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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.

Adverse Event Reporting: What Is It?

Posted on December 3, 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.

Eric Duncan’s Ebola death in Dallas was, to say the least, an adverse event (AE). Famously now, when he had a high fever, pronounced pain, etc., he went to Texas Health’s Presbyterian Hospital’s ER, and was sent home with antibiotics. Three days later much worse, he came back by ambulance.

In the aftermath of Duncan’s death, the hospital’s EHR, EPIC, came in for blame, though it was later cleared. Many questions have come from Duncan’s death including how our medical system handles such problems. Articles often use the term adverse event, but rarely mention reporting. I think it’s important to take a direct look at our adverse event reporting systems and where EHR and AEs are headed. This blog post looks at AE systems. The next will look at where EHRs fit in.

The FDA: Ground Zero for Adverse Event Reports

HHS’ Food and Drug Administration has prime, but not exclusive, jurisdiction over adverse reports breaking them into three classes:

  • Medicines
  • Medical Devices, and
  • Vaccines.

Four FDA systems cover these classes:

  • FAERS. This is FDA’s system for drug related adverse reports. It collects information for FDA’s post marketing for drug and biologic product surveillance. For example, if there’s a problem with Prozac, it’s reported here.
  • MAUDE. The Manufacturer and User Facility Device Experience reporting system. If an X-Ray machine malfunctions or lab equipment operates defectively, this is where the report goes.
  • VAERS. Vaccine adverse reports are collected here.
  • MEDSUN. This is voluntary, device reporting system gathers more detailed information than MAUD. It’s run by as a collaboration of the FDA and several hundred hospitals, clinics, etc. (Disclosure: My wife was MAUD project system developer.) MEDSUN captures details and incidents, such as close calls or events that may have had a potential for harm, but did not cause any. MEDSUN has two subsystems, HeartNet, which is for electrophysiology labs and KidNet for neonatal and pediatric ICUs.
DSC04388

MEDSUN Reporting Poster

State Adverse Event Reporting Systems

Several states require Adverse Event reporting in addition to FDA reports. Twenty-seven states and DC require Adverse Event reports, with varying coverage and reporting requirements. Some states, such as Pennsylvania, have an extensive, public system for reporting and analysis.

Patient Safety Organizations

Added to federal and state organizations are many patient safety organizations (PSOs) with an Adverse Event interest. Some are regional or state groups. Others, are national non profits, such as the ECR Institute.

The Safety Reporting Paradox

If you delve into an Adverse Event reporting systems, you’ll quickly see some institutions are more present than others. That doesn’t necessarily mean they are prone to bad events. In fact, these may be the most safety conscious who report more of their events than others. Moreover, high reporters often have policies that encourage AE reporting to find systemic problems without punitive consequences.

Many safety prevention systems work this way. Those in charge recognize it’s important to get all the facts out. They realize adopting a punitive approach drives behavior underground.

For example, the FAA has learned this the hard way. Recently on vacation, I met two air traffic controllers who contrasted the last Bush administration’s approach to now. Under Bush’s FAA errors were subject to public shaming. The result was that many systemic problems were hidden. Now, the FAA encourages reporting and separates individual behavior. The result is that incidents are more reported and more analyzed. If individual behavior is culpable, it’s addressed as needed.

In the next part, I’ll look at how EHRs fit into the current system and the congressional efforts to exempt them from reporting AEs, a move that I think is akin to putting pennies in a fuse box.

FDA’s Social Media Guidance Insights

Posted on July 23, 2014 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.

I had a chance to watch parts of a Google+ hangout discussing the latest FDA social media guidance with David Harlow from Health Blawg. I’ve had a chance to work on a number of things with David and he’s a really smart guy that’s on top of a lot of the regulations that affect healthcare. I guess that’s a feature of being a healthcare lawyer. For those who missed it, you can check out the full video interview with David below:

For those who prefer the cliff notes version, David published some bullet points on his blog that do a great job summarizing the main points and key takeaways:

  • The draft guidance makes use of Twitter and platforms like Google Ads extremely unattractive, because the vast majority of the “real estate” must be given over to brand and generic names, indications for use, benefits, risks, and a link to fuller information about risks.
  • The FDA addressed itself to short-form communication without considering the way in which it is used most effectively – not as a canvas for ads, but as a forum for conversation.
  • Unbranded tweetchats, Facebook pages, and the like were OK before the draft guidance was issued, and they still are.
  • The correction of misinformation guidance lowers the regulatory bar for corrections (vs. marketing messages that must meet higher standards and may be subject to pre-review).
  • The misinformation guidance does not require a drug or device manufacturer to address all misinformation online about its products. Corrections must be focused responses to what others put out there on line, and should link to fuller information where appropriate, but corrections should not include or link to promotional material.
  • The misinformation guidance delineates an area of opportunity for drug and device manufacturers.

