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Karen DeSalvo Remains as National Coordinator of ONC Along with New Position

Posted on October 31, 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 case you missed it, last week it was announced that Karen DeSalvo had been appointed Assistant Secretary of Health focused on Ebola by HHS Secretary Burwell. In that same announcement Jacob Reider also announced his departure from ONC.

While the news was true that DeSalvo was taking on a new role at HHS as Assistant Secretary of Health, ONC also published a blog post that DeSalvo would stay on as National Coordinator of Health IT as well:

Dr. DeSalvo will serve as Acting ASH while maintaining her leadership of ONC. Importantly, she will continue to work on high level policy issues at ONC, and ONC will follow the policy direction that she has set. She will remain the chair of the Health IT Policy Committee; she will continue to lead on the development and finalization of the Interoperability Roadmap; and she will remain involved in meaningful use policymaking. She will also continue to co-chair the HHS cross-departmental work on delivery system reform.

Lisa Lewis will provide day to day leadership at ONC. Lewis served as Acting Principal Deputy National Coordinator before Dr. DeSalvo joined ONC, so she has had experience with all parts of our work. She will lead our extremely talented and very strong team during Dr. DeSalvo’s deployment to the Office of the Assistant Secretary for Health.

But most importantly, the team that is ONC is far more than one or two leaders. The team of ONC is personified in each and every individual – all part of a steady ship and a strong and important part of HHS’ path toward delivery system reform and overall health improvement.

Seems like an awkward arrangement if you ask me. DeSalvo will be providing high level leadership on policy direction, but Lisa Lewis will handle the day to day leadership. That job description for DeSalvo sounds like something an Assistant Secretary of Health might do and Lisa Lewis’ job sounds like something the National Coordinator would do.

I’m sure there’s more to this story. Maybe moving DeSalvo to Assistant Secretary was a way for ONC to save money and keep DeSalvo on board working on healthcare IT. If ONC’s budget gets cut, then HHS still has a way to pay for DeSalvo. Maybe that’s why Lisa Lewis can’t be promoted to full National Coordinator. Then again, maybe it’s like I mentioned when we first heard the DeSalvo news, DeSalvo is more of a public health person than she is a healthcare IT person.

The fact that DeSalvo is remaining as National Coordinator is interesting. However, I just came back from CHIME (healthcare CIO conference) where DeSalvo was scheduled as one of the plenary session speakers. However, she didn’t show and so the whole session was cancelled. I guess you could make the case that she’s got Ebola to deal with right now, but it also illustrates how health IT will be playing second fiddle for her going forward. Likely says something about the future of ONC.

What Software Will Replace EHR?

Posted on April 15, 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’m usually a very grounded and practical person. I’m all about dealing with the practical realities that we all face. However, every once in a while I like to sit back and think about where we’re headed.

I’ve often said that I think we’re locked into the EHR systems we have now at least until after the current meaningful use cycle. I can’t imagine a new software system being introduced in the next couple years when every hospital and healthcare organization has to still comply with meaningful use. Many might argue that meaningful use beyond the current EHR incentive money might lock us in to our existing EHR software for many years after as well.

Personally, I think that a new software will replace the current crop of EHR at some point. This replacement will likely coincide with the time an organization is up for renewal of their current EHR. The renewal costs are usually so high that a young startup company could make a splash during renewal time. Add in a change of CIO and I think the opportunity is clear.

My guess is that the next generation of healthcare documentation software will be one that incorporates data from throughout the entire ecosystem of healthcare. I’m not bullish on many of the current crop of EHR software being able to make the shift from being document repositories and billing engines into something which does much more sophisticated data analysis. A few of them will be able to make the investment, but the legacy nature of software development will hold many of them back.

It’s worth noting that I’m not talking about the current crop of data that you can find outside of the healthcare system. I’m talking about software which taps into the next generation of data tracking which goes as far as “an IP address on every organ.” This type of granular healthcare data is going to change how we treat patients. The next generation healthcare information system will need to take all of this data and make it smart and actionable.

