Free EMR Newsletter Want to receive the latest news on EMR, Meaningful Use, ARRA and Healthcare IT sent straight to your email? Join thousands of healthcare pros who subscribe to EMR and EHR for FREE!

Some Methods For Improving EMR Alerts

Posted on June 25, 2015 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 appearing in the Journal of the American Medical Informatics Association has made some points that may turn out to be helpful in designing those pesky but helpful alerts for clinicians.

Making alerts useful and appropriate is no small matter. As we reported on a couple of years ago, even then EMR alert fatigue has become a major source of possible medical errors. In fact, a Pediatrics study published around that time found that clinicians were ignoring or overriding many alerts in an effort to stay focused.

Despite warnings from researchers and important industry voices like The Joint Commission, little has changed since then. But the issue can’t be ignored forever, as it’s a car crash waiting to happen.

The JAMIA study may offer some help, however. While it focuses on making drug-drug interaction warnings more usable, the principles it offers can serve as a model for designing other alerts as well.

For what it’s worth, the strategies I’m about to present came from a DDI Clinical Decision Support conference attended by experts from ONC, health IT vendors, academia and healthcare organizations.

While the experts offered several recommendations applying specifically to DDI alerts, their suggestions for presenting such alerts seem to apply to a wide range of notifications available across virtually all EMRs. These suggestions include:

  • Consistent use of color and visual cues: Like road signs, alerts should come in a limited and predictable variety of colors and styles, and use only color and symbols for which the meaning is clear to all clinicians.
  • Consistent use of terminology and brevity: Alerts should be consistently phrased and use the same terms across platforms. They should also be presented concisely, with minimal text, allowing for larger font sizes to improve readability.
  • Avoid interruptions wherever possible:  Rather than freezing clinician workflow over actions already taken, save interruptive alerts that require action to proceed for the most serious situation. The system should proactively guide decisions to safer alernatives, taking away the need for interruption.

The research also offers input on where and when to display alerts.

Where to display alert information:  The most critical information should be displayed on the alert’s top-level screen, with links to evidence — rather than long text — to back up the alert justification.

When to display alerts: The group concluded that alerts should be displayed at the point when a decision is being made, rather than jumping on the physician later.

The paper offers a great deal of additional information, and if you’re at all involved in addressing alerting issues or designing the alerts I strongly suggest you review the entire paper.

But even the excerpts above offer a lot to consider. If most alerts met these usability and presentation standards, they might offer more value to clinicians and greater safety to patients.

Is Meaningful Use For Mental Health Providers On The Way?

Posted on June 10, 2015 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.

If you look at the policy statements issued by ONC, it sounds as though the organization is a big fan of putting behavioral health IT on the same footing as other aspects of care. As the agency itself points out, 46% of Americans will have a mental health disorder over the course of their lifetime, and 26% of Americans aged 18 and older live with a mental health disorder in any given year, which makes it imperative to address such issues systematically.

But as things stand, behavioral health IT initiatives aren’t likely to go far. True, ONC has encouraged behavioral health stakeholders on integrating their data with primary care data, stressed the value of using EMRs for consent management, supported the development of behavioral health clinical quality measures and even offered vendor guidelines on creating certified EMR tech for providers ineligible for Meaningful Use. But ONC hasn’t actually suggested that these folks deserve to be integrated into the MU program. And not too surprisingly, given their ineligibility for incentive checks, few mental health providers have invested in EMRs.

However, a couple of House lawmakers who seem pretty committed to changing the status quo are on the case. Last week, Reps. Tim Murphy (R-Pa.) and Eddie Bernice Johnson (D-Texas) have reintroduced a bill which would include a new set of behavioral health and substance abuse providers on the list of those eligible for Meaningful Use incentives.

The bill, “Helping Families in Mental Health Crisis Act,” would make clinical psychologists and licensed social workers eligible to get MU payments. What’s more, it would make mental health treatment facilities, psychiatric hospitals and substance abuse mistreatment facilities eligible for incentives.

