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E-Patient Update: Patient-Doctor Communication Still Needs an Update

Posted on December 2, 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.

A few weeks ago, I called my PCP’s after-hours line to address an urgent medical concern. The staff at the answering service took my name, reached out to the doctor on call and when he was ready, connected him to me.

While this procedure was entirely standard, as always I found it a bit offputting, as to me it implies that I can’t be trusted to use the doctor’s cell phone number with some discretion. Don’t get me wrong, part of me understands why the doctors in this practice preferred to preserve their privacy and select when they want to speak to patients. On the other hand, however, it makes me uneasy, as I already have a very superficial relationship with my PCP and this approach doesn’t help.

While this is very much an old-school problem, to me it points to a larger one which has largely gone unnoticed as we plunge forward with the evolution of health IT. In theory, we are living in a far more connected world, one which puts not only family and friends but the professionals we work with on far more of a one-to-one basis with us. In practice, however, I continue to feel that patient-doctor communication has benefited from this far less than one might think.

I know, you’re going to point out to me how many doctors are using portals to email with patients these days, and how some even text back and forth with us. I’ve certainly been lucky enough to benefit from the consideration of providers who have reached out via these channels to solve urgent problems. And I know some health organizations — such as Kaiser Permanente — have promoted a culture in which doctors and patients communicate frequently via its portal.

The thing is, I think Kaiser’s experience is the exception that proves the rule. Yes, my doctors have indeed communicated with me directly via portals or cell. But the email and text messages I’ve gotten from them are typically brief, almost pointillistic, or if longer and more detailed, typically written days or even weeks after the original request on my end. In other words, these communications aren’t a big improvement over what they could accomplish with an old-fashioned phone call – other than being asynchronous communication that doesn’t require we hook up in real-time.

In saying this, I’m not faulting the clinicians themselves. Nobody can communicate with everyone all the time, particularly doctors with a large caseload. And I’m certainly not suggesting that I expect them to be Facebook buddies with me and chat about the weather. But it is worth looking at the way in which these communication technologies have seemingly failed to enrich the communication between patient and doctor in many cases.

Until we develop a communication channel for patients and doctors which offers more of the benefits of real-time communication — while helping doctors manage their time as they see fit — I think much of the potential of physician-patient communication by Internet will be wasted. I’m not sure what the solution is, but I do hope we find one.

OIG Says HHS Needs To Play Health IT Catch-Up

Posted on December 1, 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.

A new analysis by the HHS Office of the Inspector General suggests that the agency still has work to do and appropriately managing health information technology and making sure it performs, according to Health Data Management. And unfortunately, the problems it highlights don’t seem likely to go away anytime soon.

The critique of HHS’s HIT capabilities came as part of an annual report from the OIG, in which the oversight body lists what it sees as the department’s top 10 management and performance issues. The OIG ranked HIT third on its list.

In that critique, auditors from the OIG pointed out that there are still major concerns over the future of health data sharing in the US, not just for HHS but also in the US healthcare system at large. Specifically, the OIG notes that while HHS has spent a great deal on health IT, it hasn’t gotten too far in enabling and supporting the flow of health data between various stakeholders.

In this analysis, the OIG sites several factors which auditors see as a challenge to HHS, including the lack of interoperability between health data sources, barriers imposed by federal and state privacy and security laws, the cost of health IT infrastructure and environmental issues such as information blocking by vendors. Of course, the problems it outlines are the same old pains in the patoot that we’ve been facing for several years, though it doesn’t hurt to point them out again.

In particular, the OIG’s report argues, it’s essential for HHS to improve the flow of up-to-date, accurate and complete electronic information between the agency and providers it serves. After all, it notes, having that data is important to processing Medicare and Medicaid payments, quality improvement efforts and even HHS’s internal program integrity and operations efforts. Given the importance of these activities, the report says, HHS leaders must find ways to better streamline and speed up internal data exchange as well as share that data with Medicare and Medicaid systems.