To facilitate this change, we could really use a change in our reimbursement system as well. ACOs are the start of what could be possible. What I think is most likely is that the current system will remain in place, but providers and organizations will be able to accept a different model of payment for the healthcare services they provide. While I fear that HHS might not be progressive enough to do such a change, I’m hopeful that by making it a separate initiative they might be able to make this a reality.

What do you think? What type of software, regulations and technology will replace our current crop of EHR? I don’t think the current crop of EHR has much to worry about for now. However, it’s an inevitable part of a market that it evolves.

Will Healthcare.gov Experience Prompt HHS to Delay ICD-10?

Posted on November 4, 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.

I don’t think it will be news to anyone reading this that HHS is getting hammered for their implementation of Healthcare.gov. Sebelius congressional testimony was brutal. Certainly the botched implementation of Healthcare.gov will have long lasting impacts on all future HHS IT projects.

While not purely an IT project, I wonder if the experience of Healthcare.gov will have an impact on the ICD-10 implementation. Will HHS be gun shy after the Healthcare.gov debacle that they’ll delay ICD-10 to avoid another one?

My gut reaction is that I don’t think this will happen, but it’s worthy of consideration.

On October 1, 2014, HHS’s IT isn’t ready to accept ICD-10, then you can read the headline already: “HHS Botches Another IT Project.” For those of us that work in healthcare IT, we know that ICD-10 has deep IT implications. Not the least of which will be CMS being ready to accept the ICD-10 codes. While you’d think this is a simple change, I assure you that it is not. Plus, if CMS isn’t ready for this, a lot of angry doctors and hospitals will emerge. It will be a major cash flow issue for them.

We still have almost a year for HHS to get this right. Plus, HHS has had years to plan for this change so they shouldn’t have any IT challenges. Although, if they do have IT challenges this extended time frame will damage them even more. The article will say they had plenty of time and they still couldn’t implement it properly.

With the comparison, there are also plenty of reasons why ICD-10 is very different than Healthcare.gov. In many ways, ICD-10 is a project implemented by companies outside of HHS as opposed to a project run by HHS. First, I think it’s unlikely that HHS won’t have their side ready for ICD-10. Second, their part of ICD-10 is very little compared to what has to be done by outside payers, hospitals, and doctors offices.

If ICD-10 has issues it will likely be seen as the payers or healthcare organizations not being ready as opposed to HHS. That’s not to say that HHS won’t have some damage if they force an ICD-10 mandate and people aren’t ready. They could have some collateral damage from it, but not the same as Healthcare.gov where the product is really their own product.

Plus, if ICD-10 goes bad, consumers/patients won’t know much difference. No patient cares if you code their visit in ICD-9 or ICD-10. They’ll still get the exact same care when they’re visiting the doctor. If ICD-10 goes bad, it will be doctors and hospitals that suffer. That’s a very different situation than Healthcare.gov which was to be used by millions of Americans.

I hope that HHS doesn’t delay ICD-10 based on their experience with Healthcare.gov. If HHS becomes gun shy about any project that IT touches, nothing will ever get done. That’s a terrible way for an organization to function.

MGMA Raises Meaningful Use Stage 2 Concerns

Posted on August 26, 2013 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.

Becoming another of several groups asking for Meaningful Use changes, the head of the Medical Group Management Association has written a letter to HHS outlining several concerns the group has with Meaningful Use Stage 2.

In the letter, which was addressed to HHS Secretary Kathleen Sebelius, MGMA President and CEO Susan Turney raised several issues regarding the ability of her members to step up to Stage 2. She argued that physicians have a “diminished opportunity” to achieve Stage 2 compliance, and that as a result it would be unfair to impose Medicare reimbursement sanctions on her members. Turney argues that HHS should institute an “indefinite moratorium” on practices that have successfully nailed Stage 1 Meaningful Use requirements.