Supporters like the Behavioral Health IT Coalition say such an expansion could provide many benefits, including integration of psych and mental health in primary care, improved ability of hospital EDs to triage patients and reduction of adverse drug-to-drug interactions and needless duplicative tests. Also, with interoperable healthcare data on the national agenda, one would think that bringing a very large and important sector into the digital fold would be an obvious move.

So as I see it, making it possible for behavioral health and other medical providers can share data is simply a no-brainer.  But that can’t happen until these providers implement EMRs. And as previous experience has demonstrated, that’s not going to happen until some version of Meaningful Use incentives are available to them.

I imagine that the bill has faltered largely over the cost of implementing it. While I haven’t seen an estimate of what it would cost to expand eligibility to these new parties, I admit it’s likely to be very substantial. But right now the U.S. health system is bearing the cost of poorly coordinated care administered to about one-quarter of all U.S. adults over age 18. That’s got to be worse.

The Dawn of The Community EMR

Posted on May 29, 2015 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.

While many healthcare stakeholders would like to see clinical data shared freely, the models we have in place simply can’t get this done.

Take private HIEs, for example. Some of them have been quite successful at fostering data sharing between different parts of a health system, but the higher clinical functions aren’t integrated — just the data.

Another dead end comes when a health system uses a single EMR across its entire line of properties. That may integrate clinical workflow to some degree, but far too often, the different instances of the EMR can’t share data directly.

If healthcare is to transform itself, a new platform will be necessary which can be both the data-sharing and clinical tool needed for every healthcare player in a community. Consider the vision laid out by Forbes contributor Dave Chase:

Just as the previous wars impacted which countries would lead the world in prosperity, the “war” we are in will dictate the communities that get the lion’s share of the jobs (and thus prosperity). Smart economic development directors and mayors will stake their claim to be the place where healthcare gets reinvented.

In Chase’s column, he notes that companies like IBM have begun to base their decisions about where to locate new technology centers partly on how efficiently, effectively and affordably care can be delivered in that community. For example, the tech giant recently decided to locate 4,000 new jobs in Dubuque, Iowa after concluding that the region offered the best value for their healthcare dollar.

To compete with the Dubuques of the world, Chase says, communities will need to pool their existing healthcare spending — ideally $1B or more — and use it to transform how their entire region delivers care.

While Chase doesn’t mention this, one element which will be critical in building smart healthcare communities is an EMR that works as both a workflow and care coordination tool AND a platform for sharing data. I can’t imagine how entire communities can rebuild their care without sharing a single tool like this.

A few years ago I wrote about how the next generation of  EMRs would probably be architected as a platform with a stack of apps built over it that suit individual organizations. The idea doesn’t seem to have gained a lot of traction in the U.S. since 2012, but the approach is very much alive outside the country, with vendors like Australia’s Ocean Informatics selling this type of technology to government entities around the world. And maybe it can bring cities and regions together too.

For the short term, getting a community of providers to go all in on such an architecture doesn’t seem too likely. Instead, they’ll cling to ACO models which offer at least an illusion of independence. But when communities that offer good healthcare value start to steal their patients and corporate customers, they may think again.

EMRs Should Include Telemedicine Capabilities

Posted on May 22, 2015 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 volume of telemedicine visits is growing at a staggering pace, and they seem to have nowhere to go but up. In fact, a study released by Deloitte last August predicted that there would be 75 million virtual visits in 2014 and that there was room for 300 million visits a year going forward.

These telemedicine visits are generating a flood of medical data, some in familiar text formats and some in voice and video form. But since the entire encounter takes place outside of any EMR environment, huge volumes of such data are being left on the table.

Given the growing importance of telemedicine, the time has come for telemedicine providers to begin integrating virtual visit results into EMRs.  This might involve adopting specialized EMRs designed to capture video and voice, or EMR vendors might go with the times and develop ways of categorizing and integrating the full spectrum of telemedical contacts.

