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New EHR Certification Rules Including Self-Declaration – MACRA Monday

Posted on September 25, 2017 I Written By

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

This post is part of the MACRA Monday series of blog posts where we dive into the details of the MACRA Quality Payment Program (QPP) and related topics.

Elise Sweeney Anthony and Steven Posnack recently announced on the ONC Health IT Blog two major changes to the EHR certification program. In some ways, it shows a maturity of the EHR certification program, but in other ways, it’s ONC kind of taking a more hands off approach to EHR certification.

Here are the two big changes they made:

  1. Approving more than 50% of test procedures to be self-declaration; and
  2. Exercising discretion for randomized surveillance of certified health IT products.

The first one is really fascinating since they’re making 30 out of the 55 certification criteria as “self-declaration only.” That basically means that EHR vendors will just have to claim they meet the requirements. The ONC-ACBs won’t be certifying those 30 test procedures. In many ways, it reminds me of the meaningful use self-attestation. Does that mean that ONC-ACBs will cut their costs in half? Don’t be holding your breath on that one.

Let’s just hope that most EHR vendors don’t self-certify the way eCW approached EHR certification. Although, the eCW EHR certification issues are the perfect example of why a company self certifying their EHR software or the ONC-ACB certifying the EHR software is just about the same. I haven’t seen which test procedures will be self-declared, but my guess is that it was the ones that the ONC-ACBs weren’t really doing much to test and certify anyway. Ideally, this will free up the ONC-ACBs to dive deeper into the 25 test procedures they’ll still complete so they can avoid another eCW like incident.

Some might wonder why we don’t just take the self-declared EHR certification tests altogether if there’s no one that’s going to be checking them. What those people miss is that the self-declaration still keeps the EHR vendors on the hook for properly implementing the EHR certification criteria. If it’s discovered that they claimed to be compliant but aren’t, then the government can go after the EHR vendor for false claims.

The second change has me a little more puzzled. I’m not sure why they would want to release ONC-ACBs from the requirement to randomly audit EHR certifications. Maybe they didn’t discover any issues during their random audits and so they didn’t see a need to continue them. Or maybe the ONC-ACBs said they were going to pull out as certifying bodies if the government didn’t lighten the EHR Certification load. This is all conjecture, but they could be some of the reasons why ONC decided to make this change. They did offer the following insight into their reasoning:

This exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition.

I wonder how many complaints the ONC-ACBs have gotten about the EHR software they’ve certified. Have they just been so overwhelmed with complaints that they need more time to deal with those complaints and so audits aren’t needed? I’d be surprised if this was the case. At this point I imagine most people with EHR certification issues will be calling the whistle blower attorneys, but I could be wrong.

All in all, I don’t think these EHR certification changes are a huge deal. It’s largely a maturing of the EHR certification program and does little to help the EHR certification burden on software vendors. Maybe the ONC-ACBs will charge a little less for their certification, but that’s always been a negligible cost compared to the development costs to become a certified EHR. I’m sure the ONC-ACBs are happy with these changes though.

What do you think of these changes? Any other impacts I haven’t described above that we should consider?

EHR Innovation & Regulation: Friends or Foes?

Posted on August 16, 2017 I Written By

The following is a guest blog post by Stephen Dart, Sr. Director of Product Management at AdvancedMD.

Healthcare insiders often point out how far behind the industry is in taking advantage of technology when compared to industries like retail or finance.

Technology providers get their share of blame for not designing it with a user in mind, a common argument heard in relation to the Electronic Health Record (EHR) ill-fitting place in the physician’s workflow. What is not talked about much is the role regulations play in shaping the technology and its use in healthcare.

Designing for compliance

Regulations are present in every industry and serve an important function of protecting individuals’ privacy and rights. Healthcare is highly regulated compared to many other industries due to the sensitive nature of Protected Health Information.  There is a good deal of additional regulations regarding programs such as MACRA, dedicated to monitoring provider performance and reporting it back to the government for reimbursement. As such, technology for providers must be designed to capture and report such data.

For vendors like AdvancedMD, one of the challenges is not in designing software to address the regulations, but rather in designing it under the ever-evolving guidelines and shifting deadlines. At times, well-meaning standards also fail to function as intended because they are not enforced end-to-end.

As an example, Meaningful Use Stage 2 required the EHR to meet a standard for interfacing with state immunization registries. For certification, technology providers had to produce a standard-format file and transmit it to the state immunization registry. However, every state had its own set of requirements and most states would not accept the format designated as the certification requirement but instead have their own additional or different requirements.