Why should HHS give practices a break?  The reason, she says, is that vendors are proving slow to produce Stage 2-certified products, leaving medical practices in the lurch. At the time of writing, Turney said, there were only 75 products and 21 complete EMRs certified for Stage 2 criteria, a small fraction of the more than 2,200 products and nearly 1,400 complete EMRs certified under 2011 criteria for ambulatory eligible professionals.

With vendors largely not ready yet to help practices through Stage 2, practices are likely to have little time to work on software upgrades or expect timely vendor support, she notes. And worse, EPs who invested big in Stage 1-certified EMRs might need to “rip and replace” them for a new one certified to meet Stage 2 if they want to avoid Medicare reimbursement cutback deadline.

On top of all of this, she notes, many practices are having to wait in line for Stage 2 upgrades of their EMR product behind practices adopting  an EMR for the first time. The wait is lengthened, meanwhile, by vendors’ attempts to cope with ICD-10 support, whose Oct. 1, 2014 deadline falls right in the middle of preparations for Meaningful Use Stage 2.

Turney makes a lot of sense in her comments. The vendor market clearly isn’t going to be able to keep up with ICD-10, MU upgrades and new installation within the same time period. I don’t know if an indefinite moratorium on Medicare penalties is the right policy response, but it should certainly be given some thought.

After all, punishing doctors who drop out of Meaningful Use due to factors beyond their control isn’t going to help anyone, either.

CMS Shares Benefits Of Meaningful Use

Posted on July 23, 2013 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.

CMS has released new data which lays out some of the benefits of Meaningful Use since the inception of the program in 2011.  The data outlines various ways in which Meaningful Use requirements have played out statistically.

According to the statement, the following landmarks have been reached over the last few years:

• More than 190 million electronic prescriptions have been sent by doctors, physician’s assistants and other health care providers using EMRs.

• Health care professionals sent 4.6 million patients an electronic copy of their health information from their EMRs.

• More than 13 million reminders about appointments, required tests, or check-ups were sent to patients using EMRs.

• Providers have checked drug and medication interactions to ensure patient safety more than 40 million times through the use of EMRs.

• Providers shared more than 4.3 million care summaries with other providers when patients moved between care settings.

It’s clear from these stats that e-prescribing is on a serious roll — though it’s interesting to me that over the last few years I’ve only had my scripts e-prescribed a couple of times.  Clearly there’s a lot more work to do there despite the large number.

On the other hand, these factoids aren’t staggering given that they’re cumulative over a few years. For example, while it’s encouraging that providers have shared more than 4 million care summaries (Continuity of Care Documents, I assume), that’s still a tiny fraction of the volume that we’ll need to see to say we have anything like real interoperability.

I was actually surprised to see that the reminders issued about appointments, tests and check-ups stood at a relatively modest 13 million. Primary care practices, in particular, are under such pressure to make sure patients hit their marks that you’d think setting up such reminders would be a no-brainer. But apparently it’s not.

All told, the numbers cited by CMS definitely suggest progress, but not as big of a win as the agency might have preferred. Let’s see the numbers for patient data sharing up in the hundreds of millions and then I’ll really be impressed.

HHS Releases Health IT Safety Plan

Posted on July 3, 2013 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.

HHS has released a plan designed to strengthen health IT-related patient safety efforts, offering “specific and tangible” advice for stakeholders across the healthcare industry spectrum as to how they can participate.

The Health IT Patient Safety Action and Surveillance Plan builds on an earlier effort by the Institute of Medicine which examined how to make health IT-assisted care safer.  This Plan breaks down further how key health system players such as patients, providers, technology companies and healthcare safety oversight bodies can take appropriate steps to improve health IT safety.