And as virtual visit data becomes increasingly important, providers and health plans will begin to demand that they get copies of telemedical encounter data.  It may not be clear yet how a provider or payer can effectively leverage video or voice content, which they’ve never had to do before, but if enough care is taking place in virtual environments they’ll have to figure out how to do so.

Ultimately, both enterprise and ambulatory EMRs will include technology allowing providers to search video, voice and text records from virtual consults.  These newest-gen EMRs may include software which can identify critical words spoken during a telemedical visit, such as “pain,” or “chest” which could be correlated with specific conditions.

It may be years before data gathered during virtual visits will stand on equal footing with traditional text-based EMR data and digital laboratory results.  As things stand today, telemedicine consults are used as a cheaper form of urgent care, and like an urgent care visit, the results are not usually considered a critical part of the patient’s long-term history.

But the more time patients spend getting their treatment from digital doctors on a screen, the more important the mass of medical data generated becomes. Now is the time to develop data structures and tools allowing clinicians and facilities to mine virtual visit data.  We’re entering a new era of medicine, one in which patients get better even when they can’t make it to a doctor’s office, so it’s critical that we develop the tools to learn from such encounters.

Meaningful Use Stage 3 Success Could Rely On Vendors

Posted on May 20, 2015 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 I was reading a report on the Health IT Policy Committee’s review of pending Meaningful Use Stage 3 rules — which would ordinarily be as about as exciting as watching rocks erode — when something leapt out at me which I wanted to share with you, dear readers.

The overview, brought to us courtesy of Medical Practice Insider, noted that proposed plans for the Stage 3 rule would allow providers to attest in 2017, though attesting wouldn’t be mandatory until 2018. What this means, editor Frank Irving notes, is that it would be up to EMR vendors to be ready for providers wishing to attest a year early.

The folks overseeing this discussion, the Advanced Health Models and Meaningful Use Workgroup, seem (wisely) to have had their doubts that vendors could be relied upon to meet the 2017 deadline. At the session, workgroup members proposed a couple of alternative ways of addressing this timeline. One was to make the 2017 deadline go away, requiring instead that EMRs have full 2015 certification by 2018. Another was to allow optional attestation in 2017, but if need be, with 2014 EMR certification.

I don’t know about you, but this whole thing makes me nervous. By “whole thing,” I mean adjusting the rules to deal with the likely resistance vendors will exhibit to keeping their roadmap in synch with federal requirements.

After all, consider the history of EMR vendors’ relationship with providers. As we’ve noted, HHS has paid out about $30B in Meaningful Use incentives under HITECH without insisting that vendors provide interoperability. And what have EMR vendors done?  They’ve avoided developing shared standards for interoperability with an alacrity which amazes the eye.

In fact, some EMR vendors — including top contender Epic Systems — have been slapping providers with fees for data sharing (even if they’ve kind of dropped them for now), at prices which could leave them millions in the hole. If that isn’t dead opposite to what those in public policy hope to see happen, I don’t know what is.

Bottom line, if the good people overseeing Meaningful Use want to see Stage 3 accomplish good things, they’ll need to see to it that the new rules give regulators some leverage when it comes to controlling vendors.

As the whole sad interoperability saga has demonstrated, vendors will not take actions that advance health IT on their own. Unlike in other IT markets, where interoperability and meeting regulatory deadlines have been the signs of a winner, EMR vendors actually have strong incentives to ignore providers’ business imperatives.

With any luck, however, between tougher rules on Stage 3 and public pressure to achieve interoperability, EMR vendors will do the right thing.  They’ve certainly had long enough.

Customizable EMRs Are Long Overdue

Posted on May 5, 2015 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.

EMRs can be customized to some extent today, but not that much. Providers can create interfaces between their EMR and other platforms, such as PACS or laboratory information systems, but you can’t really take the guts of the thing apart. The reality is that the EMR vendor’s configuration shapes how providers do business, not the other way around.

