Posted by Yehuda Bechar on Mon, Nov 08, 2010 @ 12:56 PM
In the wake of the HITECH Act, which encourages healthcare providers to use Electronic Health Records (EHR) through subsidies and reduced Medicare payments, patients may know that providers routinely store and transmit electronically their personal health-related information. Patients with chronic diseases might, however, be surprised to learn that many aspects of their medical care, from the interpretation of lab results, to medication dosage calculations and treatment recommendations, are increasingly handled by software instead of clinicians.
Chronic Disease Management Software (CDMS), like CoagClinic by Standing Stone Inc. and UM-developed AviTracks by Avicenna Inc., either integrates with EHR or works in its place, guiding clinicians through each step of their workflow. CDMS typically leads clinicians through patient enrollment, assigns medication dosages based on medical history and drug interactions, aids in scheduling lab tests and clinic visits, automatically alerts clinicians about problematic lab results and missed appointments, and recommends treatment based on standardized treatment protocols. Thus, with CDMS, clinicians are outsourcing some of their most important functions like medication dosing, lab interpretation, and treatment decisions to software programmers. Considering CDMS is often used in anticoagulation clinics, where patients take warfarin, a risky anti-clotting drug with many adverse interactions, also used as rat-poison, it might seem problematic that important dosage and lab-interpretation tasks are largely left to programmers.
So far the FDA, which has authority to regulate devices “intended for use in the . . . cure, mitigation, treatment, or prevention of disease,” 21 U.S.C. § 321(h), has declined to regulate CDMS or related Health IT. This is somewhat inconsistent with its past statements on medical software.
In 2002 the FDA released unofficial guidelines for manufacturers whose medical devices incorporate software, in their General Principles of Software Validation. This guidance document specifies how manufacturers can comply with 21 C.F.R. 820, which requires that software undergo validation, design reviews, and testing. The FDA justifies these requirements for software by noting that 7.7% of all medical device recalls were due to software failures, and “the vast majority of software problems are traceable to errors made during the design and development process.” They conclude that “software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering.”
In the 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the FDA issued additional guidance, this time requiring premarket approval for devices incorporating software. This guidance document outlines steps that a manufacturer must complete before the FDA will initially approve a device, including analysis of the device’s “level of concern,” hazard, design, and software verification and validation. Despite arguably having jurisdiction by the plain language, The FDA does not require pre or post market approval of CDMS or EHR software, instead leaving governmental oversight in this area to the Office of the National Director for Health IT.
One potential explanation is that the FDA is backing off CDMS, and Health IT generally, due to the enormous potential for cost savings and thus lower provider fees. CDMS significantly limits bad outcomes due to clinician errors, thereby improving patient outcomes and clinic efficiency, and reducing exposure to malpractice liability. CDMS is somewhat unusual in its potential to lower healthcare prices. Most new medical technology adds to the cost of healthcare, as patients demand the newest treatment technology and clinicians seek opportunities to charge higher fees. Additionally, because of this industry’s youth, CDMS manufacturers, like UM’s Avicenna, are likely to be smaller than the typical medical device manufacturer. Burdensome regulations may stifle development in this new dynamic market. Perhaps the FDA has recognized that in order to capitalize on CDMS’s huge potential benefits on patient outcomes, which will slash provider’s costs and ultimately prices, they must hold off imposing extra costs into the manufacturing process, at least in the short term.
Written by: Daniel Seidman
View Original Posting Here
Posted by Yehuda Bechar on Thu, Sep 16, 2010 @ 10:20 AM
No one asked (well at least not publicly), but I wanted to share my opinions on what EMR vendors should be doing in regards to EHR certification. I guess you could say this is a small sample of the advice I’d offer as an EMR vendor advisor albeit not EMR vendor specific and with less detail. Take it for what it’s worth.
If I’m an EMR vendor today, I’d definitely avoid going out and getting either the CCHIT Certified 2011 or the Preliminary ARRA 2011 EHR certifications. One reader of this site emailed me an estimate of $100,000 up front and $9,000 renewal fee per year for the CCHIT certifications they were considering. Certainly it could be less if you just go with the Preliminary ARRA certification, but regardless the cost is quite large.
Instead, I’d take a more reasoned approach. There are 2 important things for an EMR vendor to consider when it comes to EHR certification.
1. EMR vendors need to be able to sell product and allay customers concerns about your EMR not being certified. Many people will be asking for EHR certification and even more people will be asking for the EHR stimulus money.
2. EMR vendors want to make sure that they’re well positioned to become HHS certified (at least most of them) once HHS pulls back the curtain and shows us what that will be. However, they don’t want to waste development dollars on features that don’t improve their product.
With these two considerations in mind, my suggestion is for EHR vendors to take a look at the Preliminary ARRA Certification (in particular the Meaningful Use Matrix Tagged for CCHIT Reference document (pdf) is a good start). Take the list of criteria that CCHIT has created and matched up with the meaningful use matrix. Then, evaluate the criteria to see which ones you don’t have and would be of value to your customers. Next, prioritize that list and add those criteria that add value to your EHR development plans.