You can read more on his blog post including someone getting in trouble for liking a patient’s status. Think about that for a minute. Is it any wonder that pharma’s been really careful with social media?

ONC’s Authority to Regulate Health IT

Posted on July 3, 2014 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.

New National Coordinator for Health IT, Karen DeSalvo, is facing a really interesting time for ONC. The meaningful use money is close to running out and so DeSalvo has to figure out how to assure the future of the ONC organization. A part of me wonders if Farzad saw this stage of the organization coming and got out while the getting was good. Regardless, ONC has always had a challenge getting funding for its health IT efforts and with meaningful use funding close to the end it’s going to be an even bigger challenge.

I think as part of this future one option would be for ONC to become the safety and risk based regulatory body for health IT. Although, this idea has been questioned by the House Energy and Commerce Committee in a letter embedded below.

I don’t want to dive deep into the politics and regulations around this since it’s not my area of expertise. Instead, I want to discuss at a high level ONC’s future and the balance between ONC and the FDA. I’ve written about the FDA regulation of EHR before. I don’t see it happening. I don’t think it will happen and I don’t think they have the skills to make it happen.

On the other hand, should ONC start regulating it? I don’t think they have the skills or expertise either to do it effectively. Not only do they not have the funding (and that’s unlikely to change), but I don’t think they have the people who can accomplish this task. Plus, I don’t think they should regulate EHR.

I do wish that ONC would go all in on dealing with interoperability of health data. If they did this, then ONC would be an important part of healthcare’s future.

What do you think of ONC and its future? What should they be working on? What could they do to really have an impact for good on the future of health IT in the US?

What if the FDA Started Regulating EHR?

Posted on March 20, 2014 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.

In the world of mobile health, we’ve often talked about what will happen if the FDA starts to regulate the various mobile health apps out there. In fact, the FDA has come out with some pretty detailed guidelines on what mobile health applications and devices need FDA clearance. To date, the FDA has stayed away from any regulation of EHR software.

On my ride to the airport after the Dell Healthcare Think Tank event, we had an interesting and engaging conversation about the FDA when it comes to EHR software. Some of the discussion was around whether the FDA would start regulating EHR software.

Shahid Shah suggested that it was extremely unlikely that the FDA would touch EHR software at least until meaningful use was complete and the current President was out of office. He rightfully argues that this administration has hung their hat on EHR and the FDA wasn’t going to step in and stop that program. Plus, Shahid suggested that ONC wouldn’t let the FDA do it either. Janet Marchibroda from the Bipartisan Policy Center was hopeful that Shahid was right, but wasn’t as confident of this analysis.

After hearing them discuss this, I asked them the question:

What would happen to the EHR Market if the FDA started regulating EHR?

Shahid quickly responded that the majority of EHR vendors would go out of business and only a small handful of companies would go through the FDA clearance process. Then, he suggested that this is exactly why the FDA won’t regulate EHR software. FDA regulation of EHR would wipe out the industry.

This is a really interesting question and discussion. The reality is that there are a lot of similarities between EHR software and medical devices. One could make a really good case for why the FDA should regulate it like medical devices. One could make a case for the benefit of some rigor in the development of EHR software. However, there’s no appetite for such a change. In fact, the only people I’ve seen calling for it are those who think that EHR is unusable and potentially harmful to patients. I’m not sure FDA regulation will make them more usable though.

Now, juxtaposition the above conversation with this post by William Hyman titled “A Medical Device Recall of an EHR-like Product” In this case, the FDA announced McKesson’s voluntary recall of it’s Anesthesia Care system. This software was tightly integrated with other FDA regulated medical devices. I wonder what this means for other EHR software that is starting to integrate with a plethora of FDA cleared medical devices and other non FDA cleared medical devices.

I’m personally with Shahid in that I don’t think the FDA is going to touch EHR software with a long pole. At least, not until after meaningful use. After meaningful use, I guess we’ll see what they decide to do.

23andMe Saga Doesn’t Bode Well for EMR Genetics Integration

Posted on December 5, 2013 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

I wrote about the direct-to-consumer genetic testing company 23andMe back in mid-October, posing the idea that genetic information provided by the patient could only serve to enrich EMR data. I noted, “Genetic testing seems to be about empowering patients to take more proactive roles in managing their health today in an effort to prevent what might happen to their health in the future. It would make sense to share these test results with providers who can aid in that journey.”