This has been the state of affairs for so long that you don’t hear too much complaining about it, but health IT execs should really be raising a ruckus. While some hospitals might prefer to have all of their EMR’s major functions locked down before it gets integrated with other systems, others would surely prefer to build out their own EMR from widgetized components on a generic platform.

Actually, a friend recently introduced me to a company which is taking just this approach. Ocean Informatics, which has built an eHealth base on the openEHR platform, offers end users the chance to build not only an EMR application, but also use clinical modules including infection control, care support, decision support and advanced care management, and a mobile platform. It also offers compatible knowledge-based management modules, including clinical modeling tools and a clinical modeling manager.

It’s telling that the New South Wales, Australia-based open source vendor sells directly to governments, including Brazil, Norway and Slovenia. True, U.S. government is obviously responsible for VistA, the VA’s universally beloved open source EMR, but the Department of Defense is currently in the process of picking between Epic and Cerner to implement its $11B EMR update. Even VistA’s backers have thrown it under the bus, in other words.

Given the long-established propensity of commercial vendors to sell a hard-welded product, it seems unlikely that they’re going to switch to a modular design anytime soon.  Epic and Cerner largely sell completely-built cars with a few expensive options. Open source offers a chassis, doors, wheels, a custom interior you can style with alligator skin if you’d like, and plenty of free options, at a price you more or less choose. But it would apparently be too sensible to expect EMR vendors to provide the flexible, affordable option.

That being said, as health systems are increasingly forced to be all things to all people — managers of population health, risk-bearing ACOs, trackers of mobile health data, providers of virtual medicine and more — they’ll be forced to throw their weight behind a more flexible architecture. Buying an EMR “out of the box” simply won’t make sense.

When commercial vendors finally concede to the inevitable and turn out modular eHealth data tools, providers will finally be in a position to handle their new roles efficiently. It’s about time Epic and Cerner vendors got it done!

Epic Belatedly Accepts Reality And Drops Interoperability Fees

Posted on April 21, 2015 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.

Unbeknownst to me, and perhaps some of you as well, Epic has been charging customers data usage fees for quite some time.  The EMR giant has been quietly dunning users 20 cents for each clinical message sent to a health information exchange and $2.35 for inbound messages from non-Epic users, fees which could surely mount up into the millions if across a substantial health system.  (The messages were delivered through an EMR module known as Care Everywhere.)

And now, Epic chose #HIMSS15 to announce grandly that it was no longer charging users any fees to share clinical data with organizations that don’t use its technology, at least until 2020, according to CEO Judy Faulkner.  In doing so, it has glossed over the fact that these questionable charges existed in the first place, apparently with some success. For an organization which has historically ducked the press routinely, Epic seems to have its eye on the PR ball.

To me, this announcement is troubling in several ways, including the following:

  • Charging fees of this kind smacks of a shakedown.  If a hospital or health system buys Epic, they can’t exactly back out of their hundreds-of-millions-of-dollars investment to ensure they can share data with outside organizations.
  • Forcing providers to pay fees to share data with non-Epic customers penalizes the customers for interoperability problems for which Epic itself is responsible. It may be legal but it sure ain’t kosher.
  • In a world where even existing Epic customers can’t share freely with other Epic customers, the vendor ought to be reinvesting these interoperability fees in making that happen. I see no signs that this is happening.
  • If Epic consciously makes it costly for health systems to share data, it can impact patient care both within and outside, arguably raising costs and increasing the odds of care mistakes. Doing so consciously seems less than ethical. After all, Epic has a 15% to 20% market share in both the hospital and ambulatory enterprise EMR sector, and any move it makes affects millions of patients.

But Epic’s leadership is unrepentant. In fact, it seems that Epic feels it’s being tremendously generous in letting the fees go.  Here’s Eric Helsher, Epic’s vice president of client success, as told to Becker’s Hospital Review: “We felt the fee was small and, in our opinion, fair and one of the least expensive…but it was confusing to our customers.”

Mr. Helsher, I submit that your customers understood the fees just fine, but balked at paying them — and for good reason. At this point in the history of clinical data networking, pay-as-you-go models make no sense, as they impose a large fluctuating expense on organizations already struggling to manage development and implementation costs.