The OIG also critiqued HHS security and privacy efforts, particularly as the number of healthcare data breaches and potential cyber security threats like ransomware continue to expand. As things stand, HHS cybersecurity shortfalls abound, including inadequacies and access controls, patch management, encryption of data and website security vulnerabilities.  These vulnerabilities, it noted, include not only HHS, but also the states and other entities that do business with the agency, as well as healthcare providers.

Of course, the OIG is doing its job in drawing attention to these issues, which are stubborn and long-lasting. Unfortunately, hammering away at these issues over and over again isn’t likely to get us anywhere. I’m not sure the OIG should have wasted the pixels to remind us of challenges that seem intractable without offering some really nifty solutions, or at least new ideas.

Accountable Care HIT Spending Growing Worldwide

Posted on November 30, 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.

A new market research report has concluded that given the pressures advancing the development of accountable care models, the market for solutions serving ACOs should expand worldwide, though North America is likely to lead the segment for the near future.

The report, by research firm Markets & Markets, covers a wide range of technologies, including EHRs, healthcare analytics, HIE, RCM, CDSS, population health, claims management and care management. It also looks at delivery mode, e.g. on premise, web and cloud and end-user, which includes providers and payers. So bear that in mind when you look at these numbers. That being said, providers accounted for the largest share of this niche last year, and should see the highest growth in the sector over the next five years.

Broadly speaking, Markets & Markets reports that the accountable care solutions market grew a healthy growth rate during the last decade. Researchers there expect to see this market grow at a CAGR of 16.6% over the next five years, to hit $18.86 billion by 2021.

When it comes to leaders in the sector, researchers identify Cerner, IBM, Aetna and Epic as leaders in the current ACO solutions market and probable future winners between 2016 and 2021. Other major players in the space include UnitedHealth Group, Allscripts, McKesson, Verisk Health, Zeomega, eClinicalWorks and NextGen. Given how broadly they define this category, I’m not sure how important this is, but there you have it.

According Markets & Markets, the growth of the ACO solutions market worldwide is due to forces we know well, including shifting government regulations, the rollout of initiatives shifting financial risk from payers to providers, the demand to slow down healthcare cost increases in the advance of IT and big data capabilities. (Personally, I’d add the desire of health systems – ACO-affiliated or not – to differentiate themselves by performing well at the population health level.)

If your view is largely US-centric, as is mine, you might be interested to note that the trend towards ACO-like entities in the Asia-Pacific and Latin American regions is expanding, the researchers report. Most specifically, Markets & Markets researchers found that there is notable growth occurring in Asian countries, which, it reports, are modifying regulations and monitoring the implementation of procedures, policies and guidelines to promote innovation and commercialization. This has led to an increasing number of hospitals and academic institutions interested in the sector, along with a government focus on implementing health IT solutions and infrastructure – factors likely to generate an expanding ACO solutions market there.

After reading all of this, the question I’m left with is whether there’s any point in differentiating an “ACO” specific player as these researchers have. Maybe I’m playing with words too much hear, but wouldn’t it be more accurate to say that the definition of health system infrastructure is evolving, whether it’s part of an ACO as such or not?

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.

E-Patient Update: Time To Share EMR Data With Apps

Posted on November 18, 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.

Like most Americans, I’ve used many a health-related app, in categories including vitals tracking, weight control, sleep management, medication management and exercise tracking. While I’ve continued to use a few, I’ve dropped most after a few uses because they didn’t contribute anything to my life.

Now, those of you who are reading this might assume that I lost interest in the apps because they were poorly designed. I admit that this was true in some cases. But in others, I’ve ceased to use the apps because the data they collect and display hasn’t been terribly useful, as most of it lives in a vacuum. Sure, I might be able to create line graph of my heart rate or pulse ox level, but that’s mildly interesting at best. (I doubt physicians would find it terribly interesting either.)

