions to ophthalmologists. Every ophthalmologist I know would much rather do a higher acuity surgery than a basic diabetic retinopathy exam. That’s the reality that IRIS creates since it’s an FDA cleared exam for diabetic retinopathy, but it’s only a screening tool for other eye diseases that require a full exam by an ophthalmologist.

Stories like IRIS are why I love blogging about healthcare IT. IRIS is changing healthcare as we know it by reducing healthcare costs, improving the patient experience, and getting doctors paid. That’s the real triple aim of healthcare in action.

FDA Under Pressure To Deliver Clinical Decision Support Guidelines

Posted on November 10, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

The world of clinical decision support technologies may change soon, as the FDA may soon be releasing guidelines on how it will regulate such technology. According to a new report in Politico, the agency has been working on such guidelines since 2011, but it’s not clear what standards it will use to establish these rules.

Software vendors in the CDS business are getting antsy. Early this year, a broad-based group known as the Clinical Decision Support Coalition made headlines when it challenged the agency to clarify the scope of CDS software it will regulate, as well as what it will require from any software that does fall under its authority.

At the time, the group released a survey which found that one-third of CDS developers were abandoning CDS product development due to uncertainty around FDA regulations. Of CDS developers that were moving ahead despite the uncertainty, the only two-thirds were seeing significant delays in development, and 20% of that group were seeing delays of greater than one year.

The delay has caught the attention of Congress, where Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) have filed the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, legislation designed to resolve open questions around CDS software, but the problem still remains.

The FDA has had a research project in place since late 2014 which is creating and evaluating a CDS system for safe and appropriate use of antibiotics. The researcher-developed system generates alerts when a provider prescribes an antibiotic that poses a risk of serious cardiac adverse events for specific patients. Two of the 26 hospitals in the Banner Health network are participating in the study, one of which will use the system and the other which will not. The results aren’t due until April of next year.

It’s hard to say what’s holding the FDA up in this case, particularly given that the agency itself has put CDS guidance on his list of priority projects. But it could be a simple case of too much work and too few staff members to get the job done. As of late last year, the agency was planning to fill three new senior health scientist positions focused on digital health, a move which could at least help it keep up with the flood of new health technologies flooding in from all sides, but how many hours can they work?

The truth is, I’d submit, that health IT may be moving too quickly for the FDA to keep up with it. While it can throw new staff members at the problem, it could be that it needs an entirely new regulatory process to deal with emerging technology such as digital health and mobile device-based tools; after all, it seems to be challenged by dealing with CDS, which is hardly a new idea.