But those of us, like myself, who stand amazed at the degree to which Epic blithely powers through criticism, may see the giant challenged someday. Members of Congress are beginning to “get it” about interoperability, and Epic is in their sights.

Adverse Event Reporting and EHRs: The MEDTECH Act’s Effects

Posted on December 18, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Medical systems generate adverse event (AE) reports to improve service delivery and public safety.

As I described in my first blog post on Adverse Events, these reports are both a record of what went wrong and a rich source for improving workflow, process and policy. They can nail responsibility not only for bad acts, but also bad actors and can help distinguish between the two. The FDA gathers AE reports to look for important health related patterns, and if needed to trigger recalls, modifications and public alerts.

EHRs generate AEs, but the FDA doesn’t require reporting them. Reporting is only for medical devices defined by the FDA and EHRs aren’t. However, users sometimes report EHR related AEs. Now, there’s proposed legislation that would preclude EHRs as medical devices and stop any consideration of EHR reports.

MEDTECH Act’s Impact

EHRs are benign software systems that need minimal oversight. At least that’s what MEDTECH Act’s congressional sponsors, Senators Orrin Hatch (R- Utah) and Michael Bennett (D- Colorado) think. If they have their way – and much of the EHR industry hopes so – the FDA can forget regulating EHRs and tracking any EHR related AEs.

EHRs and Adverse Events

Currently, if you ask MAUD, the FDA’s device, adverse event tracking system about EHRs, you don’t get much, as you might expect. Up to October, MAUD has 320,000 AEs. Of these about 30 mention an EHR in passing. (There may be many more, but you can’t search for phrases such as “electronic health,” etc.) While the FDA hasn’t defined EHRs as a device, vendors are afraid it may. Their fear is based on this part of the FDA’s device definition standard:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

…[I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…

I think this section clearly covers EHRs. They are intended for diagnostic, cure, mitigation, etc., of disease. Consistent public policy in general and a regard for protecting the public’s health, I think, augers for mandatory reporting of EHR caused AEs.

Why then aren’t EHRs devices that require AE reporting? In a word, politics. The FDA’s been under pressure from vendors who contend their products aren’t devices just software. They also don’t want their products subject to being criticized for failures, especially in instances where they have no control over the process. That may be understandable from a corporate point of view, but there are several reasons for rejecting that point of view. Consider what the FDA currently defines as a medical device.

Other Devices. The FDA captures AE reports on an incredible number of devices. A few examples:

  • Blood pressure computers
  • Crutches
  • Drug dose calculators
  • Ice bags
  • Lab gear – practically all
  • Robotic telemedicine devices, and many, many more.

ECRI on EHR Adverse Events

The respected patient safety NGO, the ECRI Institute, puts the issue squarely. Each year, it publishes its Top Ten Health Technology Hazards. Number one is inadequate alarm configuration policies and practices. Number two: “Incorrect or missing data in electronic health records and other health IT systems.” Its report says:

Many care decisions today are based on data in an electronic health record (EHR) or other IT-based system. When functioning well, these systems provide the information clinicians need for making appropriate treatment decisions. When faults or errors exist, however, incomplete, inaccurate, or out-of-date information can end up in a patient’s record, potentially leading to incorrect treatment decisions and patient harm. What makes this problem so troubling is that the integrity of the data in health IT (HIT) systems can be compromised in a number of ways, and once errors are introduced, they can be difficult to spot and correct. Examples of data integrity failures include the following:

  • Appearance of one patient’s data in another patient’s record (i.e., a patient/data mismatch)
  • Missing data or delayed data delivery (e.g., because of network limitations, configuration errors, or data entry delays)
  • Clock synchronization errors between different medical devices and systems
  • Default values being used by mistake, or fields being prepopulated with erroneous data
  • Inconsistencies in patient information when both paper and electronic records are used
  • Outdated information being copied and pasted into a new report Programs for reporting and reviewing HIT-related problems can help organizations identify and rectify breakdowns and failures.