Consider lab results as another example. The EHR has to meet the engineering standard for using a LOINC code when receiving lab results to enable the physician to report metrics for regulatory attestation. Unfortunately, labs are not held to the same standard, and if the lab does not send results using the LOINC code, the physician cannot get credit when reporting or has to manually add a code for it to be considered for meeting the performance metric.

Naturally, there is cost incurred to design compliance features for vendors. At AdvancedMD, it has a significant impact on our research and development (R&D) budget. It also influences the other two R&D categories that have a direct impact on the end-user experience – keeping the technology on the cutting edge and innovation.

Integrating compliance into workflow

If regulations require physicians to report more data, vendors have a choice of designing compliance features to either ask the physician to input that information manually or to capture it automatically for reporting.

At AdvancedMD, a lot of effort goes into automating the regulatory requirements and integrating the necessary data collection naturally into providers’ existing workflow. If software identifies that the physician has just written an electronic prescription, there is no reason to ask him or her to go into a separate system and attest manually to having done so. This regulatory tracker can be natively built into the platform.

All roads lead to innovation

There is a lot of pressure on everyone in healthcare today and the industry is undergoing constant changes. Patients expect more as they pay more under high-deductible plans.  They increasingly rely on wearables to tell them how well they sleep and how many steps they need to take as part of a larger trend of taking command of their own health. Doctors and patients alike will benefit from this data being integrated into patient records.  If this patient-captured data can be merged into the patient chart, machine learning and analytics algorithms can in some cases predict what an independent practice needs to do next. This next step could be to streamline administrative processes for outreach messaging and improve care through electronic follow-up, leading to increased profitability and better care. Importantly, the EHR, practice management and all other technologies designed for providers need to liberate them to focus on patient care, not distract from it.

All these advanced features are the next frontier in healthcare and require vendors to dedicate a lot more effort and budget to innovation. While healthcare technology can’t be expected to catch up with an Apple or Facebook overnight with regard to user experience, there is much that can be done to close the gap. The industry as a whole will get there much faster when regulations and technology align to advance that goal.

Incremental regulatory steps in areas where standards can be controlled and enforced cradle-to-the-grave will benefit all parties. Vendors can plan their engineering budgets in advance and design fully functional compliance features. The industry will benefit from designing with the user in mind, furthering the role regulations play in shaping technology and its use in healthcare. Ultimately, regulations should allow providers to focus on care and to engage more meaningfully with their patients, thus optimizing the EHR’s role in the physician’s workflow.

Is ICSA Labs Getting Out of the EHR Certification Business?

Posted on April 18, 2017 I Written By

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

I got the following email that was received by ICSA customers:

Dear Valued Customer:

Your organization has received product testing and certification services as a customer of ICSA Labs, a division of MCI Communications Services, Inc., d/b/a Verizon Business Services (“ICSA Labs”).

I am writing to inform you that ICSA Labs will no longer be accepting new engagements for product testing and certification, or renewing expiring Statement(s) of Service. However, please be assured that we will continue to honor any existing, active Statements of Service that we may have with your organization, and to maintain any current certifications for the applicable term.

Thank you for your attention to this matter. If you have any questions, please contact icsalabsinfo@icsalabs.com.

Sincerely,

George Japak
ICSA Labs, Managing Director

Does this mean ICSA is withdrawing as an EHR Certifying body (ATCB)? I asked EHR certification expert, Jim Tate, which EHR certifying bodies remain if ICSA is pulling out and he said that right now Drummond, ICSA, InfoGard, and SLI are authorized to test and only Drummond, ICSA, and InfoGard are authorized to certify. You can find more details on the ONC website.

A part of me isn’t really surprised since the EHR certification business isn’t a great business. There are a limited number of clients and a limited amount of revenue available. Plus, under meaningful use, EHR certification became a commodity. That’s why CCHIT couldn’t survive. Seems like ICSA Labs is heading the same direction as CCHIT.

The bigger question I would ask is should EHR certification continue at all?

New EHR Incentive Program FAQs from CMS

Posted on November 10, 2015 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.

On October 6, the Centers for Medicare & Medicaid Services (CMS) released the final rule with comment for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. To keep you informed of changes to the programs and how to participate in 2015, CMS has also released three new FAQs providing clarification on how to attest to certain measures for health information exchange, patient electronic access, and other objectives that require patient action.