Two readers chimed in. One noted that, “No [current] EMR can run genetic risk models or use genetic clinical decision support, [and ] [n]one of these fit into Meaningful Use, so it will be years until the EMR have the capability needed to use genomics.”

Another pointed out that, “the price point on 23andMe was all I was waiting for, and I have my gene sequence already. Yes, there are some risks, but that argument falls into the same category as any technology or innovation – it can be used for good or bad. The value this information brings far exceeds the downsides, and is now an essential part of the data feed to my personal healthcare.”

That last comment is especially interesting in light of the well-publicized tiff going on between 23andMe and the FDA. I won’t waste your time attempting to summarize the string of events that have led 23andMe to stop marketing its products, as well as a class action lawsuit and an official petition to overrule the FDA’s decision. Instead, I’ve compiled a few articles that detail the saga as it has unfolded.

Why Genetic Testing Could Endanger Your Health / ChicagoTribune.com

The FDA Drops an Anvil on 23andMe – Now What? / Stanford.edu

Founder of 23andMe speaks on FDA concerns / USAToday.com

Can 23andMe Survive the FDA? / TheVerge.com

Class Action Lawsuit Filed Against 23andMe / Forbes.com

23andMe Shuts down health-related genetics testing to work with FDA / Gigaom.com (Updated 12/6)

As far as the connection between genetic information gathered via commercial means by patients being incorporated into EMRs, it doesn’t look like it will happen easily anytime soon. It seems there are bigger debates brewing over the scope of the FDA’s regulatory power over companies like 23andMe, what the definition of a medical device should be, and the value consumers find in these services. Do they really lead to unnecessary medical tests and procedures? Let me know your thoughts on the 23andMe saga in the comments below. You can also join me this Friday at 12 ET for the weekly #HITsm tweet chat. We’ll be touching on the impact 23andMe’s big genetics data could have on healthcare, provided they’re allowed to stay in business.

Developing Safety Critical Healthcare Software

Posted on June 21, 2013 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.

The Healthcare IT Guy, Shahid Shah, has a great post up on his blog about writing safety critical software using an agile, risk-based approach. Here’s a portion of the blog post where Shahid really hits the nail on the head:

Much of that [every software being custom] changed in the 90’s and then upended even further in the early part of the 21st century; we should no longer weighed down by the baggage of the past.These days even our hardware is agile and extensible, real-time operating systems are plentiful, software platforms are malleable, mHealth is well established, and programming languages are sophisticated so we need to be open to reconsidering our development approaches, especially risk-based agile.

Why should we use “risk-based” agile? Because not every single line of code in software can or should be treated equally – some parts of our medical device software can kill people, many parts merely annoy people, but most other parts simply aren’t worth the same attention as the safety-critical components. When you treat every line of code the same (as is often true in a plan-driven approach) and you have a finite amount of resources and time you end up with lower quality software and less reliable medical devices. It’s not fair to blame the FDA for our own bad practices.

I’m always amazed by Shahid’s knowledge and ability to describe something in simple terms. I should know since I’m often on calls with Shahid since he’s my partner in Influential Networks and Physia.

The irony is that in the EHR and mHealth world you could argue that many have taken too much of a lean approach to building their applications while the medical device world treats every part of the software as a patient safety issue. Now if we could just bring the two together into a more reasonable balance of what’s important from the safety side and what’s not.

As far as I can tell, the FDA is planning to mostly stay out of regulating the general mHealth and EHR side of healthcare IT and will stick to the medical devices and mHealth devices that fit under the medical device term. I think this is generally a good thing for a number of reasons. Not the least of which is that the FDA doesn’t have the expertise needed to regulate EHR software. However, I wouldn’t mind a touch more patient safety concern from EHR vendors. Maybe the EHR Code of Conduct will help add a little more to this concern.

Of course, as Shahid points out, you don’t have to sacrifice agile software development to develop safety critical software. This is true in medical device development, EHR development, and even mHealth development.

Study: Drug Problems Most Common EMR Safety Event

Posted on December 13, 2012 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 the phrase “EMR problems” comes to mind, most of us get a  mental image of hardware flaws, software bugs or integration problems. But according to a new study, the majority of EMR-related patient care problems stem from issues in how people interact with their system, specifically in documenting and administering medication.

In recent research, the Pennsylvania Patient Safety Authority queried the state’s patient safety reporting database to identify EMR-related events. After sifting out events that didn’t truly appear to be EMR-related, analysts were left with 3,099 patient safety issue reports. The events were then classified by the harm score assigned by the reporter.