ECRI spells out why AE reporting is so important for EHRs:

…[S]uch programs face some unique challenges. Chief among these is that the frontline caregivers and system users who report an event—as well as the staff who typically review the reports—may not understand the role that an HIT system played in an event…

The MEDTECH Act’s Effects

The move to curtail the FDA’s EHR jurisdiction is heating up. Senators Hatch and Bennett’s proposed act exempts EHRs from FDA jurisdiction by defining EHRs as passive data repositories.

Most industry chatter about the act has been its exempting EHRs and others from the ACA’s medical device tax. However, by removing FDA’s jurisdiction, it would also exempt EHRs from AE reports. Repealing a tax is always popular. Preventing AE reports may make vendors happy, but clinicians, patients and the public may not be as sanguine.

The act’s first two sections declare that any software whose main purpose is administrative or financial won’t come under device reporting.

Subsection (c) is the heart of the act, which exempts:

Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records,

Subsection (d) says that software that conveys lab or other test results are exempt.

Subsection (e) exempts any software that makes recommendations for patient care.

There are several problems with this language. The first is that while it goes to lengths to say what is not a device, it is silent about what is. Where is the line drawn? If an EHR includes workflow, as all do, is it exempt because it also has a chart function? The bill doesn’t say

Subsection (d) on lab gear is also distressing. Currently, most lab gear are FDA devices. Now, if your blood chemistry report is fouled by the lab’s equipment ends up harming you, it’s reportable. Under MEDTECH, it may not be.

Then there’s the question of who’s going to decide what’s in and what’s out? Is it the FDA or ONC, or both? Who knows Most important, the bill’s negative approach fails to account for those AEs, as ECRI puts it when: “Default values being used by mistake, or fields being prepopulated with erroneous data.”

Contradictory Terms

The act has a fascinating proviso in subsection (c):

…[P]rovided that software designed for use in maintaining such patient records is validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.

This language refers to information that device manufacturers file with HHS prior to marketing. Oddly, it implies that EHRs are medical devices under the FDA’s strictest purview, though the rest of the act says they are not. Go figure.

What’s It Mean?

The loud applause for the MEDTECH act coming from the EHR industry, is due to its letting vendors off the medical device hook. I think the industry should be careful about what it’s wishing for. Without effective reporting, adverse events will still occur, but without corrective action. In that case, everything will seem to go swimmingly. Vendors will be happy. Congress can claim to being responsive. All will be well.

However, this legislative penny in the fuse box will prove that keeping the lights on, regardless of consequences, isn’t the best policy. When something goes terribly wrong, but isn’t reported then, patients will pay a heavy price. Don’t be surprised when some member of Congress demands to know why the FDA didn’t catch it.

Microsoft Joins Battle for Wearables Market

Posted on November 4, 2014 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.

Following the lead of several other companies big and small, Microsoft has jumped into the wearables healthcare market with a watch, a fitness tracker and a cloud-based platform that condenses and shares data.

It’s little wonder. After a few years of uncertainty, it seems pretty clear that the wearables market is taking off like a rocket. In fact, 21% of US consumers own such a device, according to research by PricewaterhouseCoopers. That’s slightly higher that the number of consumers who bought tablets during the first two years after they launched, PwC reports. Not only Microsoft, but Apple and Samsung, as well as smaller players with a high profile — such as Fitbit — are poised to take the sector by storm.

Microsoft’s new entry is called Microsoft Health, a platform letting users store health and fitness data. The date in question is collected by a Microsoft Health app, available on Android, iOS and Windows Phone. The platform also gathers data generated from the Microsoft Band, a smart and designed to work with Microsoft’s new platform.

The idea behind pulling all of this data into a single platform is to integrate data from different devices and services in a smart way that allows consumers to generate insights into their health. The next step for Microsoft Health, execs say, is to connect all of that data in the platform to the tech giant’s HealthVault, a Web-based PHR, making it easier for people to share data with their healthcare providers.