The concept is simple. Despite my ripping on CCHIT, there are certain aspects of their criteria that are incredibly valuable to a doctor’s office. Take those criteria that will provide value to your EHR end users and spend your development time adding value to your product. Then, once HHS/ONC/CMS publishes the final criteria for achieving EHR certification you will have hopefully already developed a number of the criteria while not wasting time developing CCHIT criteria which won’t be required by HHS/ONC/CMS. Once we know what the real EHR certification criteria is going to be, you can decide which “certified EHR” option is best going forward.
There is one caveat to this suggestion. You’re going to have to be able to tell a compelling story to some clinics about why you aren’t doing CCHIT certification. However, from what I’ve heard from other EHR vendors and my experience talking to people, it’s not a huge hurdle to explain how you’re going to get them access to the EHR stimulus money and how CCHIT certification would have increased the cost of your EHR product while not improving the life of the doctor. Let them know that you evaluated the CCHIT criteria list and implemented those of value. Then, list one CCHIT criteria that doesn’t add value and they should see pretty clearly why you made a good choice.
What do people think of this advice? Does it make sense? Is there something else I’m missing?
Posted by Yehuda Bechar on Mon, Sep 13, 2010 @ 09:22 PM
Much has been made of the introduction of Electronic Health ( or Medical ) Records as a means of controlling health costs and improving quality. Despite the medical community’s quick embrace of technology to treat disease, physicians have been reluctant to adopt medical records to the same degree as other technologies. Many have characterized physicians as stodgy curmudgeons, stubbornly clinging their antiquated, overstuffed records in the face of rapidly evolving times. The reality is that you cannot throw a stone in a hospital or medical meeting without hitting a physician with the latest version of the iPhone, reviewing the latest online reviews of apps, laptops, or professional software. To the contrary, physicians are some of the most easily captured consumers for personal technology and conveniences in the marketplace.
As a physician, I can tell you that the commodity most cherished by every doctor is his or her time. Idle time means not only one less patient seen or procedure completed, but one more dinner at home or school recital that is missed. My happiest days are one where one clinical task flows seamlessly to the next—no waiting for an operating room to become available or records to be faxed. Yes, the holy grail of a physician’s workday is one that is busy, productive and ends at a reasonable hour.
So why would so many practices resist adoption of medical records to the point that the government has to not only pay a practice to buy one, but also penalize one that doesn’t? If you ask them, they will say that a complete paper chart is a more efficient use of time than a complete electronic chart and I have to say that I agree. One can peruse an organized paper chart and identify relevant information in the same amount of time for a desktop to boot up. The other reason is that many of the day-to day tasks of follow up or delegated to nurses or clinical staff and their mental care algorithms imbedded by their physician supervisors. EHRs return some of these follow-up tasks back to the physician, which takes time, and thus less revenue and fewer recitals.
Mind you, I am thankful for EHRs I do not miss the days of going to the microbiology lab and looking through the logbook for my patient’s culture results. It is a wonder to view X-rays on a computer screen, though I slightly miss annoying the file room clerk by incessantly pressing the call button at the front desk. But alas, these revolutionary features are no longer a wonder of technology, but an expectation in an i-everything world.
What physicians need is a smarter EHR. A system that does more than collects and organizes information. It needs to know what information I want as soon as log in. A system that knows how I like to treat patients, my patterns and my particulars. It needs to know when a patient is sicker than the other. It also needs to remember treatment plans when my nurse is on vacation or takes another job. It also needs to communicate with my staff, my referrings and my patients. It also needs to minimize my time in from of a computer.
Sure, a smarter EMR makes my life easier, but how is it good for patients? A smarter EHR ensures compliance by standardizing care and thus minimizes errors. Sound medicine requires a human element, but a smarter EHR can keep me updated on new treatments, and remind me or my staff when straying from our usual standards. The Smarter EHR operates proactively for the patient.
The current crop of EHRs was designed to collect and organize data into one place. To do this they had to be heavily structured and expensive. It is time for a flexible, smarter and yes, inexpensive EHR that actually helps caregivers take care of patients.
Posted by Yehuda Bechar on Mon, Jun 07, 2010 @ 03:12 PM
First lets define "chronic condition". There are many definitions of "chronic condition", some more expansive than others. I would characterize it as any condition that requires ongoing adjustments by the affected person and interactions with the health care system.
As I mentioned on a previous blog (Chronic Disease Management and Adverse Drug Events) the care of patients with chronic conditions needs to be improved and streamlined.