FAQ 12817
Question: For the Health Information Exchange objective for meaningful use in 2015 through 2017, may an eligible professional (EP), eligible hospital or critical access hospital (CAH) count a transition of care or referral in its numerator for the measure if they electronically create and send a summary of care document using their CEHRT to a third party organization that plays a role in determining the next provider of care and ultimately delivers the summary of care document?

Answer: Yes. An EP, eligible hospital or CAH may count transmissions in this measure’s numerator when a third party organization is involved so long as:

  • The summary of care document is created using certified EHR technology (CEHRT);
  • The summary of care document is transmitted electronically by the EP, eligible hospital or CAH to the third party organization…read the full FAQ.

FAQ 12821
Question: If multiple eligible professionals or eligible hospitals contribute information to a shared portal or to a patient’s online personal health record (PHR), how is it counted for meaningful use when the patient accesses the information on the portal or PHR?

This answer is relevant to the following meaningful use objectives: Patient Specific Education and Patient Electronic Access measure 2.

Answer: If an eligible professional sees a patient during the EHR reporting period, the eligible professional may count the patient in the numerator for this measure if the patient (or an authorized representative) views online, downloads, or transmits to a third party any of the health information from the shared portal or online PHR. The same would apply for an eligible hospital or CAH if a patient is discharged during the EHR reporting period. If patient-specific education resources are provided electronically, it may be counted in the numerator for any provider within the group sharing the CEHRT who has contributed information to the patient’s record if that provider has the patient in their denominator for the EHR reporting period. The respective eligible professional, eligible hospital, or CAH must have contributed at least some of the information identified in the Medicare and Medicaid Programs; Electronic Health Record Incentive Program – Stage 3 and Modifications to Meaningful Use in 2015 Through 2017 final rule (80 FR 62807 through 62809) to the shared portal or online PHR for the patient. However, the respective provider need not have contributed the particular information that was viewed, downloaded, or transmitted by the patient. …Read the full FAQ.

FAQ 12825
Question: In calculating the meaningful use objectives requiring patient action, if a patient sends a message or accesses his/her health information made available by their eligible professional (EP), can the other EPs in the practice get credit for the patient’s action in meeting the objectives?

Answer: Yes. This transitive effect applies to the Secure Electronic Messaging objective, the 2nd measure of the Patient Electronic Access (View, Download and Transmit) objective, and the Patient Specific Education objective.

If a patient sends a secure message about a clinical or health related subject to the group practice of their EP, that patient can be counted in the numerator of the Secure Electronic Messaging measure for any of the EPs at the group practice who use the same certified electronic health records technology (CEHRT) that saw and patient during their EHR reporting period.

Similarly, if a patient views, downloads or transmits to a third party the health information that was made available online by their EP, that patient can be counted in the numerator of the 2nd Patient Electronic Access measure for any of the EPs in that group practice who use the same CEHRT and saw that patient during their EHR reporting period.

If patient-specific education resources are provided electronically, it may be counted in the numerator for any provider within the group sharing the CEHRT who has contributed information to the patient’s record if that provider has the patient in their denominator for the EHR reporting period. … Read the full FAQ.

For more information on accurately calculating the numerator for measures, please visit FAQ 8231.

EHR Certification Termination – What’s It Mean?

Posted on September 10, 2015 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 news recently came out that ONC had terminated the SkyCare EHR developed by Platinum Health Information System, Inc. It sounds like those that were using the SkyCare EHR were likely aware of the issues with their EHR. From reports I read, many customers had already reported that SkyCare EHR was no longer responding to them and the company had basically disappeared.

It’s always sad when this happens even when there are only a handful of doctors using this EHR. You’d think that the founders of the company would have enough integrity to provide their users as soft a landing place as possible. Plus, if they didn’t have enough respect for their users, how about respect for the patients that could be put in harms way without a soft landing. Even with the help of an EHR vendor, switching EHR software is tough. Without them it can be brutal and have all sorts of ugly consequences for a practice.

ONC certainly did the right thing to terminate the company’s EHR certification. If they hadn’t done it, then the doctors would be in an even worse situation. With the EHR certification terminated, the doctors can now apply for the exception which will allow them to avoid the EHR penalties. Of course, that doesn’t help them when it comes to the EHR incentive money which they’ll no longer receive.

I hope this is a lesson for other EHR vendors (and many more will fail). Don’t leave your EHR users high and dry. Do the right thing and help them move to a new EHR system. I’m sure there’s more to the story of why SkyCare EHR was shutdown, but I can’t imagine wanting to ever work with the Founders of that EHR in any other capacity.