Other tech giants are making their own wearables plays, of course. Google, for example, has released Google Fit, a fitness-based app designed to help users track physical activity. Google’s approach is  Android smart phones, relying on sensors built into the smart phones to detect if the user is walking, running or biking. Users can also connect to devices and apps like Noom Coach and Withings.

Apple, for its part, has launched HealthKit, its competing platform for collecting data from various health and fitness apps.  The data can then be accessed easily by Apple users through the company’s Health app (which comes installed on the iPhone 6.) HealthKit is designed to send data directly to hospital and doctor charts as well. It also plans to launch a smart watch early next year.

While there’s little doubt consumers are interested in the wearables themselves, it’s still not clear how enthusiastic they are about pulling all of their activity onto a single platform. Providers might be more excited about taming this gusher of data, which has proved pretty intimidating to doctors already overwhelmed with standard EMR information, but it remains to be seen whether they’ll find fitness information to be helpful.

All told, it looks like there will be a rollicking battle for the hearts and minds of wearables consumers, as well as the loyalty of providers.  As for me, I think it will be a year or two, at minimum, before we get a real sense of what consumers and providers really want from these devices.

The Other Talk: EHRs and Advance Medical Directives

Posted on September 11, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

The Other Talk: EHRs and Advance Medical Directives

Most of us who have adult children can remember that awkward talk we had about life’s origins. We thought, whew, that’s done. Alas, there’s yet another talk. This time it’s with those adult children and it’s about you.

This one’s covered in Tim Prosch’s and AARP’s book, The Other Talk. The talk, or more accurately the process is how you want to spend the rest of your life.

The Other Talk

It’s about your money, where and how you’ll live and your medical preferences. It’s just as hard, if not harder, than the old talk because:

  • It’s hard to admit that you won’t be around forever and your independence may start to ebb away.
  • You don’t want to put your kids on the spot with difficult decisions.
  • Your children may be parents coping with their own problems. You don’t want to add to their burdens.
  • You’ve been a source of strength, often financial as well as emotional. That’s hard to give up.

Prosch and AARP want to make it easier on everyone to deal with these issues.

He covers many topics, but for those of us who live in the EHR world one is of significant importance: Medical directives.

Prosch explains directives and simply says you should give them to your doctor. Easier said, etc. Today, that means not only your PCP, but also making sure that hospitalists etc., know what you want. While the Meaningful Use program helps a bit. It’s still going to take some doing.

Medical Directives and EHRs

EHR MU1 recognizes directives’ importance requiring that they be accounted for:

More than 50% of all unique patients 65 years old or older admitted to the eligible hospital’s or CAH’s inpatient department have an indication of an advance directive status recorded.

This means that the EHR has to have the directives. However, MU 1 only goes halfway to what’s needed. It’s what the EHR does with directives that’s unsaid.

If the EHR treats a directive as a miscellaneous document, odds are it won’t be known, let alone followed when needed. To be used effectively, an EHR needs a specific place for directives and they should be readily available. For example, PracticeFusion recently added an advance directives function. That’s not always the case.

Practice Fusion: Advanced Medical Directives

Googling for Directives

To see how about twenty popular EHRs treat directives, I did a Google site search, on the term directive. I got hits for a directives function only from four EHRs:

  • Athenahealthcare
  • Cerner
  • Meditech
  • PracticeFusion

All the others, Allscripts, Amazing Charts, eClinicalWorks, eMDs, McKesson, etc., were no shows. Some listed the MU1 requirement, but didn’t show any particular implementation.

Directives: More Honored in the Breech

This quick Google search shows that the EHR industry, with a few exceptions, doesn’t treat directives with the care they deserve. It should also serve as a personal warning.

If you already have directives or do have that talk with your family, you’ll need to give the directives to your PCP. However, you should also give your family copies and ask them to go over them with your caregivers.

Some day, EHRs may handle medical directives with care, but that day is still far off. Until then, a bit of old school is advisable.