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To Be or Not To Be — Certified; That is the Question
By Frank L. Poggio
The ONCHIT Certification process is in full swing. There are three interim firms designated as Authorized Testing and Certification Bodies (ATCB). Over 100 products and about 70 firms have been approved. The key question is this: should you, as a vendor or in-house system developer, get certified?
I think we all can agree that if you sell a full EMR or EHR system to health providers, certification is a must. If you do not get certified, it is unlikely you will install another new client. Worse, your existing clients will start leaving in droves.
But what if you are a niche vendor? What if you sell a best-of-breed (BoB) package, such as a lab system or a therapy or a dietary system? And what about vendors that sell smart medical devices?
For these situations, according to a strict interpretation of the rules, you do not have to get certified (unless, of course, your clients and prospective clients request that you do). And therein is the rub. ONCHIT is not telling vendors they must get certified before they can sell systems (as does the FDA for blood bank software). ONCHIT is going to let the market tell you.
The potential impact of the Meaningful Use bonus / penalties can add up to millions of dollars over the next five years for a given health facility. The responsibility for realizing bonuses and avoiding penalties will fall on the CIO (or maybe COO) of the health facility. If the facility misses out on a bonus or gets hit with a penalty, it is likely that the responsible executive’s job is on the line.
Given that real personal concern, it is fair to assume the CIO /COO will purchase only certified systems and de-install ones that are not.
Even in situations where a niche product does not directly deal with certification “modules”, it could put meeting MU approval at risk. In a recent discussion about certification by the HITECH Policy Committee, it was explained that if you have a ONCHIT-certified clinical data warehouse and use it to generate quality and MU performance measures, if a non-certified system accesses the warehouse and/or places data into the warehouse, the warehouse could be deemed non-certified. I call it “contamination through association”.
Considering the vast amount of PHI and clinical data that moves daily to and from interface engines while finding its way into, and passing through, multiple systems, you can see where a CIO/COO would not want to take a chance on a non-certified product, regardless of how insignificant the application may be to the overall facility’s operation.
This “contamination” issue is not unique to facilities that favor best-of-breed solutions. It cannot be avoided by purchasing an EMR from a single vendor since no single vendor covers the complete waterfront for all applications needed by a provider.
In fact, many medical device vendors will be faced with the same challenge. For example, if a device such as an IV pump, drug dispensing cabinet, or digital imaging equipment is considered “smart” (that is, receiving and communicating patient information and communicating the data over the core hospital infrastructure), then if the device is not ONCHIT-certified, it could be deemed as a potential “contaminator”, thereby rendering the entire EMR as non-compliant and not eligible for MU. Remember: fail just one criterion and you don’t get a bonus.
Unfortunately (or fortunately, depending on your view), there is a now a new cost of doing business in the health systems marketplace: ONCHIT certification. The unfortunate outcome may be that this is a new barrier to entry and will scare off new HIT startups while further embedding the current ones.
The second challenge for a niche IT vendor or device manufacturer is navigating your way through the MU “module” tests. There are 44 certification criteria today. Additional ones are promised for Years Two and Three that will increase the list by orders of magnitude. As a niche player, your product(s) is considered an “EMR Module” and does not have to meet all test criteria. You are required to meet eight privacy and security tests and just one of the remaining 35.
But this may create a real competitive concern. What if you are a BoB vendor or have a smart medical device and none of the 35 criteria apply to your application? From a regulatory standpoint, you do not need to go through certification. Yet your arch-competitor’s application touches just one module criteria and they submit on that one along with the eight P&S criteria and get certified. Whose product or software will the CIO be most comfortable with?
On the surface, you may think it best to try to meet as many criteria as you can, but there are real risks and costs in doing that. Selecting which to pursue, and which to pass on, must be both a strategic marketing and critical development decision.
In summary, it’s hard to see how a niche player can avoid diving into this pool. The more important question is — how deep?
Frank L. Poggio is president of The Kelzon Group.
Is Your Vendor About to Deflate?