Meaningful Use is On the Ropes

Posted on May 9, 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.

We’re entering a really interesting and challenging time when it comes to meaningful use. We’ve often wrote about the inverse relationship between incentive and requirements that exists with meaningful use. As meaningful use stage 2 is now becoming a reality for many organizations and EHR vendors, the backlash against it is really starting to heat up.

If you don’t think this is the case, this slide from the HIT Policy Committee presentation says it a lot when it comes to organizations’ view of meaningful use stage 2.

Meaningful Use Stage 2 Attesatation - May 2014

For those that can’t believe what they’re reading, you’re reading it right. 4 hospitals have attested to meaningful use stage 2 and 50 providers as of May 1st. Certainly it’s still relatively early for meaningful use stage 2, but these numbers provide a stark contrast when you think about the early rush to get EHR incentive money during meaningful use stage 1.

This article by Healthcare IT News goes into many of the strains that were seen in the HIT Policy Committee. Sounded like the healthcare IT version of Real Housewives. However, the point they’re discussing are really important and people on both sides have some really strong opinions.

My favorite quote is this one in reply to the idea that we don’t need EHR certification at this point: “Deputy national coordinator Jacob Reider, MD, disagreed. Ongoing certification is required to give physicians and hospitals the security they need when purchasing products.”

Looks like he stole that line from CCHIT (see also this one). What security and assurance does EHR Certification provide the end user? The idea is just so terribly flawed. The only assurance and security someone feels buying a certified EHR is that they can get the EHR ID number off the ONC-CHPL when they apply for the EHR incentive money. The EHR certification can’t even certify EHR to a standard so that they can share health data. EHR Certification should go away.

I’m also a huge fan of the movement in that committee to simplify and strip out the complexity of meaningful use. I wish they’d strip it down to just interoperability. Then, the numbers above would change dramatically. Although, I’ve learned that the legislation won’t let them go that simple. For example, the legislation requires that they include quality measures.

No matter which way they go, I think meaningful use is in a tenuous situation. It’s indeed on the ropes. It hasn’t quite fallen to the mat yet, but it might soon if something dramatic doesn’t happen to simplify it.

EHR Post Acquisition, 2014 Certified, ICD-10 and the Amazing Charts Future with John Squire, President and COO

Posted on April 30, 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 the chance to sit down and interview John Squire, President and COO of Amazing Charts. I was interested to learn about the transition Amazing Charts has experienced after being purchased by Pri-Med and the departure of Amazing Charts Founder, Jonathan Bertman. Plus, I wanted to learn why Amazing Charts wasn’t yet 2014 Certified and their plans to make it a reality. We also talk about the value of meaningful use and the ICD-10 delay. Then, we wrap up with a look at where Amazing Charts is headed in the future.

Check out EHR videos for all of my EHR and Healthcare IT interview videos and be sure to subscribe to the Healthcare Scene youtube channel.

Interview with ICSA Labs About EHR Certification

Posted on January 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.

After hearing the news about CCHIT shutting down it’s EHR certification business, I thought it would be interesting to interview ICSA Labs, the EHR Certification body that CCHIT recommended to its users. The following is an interview with George Japak, Managing Director at ICSA Labs.

Is there a backlog of EHR vendors that want to schedule test dates with ICSA labs?  

A: There is no backlog. Since ICSA Labs received its ONC authorization, it has been our intent to grow our healthcare programs and offer the best testing and certification program in the industry. Over time we have ramped up our testing team and we have a deep pool of very experienced testers on staff. We have been getting a steady stream of news customers and inquiries and expect the CCHIT announcement will accelerate the pace.  At this point we have the capacity to test applicants as they are prepared to do so.

Is ICSA Labs able to support the onslaught of EHR companies that will come over from CCHIT?  Will that cause any delays on getting EHRs certified?

A: ICSA Labs at this point does not anticipate any delays. The ONC program was designed so that vendors and product developers would have a choice when it came to testing and certification. We were not the first lab to be authorized, but we knew that given the opportunity we would be able to deliver a program where customers would experience high satisfaction.

In my post, I suggested that the economics of EHR certification aren’t all that great.  Especially if you have a legacy cost structure like CCHIT.  Is the secret to ICSA’s success having a broader certification business beyond just EHR?