That being said, I believe there is a way healthcare organizations can make the app experience more useful. I’d argue that hospitals and clinics, as well as other organizations caring for patients, need to connect with major app developers and synch their data with those platforms. If done right, the addition of outside data would enrich the patient experience dramatically, and hopefully, provide more targeted feedback that would help shape their health behaviors.

How it would work

How would this work? Here’s an example from my own life, as an e-patient who digitally manages a handful of chronic, sometimes-complex conditions.

I have tested a handful of medication management apps, whose interfaces were quite different but whose goals seem to be quite similar — the primary one being to track the date and time each medicine on my regimen was taken. In each case, I could access my med compliance history rather easily, but had no information on what results my level of compliance might have accomplished.

However, if I could have overlaid those compliance results with changes in my med regimen, changes in my vital signs and changes in my lab values, I have a better picture of how all of my health efforts fit together. Such a picture would be far more likely to prompt changes in my health behavior than uncontextualized data points based on my self-report alone.

I should mention that I know of at least one medication management app developer (the inspiration for this essay) which hopes to accomplish just this result already, and is hard at work enriching its platform to make such integration possible. In other words, developers may not need much convincing to come on board.

The benefits of added data

“Yes,” I hear you saying, “but why should I share my proprietary data?” The answer is fairly simple; in the world of value-based reimbursement, you need patients to get and stay well, and helping them better manage their health fits this goal.

Admittedly, achieving this level of synchronization between apps and provider data won’t be simple. However, my guess is that it would be easier for app developers to import, say, pharmacy or EMR data than the other way around. After all, app platforms aren’t at the center of nearly as many overlapping data systems as a health organization or even a clinic. While they might not be starting from zero, they have less bridges to build.

And once providers have synchronized key data with app developers, they might be able to forge long-term partnerships in which each side learned from the exchange. After all, I’d submit that few app developers would turn up the chance to make their data more valuable — at least if they have bigger goals than displaying a few dots on a smartphone screen.

I realize that for many providers, doing this might be a tall order, as they can’t lose their focus on cultivating their own data. But as a patient, I’d welcome working with any provider that wanted to give this a try. I think it would be a real win-win.

AMA Urges Med Schools To Cover Health IT Basics

Posted on November 17, 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.

Despite the nearly universal use of health IT tools in medical practice today, the majority of med students make it through their medical school experience without having much exposure to such tools. In an effort to change this, the AMA is launching a new textbook designed to give med students at least a basic exposure to critical health IT topics.

To create the textbook, the AMA collaborated with its 32-school Accelerating Change in Medical Education Consortium. The collaboration generated a new “pillar” of medical education it dubs Health Systems Science, which members concluded should be taught alongside of basic and clinical sciences. This follows a recent study by the AMA concluding that its practicing physician members are quite interested in digital health.

In addition to covering key business concepts such as value in healthcare, patient safety, quality improvement, teamwork/team science and leadership, socio-ecological determinants of health, healthcare policy and health care economics, the textbook also addresses clinical informatics and population health.  And an AMA press release notes that many schools within the Consortium will soon use the textbook with the students, including Penn State College of Medicine and Brown University’s Warren Alpert Medical School.

The Brown program, for example, which received a $1 million AMA grant to support the change in this curriculum, has created a Primary Care-Population Medicine program. The program awards graduates both a Doctor of Medicine and a Master of Science in Population Medicine. The AMA describes this program is the first of its kind in the US.

It’s interesting to see that the AMA has stepped in and funded this project, partly because it seems to have been ambivalent about key health IT tools in the past, but partly because I expect to see vendors doing something like this. Honestly, now that I think about it, I’m surprised there isn’t a Cerner grant for the most promising clinical informatics grad, say, or the eClinicalWorks prize sponsoring a student’s medical training. Maybe the schools have rules against such things.