By Alan Jack
One of the problems in HITland is the inability of many vendors to hire and keep talented staff, especially in the R&D area. Compared to other sectors , healthcare software companies pay lower salaries, need folks to stay on call 24 hours a day, have long hours, etc. Many vendors do not have great internal cultures, either. The result is that many companies have a reputation problem.
When demand for software developers is good, HIT companies start having problems recruiting, while at the same time, headhunters are targeting their employees. Added to the normally high turnover in the software industry, the losses can start snowballing as workloads go up and more folks bail. Developer numbers will start shrinking despite efforts to recruit more. Software will be delayed just at the time when it is needed most.
Do not think that the vendor will willingly disclose issues with customers. The total headcount at companies experiencing issues will likely be going up, in fact, as other roles are hired: project managers, sales and marketing, and other folks in the easier-to-recruit categories. Employees will often switch roles in those time periods, requiring backfill.
As the economy comes out of the Great Recession, this will become an increasingly difficult problem to deal with. Several companies I’m familiar with are already having issues recruiting.
Given that software developer degrees area unpopular with college students at the moment and the reputation problem companies are having have spread overseas to areas where H1B visa people are recruited, don’t look for things to change soon.
Back to School For a Master of Biomedical Informatics Degree – Part II
By Jeremy Harper
Many HIStalk readers are past the career stage where education adds life-changing value. In fact, they are the men and women who will be interviewing and hiring students in the upcoming years.
This post will discuss the differences students will offer from someone who has experience, but no formal education. It will also discuss some of the general education required for a MBI. Lastly, it will briefly mention internships and how a proactive company could interact with students who would be more inclined towards working at their company upon graduation.
As you saw in my introductory post, I am at the beginning of my career. While I have seen a rapid progression in my career, having entered the full-time healthcare work force in 2007, it would probably take an additional 20 years of experience and luck before I could become a CIO without higher education.
What this degree shows for me — and every other student — is that the person receiving it has a passion for the industry. It shows that that the student is willing to take years out of their life to receive a breadth and depth of knowledge that cannot be equaled solely by work experience. It shows they can determine a long-term goal and marshal the necessary resources to achieve it. These are valuable skills to consider when hiring these students to senior team member and management positions.
As someone with experience at both a vendor and a hospital system, I know the value that real-world experience offers. However, that same experience has a narrow focus. A formal educational setting is changing my perspective on past work to look beyond the scope of the project to see how it fits into the overall arena.
This quarter in pathophysiology, for example, we’re doing clinical reviews every week with a physician. We learn how to do the same types of HX&PE medical students perform (lacking their expertise, of course). We will also shadow a healthcare provider with the specific goal of observing their workflows and reporting them to our fellow students.
The people leaving these degree programs will educated in a variety of different methods, but they will have the ability to adjust and learn to use any system necessary to accomplish a goal. Students learn about disparate topics like database structure, biostatistics, and report writing. This provides a confidence to accomplish more than a work force operating solely on experience.
As a real-world example, I have interacted with two separate interface teams closely in my career. One had exceptionally practical experience, having learned via the school of hard knocks. The other also had practical experience, but also formal clinical education prior to working with the interfaces.
The former team would not modify any data pushed through the interfaces. The closest to modification they would come was translation tables. The latter used their specialized knowledge and depth of understanding to successfully accomplish a stronger interface between two systems that did not inherently talk to one another or have data that could be simply translated with a table.
To close, the OHSU program requires two quarters of real-world internship in whatever specialized field the master’s degree student chooses. In general, the other programs I investigated also required some type of internship and capstone.
These programs had a wide variety in what they were looking to accomplish with the internship. Many past projects from my research were evaluations of an EMR implementation, assisting with EMR implementations, working for software vendors on improving their product, or doing general research for scientific endeavors.
If you have a school in your area (check here)or an internship that can be done remotely, you can start forming professional relationships with these schools and students that will enrich your work force.
Jeremy Harper is a student at Oregon Health & Science University of Portland, OR.