A: ICSA Labs has been in business since 1989, we have a number of accreditations to support an array of certification and testing programs, such as the IHE USA Certification program which just kicked off its second year at the 2014 IHE North American Connectathon. Our business is diverse and we leverage our capabilities across our business. We are used to doing business in competitive markets, so it has always been important for our programs and cost structure to emphasize efficiency and effectiveness and those benefits are passed onto our customers. Our testing and certification programs have always been competitively priced and efficient yet rigorous and done superior quality.

How much more complex is 2014 EHR certification compared with 2011 from an ONC-ACB perspective? 

A: As any recently certified company can attest to, the 2014 Edition criteria are significantly more complicated than the 2011 Edition. There are more test tools to maintain; more test data sets to review; frequent revisions and updates to the criteria and additional types of attestation to review. The time to complete testing has close to doubled and there are more requirements as they pertain to surveillance. After the 2011 Edition criteria, ICSA Labs asked for ONC to raise the bar, and they did. For ICSA Labs the added complexity was not unexpected.

The timelines for meaningful use stage 2 are starting to get squeezed.  Will the majority of EHR vendors be 2014 certified and ready in time?

A: There will always be stragglers, but I believe a majority of EHR vendors will be 2014 certified and ready in time for Meaningful Use 2. There has been an uptick in the vendors getting certified over the last few months. Providers and hospitals however are a different story, and they may feel the squeeze in terms of the timeline to purchase, implement and begin meaningfully using their EHR system. ONC extended the Stage 2 timeline to relieve some of that pressure.

I’ve heard that in some cases the ONC-CPHL has been slow at putting up newly certified EHRs.  Have you seen this?  Do you have a bunch of 2014 certified EHR vendors that haven’t been listed on ONC-CPHL yet?

A: The ONC-CHPL is generally responsive to our concerns and we work with them as they continue to refine new features like links to the public test results summary.

New Certified Health IT Mark from ONC

Posted on July 11, 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.

One of the keys to a good certification is good branding. Think about JD Power and Associates. When you see that brand, you know what it means and what it represents. For EHR software, ONC is likely hoping that their new ONC Certified HIT mark will do something similar for EHR software.

Here’s the mark you should look for to know if an EHR meets the 2014 Edition Standards and Certification criteria:
ONC EHR Certification - Health IT Mark

What’s in a mark? I think it currently serves two purposes. First, it says if that EHR vendor can help you show meaningful use and get the EHR incentive money. This is the most important part of a good mark. The second is that EHR vendors that have this mark will have conformed to the interoperability standards that are set in the EHR certification process. I’m hopeful that this is the most valuable thing that comes out of EHR certification and meaningful use.

The following is the full press release from HHS about the new EHR certification mark.

EHR products must meet standards and certification criteria to be certified

A new mark for certified electronic health records (EHR) technology was unveiled today by the HHS Office of the National Coordinator for Health Information Technology (ONC). The mark will appear on EHR products that have been certified by an ONC-Authorized Certification Body (ONC-ACB) and will indicate that the product meets the 2014 Edition Standards and Certification Criteria.

Eligible professionals and hospitals must demonstrate meaningful use of EHR technology that has been certified under the ONC Health Information Technology (HIT) Certification Program to qualify for Medicare and Medicaid EHR incentive payments.

“We’ve reached the tipping point of doctors adopting electronic health record systems and using them to improve patient care,” said Farzad Mostashari, M.D., national coordinator for health information technology. “The use of the ONC Certified HIT mark will help to assure them that the EHR they have purchased will support them in meeting the Meaningful Use requirements.”

Electronic health records technology may be certified by one of four ONC-ACBs accredited by the American National Standards Institute (ANSI) and authorized by ONC. The mark is a visual cue that the product – whether a complete EHR, an EHR module or another type of health IT product – meets ONC’s applicable certification criteria and can achieve interoperability, functionality and security. For example, the criteria include such requirements as computerized provider order entry (CPOE), drug to drug and drug-allergy checks, and the capability to coordinate clinical information to help improve the quality of patient care, among others.

When the mark is associated with a certified “Complete EHR” it means that the EHR technology can be used without modification to achieve Meaningful Use. A certified EHR module may be combined with other modules to make a complete system. Some modules may include the ability to:

  • ·         Create a standard patient summary care record;
  • ·         Securely transmit summary care records using Direct, a tool created through an ONC-led collaboration with broad health IT industry participation, that allows for the secure exchange of health information over the Internet; and
  • ·         Provide patients with online access to view, download, and transmit their health information to destinations of their choice.

ONC-ACBs will begin to issue the mark to certified EHR products immediately. To learn more about the terms and use of the mark, click here.

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.