As it turns out, the great majority of events (89%) resulted in no harm to the patient. Ten percent of events were reported as “unsafe conditions” but also resulted in no harm to the patient.  Fifteen events actually resulted in temporary harm to the patient:

* Six cases of entering wrong medication data
* Three cases of administering the wrong medication
* Two cases of ignoring a documented allergy
* Two cases of failure to enter lab tests
* Two cases of failure to document

The only event that resulted in significant harm stemmed from failure to properly document an allergy, analysts said:

Patient with documented allergy to penicillin received ampicillin and went into shock, possible [sic] due to anaphylaxis. Allergy written on some order sheets and “soft” coded into Meditech but never linked to pharmacy drug dictionary.

All told, medication errors were the most commonly reported event (81 percent), largely wrong-drug, dose, time patient or route errors (50 percent) or omitted dose (10 percent).

It’s worthy of note that according to the researchers, the narrative reports of EMR-related reports dug up from the Pennsylvania database differed meaningfully from reports found in FDA database MAUDE and Australia’s Advanced Incident Management System, which have different reporting requirements.

It seems that there’s a lot more work to be done in exposing the types of patient safety errors that may be unique to EMRs, but this looks like a good start.

Wireless Health, HIPAA, and Patient Engagement – Around Healthcare Scene

Posted on September 30, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

EMR and HIPAA

Wireless Health Data Collection Innovations Getting Hot

Some of the newest health data innovations are wireless. From a chip that can test blood sugar levels to an ECG that connects to a cell phone through blue tooth. The possibilities are endless when it comes to wireless devices.

HIPAA Infographic

HIPAA violations happen frequently. Some are criminal, others civil. This infographic explains some of the most common reason for HIPAA violations, and the penalties associated with them. Last year, over 12,000 companies have either been investigated or had issues resolved concerning HIPAA violations. Definitely an interesting infographic to look over.

Hospital EMR and EHR

FCC Says Wireless Health Should Be “Routine” Within Five Years

An announcement from the FCC pushes for mHealth to be a standard practice in the medical world by 2017. Some doctors are hesitant to implement mobile devices, so this may be difficult for some to grasp. The FCC is working to make this easier, by doing things like working with the FDA to help with creating and introducing devices into the market.

Happy EMR Doctor

Patient Engagement: Who are the Real Targets?

While creators of health technology claim they are trying to reach patients most, what does that mean? Many people who would benefit from these types of technology are lower class, however, upper class people are probably more likely to embrace it. Should companies invest more time in discovering who target markets are?

Smart Phone Health Care

Traqs: One Tool to Rule Them All

Having trouble keeping track of all the health apps and devices that are being created? Traqs, a new device, does it for you. This innovation can track multiple devices and create graphs about activity on them. It makes it much easier to take control of your health and exercise devices.

EMR-EHR Safety Watchdog Unlikely To Emerge Soon

Posted on August 13, 2012 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.

Yesterday, we at HealthcareScene.com got a letter from the organization behind EHREvent.org, a patient safety organization allowing people to anonymously report EMR-related safety events, stating that the site was shutting down.  PDR Secure LLC gave little information on the closure, other than to say that it was relinquishing its PSO status.

Curious, John and I took a closer look at the matter. The only other organization which seemed to allow for reporting of EMR-related safety incidents, EHREventS.org (“S” capitalized for clarity), seems to have disappeared since it was first launched late last year.

So while Google searches aren’t perfect, it does appear that at the moment, there’s no official source to which providers, hospitals or other interested parties can report patient safety incidents related to problems with an EMR/EHR.

It’s worth noting that the FDA seems quite concerned about establishing EMR safety regulations. In fact, agency members have been in discussion for years on the topic, spurred by reports of HIT-related malfunctions. “Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist,” Dr. Jeffrey Shuren of the agency’s Center for Devices and Radiological Health told Congress in 2010.

But so far, the agency hasn’t issued any regs. My feeling is that FDA leaders are stalling (prompted in part, I’m guessing from indirect lobbying pressure) on getting such a system started, as it’s definitely going to irritate some very deep-pocketed HIT players out there.

As FierceEMR editor Maria Durben Hirsch noted in an excellent recent column, there’s more than one way the private sector could take up the role of EMR safety watchdog, such as:

*  Creating a one-stop site where users and others can report on their experiences with EMR systems, a step the AMA has apparently considered

*  Launching a new watchdog agency, run by HHS, which would oversee EMR registration, monitor for health IT-related mistakes and investigate adverse event reports.  According to Durben, Congress likes this idea — which was proposed by the Institute of Medicine — but that there’s been no action yet.

Bottom line, it seems that reporting on adverse EMR events is a very unpopular idea in many quarters, or at least a political hot potato.  I suspect someone, perhaps HHS or even the POTUS, is going to have to hammer EMR reporting into place if it’s going to happen anytime soon.