The Plan also spells out the steps HHS believes it should take to make sure knowledge of best practices in health IT are leveraged to make a difference.  The following offers a few examples of what the agency expects to do:

Use Meaningful Use and the National Quality Strategy to advance health IT safety:  HHS plans to use knowledge of health IT safety risks and trends, and focus that knowledge on clinical areas where there’s already safety issues (such as surgical site infections). ONC, for its part, is going to establish a public-private mechanism for developing health IT-related patient safety measures and targets. And HHS also plans to incorporate these improvement priorities into the Meaningful Use program.

Incorporate safety into certification criteria for health IT products:  ONC expects to update its certification criteria for health IT products — including EMRs — to address safety concerns.  ONC  has already incorporated safety principles for software and design principles in its 2014 final rule, but just two such requirements  Expect more to come.

Support R&D of testing, user tools, and best practices related to health IT safety:   HHS and its federal partners are supporting R&D of evidence-based tools and interventions for health IT developers, implementers, clinical staff and PSOs.  This year, ONC will begin disseminating a new class of health IT safety tools designed to help health IT implementers and users assess patient safety and leverage the latest applied knowledge of health IT safety.

*  Incorporate health IT safety into education and training for healthcare pros:  Through its Workforce Development Program, ONC awarded grants to universities and community colleges to develop health IT programs. This effort will continue, but will add up-to-the-minute information on health IT-related safety to the schools’ programs.

*  Investigate and take corrective action addressing serious adverse events or hazards involving health IT:  HHS plans to work with private sector organizations which have the capacity to address such events or hazards, including The Joint Commission.

This is a meaty report, and I’ve barely skimmed the surface of what it has to say. I recommend you review it yourself. But if you’re looking for a quick takeaway, just know that HHS is entering a new era with its focus on health IT safety, and if the agency gets half of what it plans done, there are likely to be some serious ripple effects.

EMR Rollouts: Are They Ethical?

Posted on February 28, 2013 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.

Here’s something you should really see for yourself. Over at Dr. Wes’s blog, the good doctor has written a long and thoughtful post on whether rolling out EMRs to patients actually constitutes medical experimentation without patient consent.

I thought readers who don’t have time to read all of Dr. Wes’s carefully-structured argument might be interested in hearing a bit of what he has to say, as I believe his conclusions are important. Here’s some of his assertions:

*  EMR costs are ultimately passed along to patients, whether they like it or not. And with insurance premiums climbing as much as 20 percent in 2013, patients are already having serious trouble paying for care.

* With EMRs still not interoperable in most cases, the efficiencies we’d hoped for largely aren’t showing up yet.  In fact, EMRs are adding to inefficiencies as doctors struggle to add needless data to electronic charts.

* With health data breeches continuing and errors growing, EMRs may be part of the problem and not the solution.

So, he suggests that we take a pause and ask ourselves some tough questions:

Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

Dr. Wes, in summary, wonders whether it’s unethical to roll out EMRs en masse given the still-unanswered questions about their benefits, their safety and their efficiency. And I think he’s asked a question worth answering. How about you?

Sebelius’ ACA Highlights Need a Dash of HIT Benefits for Parents

Posted on January 3, 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.

As a mother of young children, I have the pleasure of trying to squeeze in routine, pediatric dental appointments during Christmas and summer breaks. This time around, I had the added pleasure of taking my daughter to a new dentist – one within the same group she’s been going to for all of two years, but at a different location. Though I had her dental records transferred from the previous office, I still had to fill out a plethora of new patient forms upon arrival at the new location. Needless to say, the smile I gave the receptionist as she handed me a sheaf of papers asking me for redundant information was somewhat thin.

I passed the time flipping through the pages of a recent Parents magazine, and imagine my surprise when I came across an interview with Secretary of Health and Human Services Kathleen Sebelius regarding the Affordable Care Act and its implications for women and families. I thought it was a good idea on the part of Parents editors to have Sebelius explain – succinctly and briefly – the highlights of the ACA, especially pertaining to preventive services and the supposed affordability of health insurance once health insurance exchanges get up and running in 2014.