Actually, this is a rare situation in which I think getting vendors involved might be a good idea. Of course, med students wouldn’t benefit particularly from being trained exclusively on one vendor’s interface, but I imagine schools could organize regular events in which med school students had a chance to learn about different vendors’ platforms and judge the strengths and weaknesses of each on their own.

I guess what I’m saying is that while obtaining an academic understanding of health IT tools is great, the next step is to have med students get their hands on a wide variety of health IT tools and play with them before they’re on the front lines. That being said, adding pop health any clinical informatics is a step in the right direction

Portals May Not Reduce Calls To Medical Practices

Posted on November 16, 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.

Initially, patient portals were rolled out to give patients access to their core medical information, with the hope that a more educated patient would be more likely to take care of their health. Over time, features like appointment setting and the ability to direct-email providers were added, with some backers predicting that they would make practices more efficient. And since providers began rolling out nifty new interactive portals, anecdotes have piled up suggesting that they are delivering the goods.

However, a new study suggests that this might not be the case — or at least not always. The researchers behind the study, published in the Journal of the American Board of Family Medicine, had predicted that when patients got access to a full-featured portal, clinic staffers’ workload would be cut. But they did not achieve the results they had expected.

The researchers, who were from the Oregon Health & Science University in Portland, compared portal adoption rates and the number of telephone calls received at four clinics affiliated with a university hospital between February and June 2014.

They found that despite growing adoption rates of the portal at all four clinics, call volumes actually increased at two of the clinics, which included a commercial, community-based health center and a university-based health center. Meanwhile, call volume stayed level at the two other clinics, a rural health center and a federally-qualified health center. In other words, in no case did the volume of phone calls fall.

The researchers attempted to explain the results by noting that it might take a longer time than the study embraced for the clinics to see portals reduce their workload. Also, they suggested that while the portal didn’t seem to reduce calls, it might be offering less-concrete benefits such as increased patient satisfaction.

What’s more, they said, the study results might have been impacted by the fact that all four clinics were implementing a patient centered medical home model. They seemed to think that PCMH requirements for care coordination and quality improvement initiatives for chronic illness, routine screenings and vaccinations might have increased the complexity of the patients’ needs and encouraged them to phone in for help.

As I have noted previously, patients seldom see your portal the way you do. In that previous article, I described my largely positive — but still somewhat vexing – experience using the Epic MyChart portal as a patient. In that case, while I could access all of the data held within the health system behind the EMR pretty easily, getting the health system employees to integrate outside data was a hassle and a half.

In the case described in the study, it sounds like the portal may not have been designed with patient workflow in mind. With the practices rolling out a patient-centered medical home model, the portal would have to support patients in activities that went well beyond standard appointment setting and even email exchanges with clinicians. And presumably, it didn’t.

Bottom line, I think it’s good that this research has led to questions about whether portals actually make make medical practices more efficient. While there is plenty of anecdotal evidence suggesting that they do — so much that investing in portals still makes sense — it’s good to see questions about their benefits looked at with some rigor.

Healthcare Orgs Must Do Better With Mobile Data Security Education

Posted on November 15, 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.

A new study finds that while most healthcare professionals use mobile messaging at work, many aren’t sure what their organization’s mobile messaging policies are, and a large number have transmitted Protected Health Information via insecure channels. In other words, it seems that health IT leaders still have a lot of work to do in locking down these channels.

According to a report by Scrypt, 65% of health professionals who use a mobile device at work also use the same device for personal use, the standard BYOD compromise which still gives healthcare CIOs the willies. Underscoring the security risks, 52% of respondents said that they had free reign over which applications they downloaded and used at work.

To be fair, virtually all respondents (96%) use at least one security method to protect the security of their mobile device. However, their one-factor efforts — usually passcode or PIN-based — may not be secure enough to protect such sensitive data.

The research also blows the whistle on the frequency with which health professionals share PHI using a mobile messaging clients (not surprisingly given that the vendor sells a secure mobile messaging solution). It notes that just a quarter of those who reported using mobile messages use a secure client, and that one in five have sent or received PHI via mobile message with names (24%), telephone numbers (19%) and email addresses (13%) included in the content.