Being that I had just wasted 15 minutes of time filling out duplicate paper forms, I felt that a sidebar on the benefits of healthcare IT might also help out harried mothers like myself. Bullet points would include:

* Do your mental health a favor and avoid filling out paper forms in waiting rooms while your children “entertain” others with their shenanigans/arguments. Do business only with “digital” docs – those who utilize electronic medical records, enable sign-in via the Web before you arrive at the office, and are willing to communicate via email. Those that offer telemedicine services (provided your insurance will cooperate) are an added bonus if your family lives somewhat off the beaten healthcare path.

* Healthcare will become more affordable once consumers start making an effort to patronize providers that have a reputation for high patient satisfaction and quality scores. Get engaged via websites like Healthgrades.com to start sifting through local MDs’ scores and reviews.

* Assuming you’re a connected parent – one that routinely uses a smartphone and/or tablet, ask your healthcare provider about apps specific to any wellness or illness issues your children may be experiencing. I certainly wouldn’t mind switching out my children’s Toca Boca screen time with educational health games and stories.

These were just a few of the items running through my mind when my daughter’s dental hygienist asked if she had x-rays last time around, adding that those hadn’t come over yet from the other office, and the process of looking them up was overly complicated.

As Seth Meyers says on SNL, “Really?!”

HealthCare.gov

Posted on December 26, 2012 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.

If you haven’t been to HealthCare.gov for a while, go and check it out. If you didn’t know better, you’d think that HealthCare.gov was built by a company and not the government. This is true all the way down to the HealthCare.gov Blog featured on the home page. I applaud Todd Park and the others at HHS who took a different approach to how a government website should look and feel. They even have a scrolling set of stories about patients and benefits. You’d think they have something to sell us.

Well, I guess they do have something to sell. They are definitely trying to sell us on ACA (aka Obamacare) and the benefits that come from Obamacare. Although, the tools that I found most interesting were the Insurance Options Wizard which walks you through all the options you have to getting insurance. Not to mention a whole set of tools to try and help people understand using insurance. Although, I’m pretty sure most of that’s not going to be read. So, hopefully it’s got a good dose of search engine optimization applied so that it will show up in search engines where it might get a chance at being read.

We’ve written about the “Comparing Care Providers” part of HealhCare.gov before. It’s pretty gutsy for a government organization to go there at all. Certainly they are taking a pretty high level approach to their “comparison” but we’ll see how much they dig into it going forward. Will those doctors that are part of an ACO that’s striving to be reimbursed on the quality of care be listed different than other doctors? It will be interesting if tools like these start to differentiate which patients go to which providers.

I do wish that the website did more to get patients involved in their healthcare. Here’s what I said in my “All I Want for Christmas…” post on EMR & HIPAA:

More Empowered and Trusted Patients – Imagine where the patient was a full participant in their healthcare. That includes being trusted and listened to by their doctor and a patient who thoughtfully considers and listens to their doctor. This is not a one sided issue. This is something that both patients and doctors can improve. There are as many belligerent patients as their are arrogant doctors. We need a good dose of humility, care and trust re infused into healthcare. I think they only way we’ll get there is for the lines of communication to open up on an unprecedented level.

Seems like HealthCare.gov is one place that could help reach this goal. I guess in some ways the physician comparison engine could work towards this. How cool would it be if they listed which of the physicians used EHR and which EHR that physician used? Reminds me of “Got EMR?” ad campaigns I first wrote about about 6 years ago.

EMR or Not, we’re quickly heading to a world where doctors are differentiated on the technical services they provide their patient. Doctors are starting to be judged by their medical website and the services they provide on that website. Do they accept online appointment requests? Do they accept online payments? Can the patient communicate electronically with the clinic? Can the patients receive their patient records electronically?

It will start with a handful of doctors and then start to spread. Plus, it will be accelerated if HealthCare.gov or some other website starts to highlight those doctors who offer these type of services and those that don’t.

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.