Researchers found that 78% of healthcare professionals use mobile messaging at work. However, few understand how their organizations expect them to use these services. Fifty-two percent of respondents who use mobile messaging said they didn’t know or weren’t sure of what their organization’s policies were on the subject.

Showing some awareness of data security vulnerabilities, 56% of the survey respondents said they believe the organization could do more to educate employees on the rules around sharing PHI and HIPAA compliance. On the other hand, it seems like most consider this to be everybody else’s problem, as 80% of respondents reported that their own knowledge of HIPAA compliance was either good or very good.

Clearly, as self-serving as the vendor’s conclusion is, they’re onto something important. Not only are CIOs facing huge challenges in establishing a smart BYOD policy, they’re confronted with a major educational problem when it comes to sharing of PHI. While the professionals on their team may have been handed a mobile policy, they may not have absorbed it. And if they haven’t been given a policy, you have to be conservative and assume they’re not doing a great job protecting data on their own.

If nothing else, healthcare organizations can remind their staff members to be careful when texting at work – heck, why not text them the reminder so it’s in context? Bottom line, even highly intelligent and educated team members can succumb to habit and transmit PHI. So a nudge never hurts!

E-Patient Update: Bringing mHealth To The People

Posted on November 11, 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.

Today, it’s standard for patients to travel to a central hub of some kind, spend as much as a half hour in the lobby and fill out a few minutes of paperwork to get a maximum of 15 minutes of time with their doctor. But thankfully, we’ve come to a time when care can return to the home. And it’s time we take full advantage of that fact.

I’d argue that it’s long overdue to bring the medical visit back to patient homes, not just for those in need of chronic care, but for all patients who are less than markedly stable. If we’re not quite at the point where we can provide every standard primary care service in a home, we’re pretty close, and it should be our goal to close the gap.

Consumers want convenience
While it might not be practical to roll out the service to everyone at once, we could start with patients who are healthy, but in higher risk categories due to age or condition. My mother comes to mind. At age 74, she has a history of cardiac arrhythmia, is slightly overweight and suffers from joint problems. None of these may pose an immediate risk to her health, but they are part of the complex process of aging for her, and all that goes with it.

I believe her health would be managed better if someone saw her “in her element,” taking care of my disabled brother, rushing around cooking dinner and climbing stairs. It would also be easier for clinicians to show her health information at her kitchen table, and get her engaged with making progress. (Kitchen tables are inherently less intimidating.)

Besides, there’s the issue of travel. Often, she finds it taxing to get organized and get to medical appointments, which take place 20 minutes away at the offices of her local health system. “I wish someone would bring a van with testing devices like an x-ray machine in it, bring their tablets into my house and do the check up at home,” she says. “There’s no reason for me to do all the traveling.” And believe me, folks, if a technophobe like my mom — who won’t touch a computer — is wondering why her physicians aren’t making better use of mobile healthcare tools, you can bet other patients are.

Mobile satisfaction
If you’re a health leader reading this, you may be flinching at the idea of reorganizing your services to hit the road. But it’s worth doing, particularly now that patients are demanding mobile health access. After all, rolling out a mobile-enhanced door to door primary care service would be an unbeatable way to differentiate yourself from your competitors and enhance patient satisfaction.

I believe that whatever investments you have to make would be modest in comparison to the benefits your patients would realize. If you come to them, not only are you getting to know them better, and as a result, you’re likely to improve care quality.

Now, I understand that if you’re traveling, you probably can’t pack four patient encounters into an hour, and that is certainly a financial consideration. But I believe patients would pay more to see their very own doctor (not a stranger, as with some startups) visit them at home. More importantly, I’d argue, a reworked system that puts patients at the center of their care would eventually save money, time and lives which is where value based reimbursement is headed anyway.

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.