Some deficiencies that exist today include:
• Rushed practitioners not following established practice guidelines
• Lack of care coordination
• Lack of active follow-up to ensure the best outcomes
• Patients inadequately trained to manage their illnesses
Most of these deficiencies exacerbate when the volume of patients seen by health care professionals (physicians, nurses, medical assistants) starts to increase. After all it would be very easy to take care of 5 or 10 patients. But when a single professional needs to take care of hundreds of patients the quality of care and attention to each patient starts to fall. There is no single way to improve the quality of care in chronic settings. An effective chronic disease program requires systems that can identify patients, track their progress and invest them in the care process. But, most health care systems are set up for acute, reactive care, not proactive care of patients with chronic conditions. The same is true for most EMR's (that were created on those settings) they are great at identifying and gathering information on a single patient. But what happens when your organization needs to deliver care to hundreds or thousands of patients.
• Is the typical EMR enough?
• Does it really work the way you do?
• Does it make the work of your staff easy?
• Does it improve the efficiency of your staff?
• Does it let you set treatment plans at the granularity that you desire?
• Does it ensures that every single patient receives the care and is monitored following standardize procedures?
• Does it let you coordinate care among primary care physicians and specialists?
At this point I have to start writing about AviTracks and how we at Avicenna tackle all this issues.
To be able to improve the quality of care for chronic disease patients a new kind of clinical application needs to be use. And that is exactly the setting where AviTracks was born. AviTracks was initially developed by the University of Michigan Health System to take care of anticoagulation patients. With the success experience on that setting other care units started to ask for a similar applications. That is when the founders of Avicenna realized there was a real need out there that was not met by regular EMRs. Avicenna took over the task to develop a single application that would cover the needs of all those specialties: Oncology, Rheumatology, Gastroenterology, Pulmonary, Hepatology, Nephrology, Dermatology, to mention some. That is how AviTracks was borned, it never intended to replace and EMR but to provide the functionality and the work-flow that specialty clinics could not find and needed in order to be more efficient.
AviTracks combines:
Patient-centered care, Evidence-based care, and Population-based care.Patient-centered care: Every patient received the care related to his/her specific condition and risk level. Pertinent information, education, and responsibility is given to the patient to allow them to get more involved in their own care. AviTracks also allows you to share information about treatment plans a current condition with other providers and let anyone take action (creating automatic notifications to all parties involved in the patient's treatment) making easier to coordinate treatments.
Evidence-based care: Numerous studies have shown that physician practice patterns vary widely, even where highly effective, cost-efficient treatments have been identified (for example, prescribing beta blockers after a heart attack). AviTracks let you implementing evidence-based care and compare the results for different treatments or different teams within your institution. AviTracks helps you identify best guidelines, practice policies, and clinical pathways.
Population-based care: As we have mentioned AviTracks lets you satisfy the health care needs of all your patients, even the patient who hasn't set foot in your office for years. This goes against the natural tendency of most health care systems, which is to focus only on the acute problem of the patient sitting in the exam room, never mind the problems lurking in the shadows. What population-based care requires is that you: 1. Identify who your patients are and what conditions they have (a patient registry) and 2. Monitor their care proactively. The second part of population-based care is being proactive and keeping patients from falling through the cracks.
Posted by Yehuda Bechar on Fri, May 07, 2010 @ 09:37 AM
Do you want to get the stimulus money? Of course, every body wants to get a piece of the pie. But that money comes with some strings attached. Your organization needs to demonstrate the use of an EMR within the Meaningful Use criteria.
As you probably know the government is rolling Meaningful Use in stages. With stage one focusing on the use of an electronic systems to capture patient's information and the ability to share that information across different platforms. But on this stage the actual sharing does not have to take place, in fact is still obscure how this sharing is going to take place. But well that is why there are stages, so we don't have to figure out everything from the beginning. I am sure that as more clinics (big and small) start using EMRs with the sharing capability embedded we will see the rise of local agencies that will collect and distribute the information.
We need to remember all this effort (and money) is just to be able to be more efficient at taking care of the ill. And that has been our motto at Avicenna from the beginning. We created this company around the idea that there is always a better way to do things. We are always trying to maximize the use of your resources (health care professionals and supporting staff) to be able to bring down the cost while providing excellent care. We specialized on the care and support of patients with chronic conditions.
We have demonstrated just that with AviTracks. With the help of AviTracks one clinic was able to triple the number of patients while maintaining the same number of staff. But that is not all, thanks to AviTracks the number of adverse events even decreased. You can read our sucess story.
Posted by Yehuda Bechar on Mon, May 03, 2010 @ 10:39 AM
Here are the facts:
"One of six Americans who visit emergency rooms due to adverse drug-related events will need to be hospitalized. Drugs that commonly require monitoring in outpatient settings accounted for over half of all unintentional drug overdoses that resulted in an emergency room visit. With monitoring, clinicians can adjust the patient's dosage to prevent avoidable adverse events."
The research also found that among those aged 65 and older, 87% of all hospitalizations from unintentional drug overdose were due to drugs that commonly require outpatient monitoring. Over $85 billion is spent each year to treat drug-related problems caused by misuse of drugs in the ambulatory setting.
This study just reveals the need for a better and more efficient way to follow up patients with chronic conditions that require close drug monitoring. Chronic disease management should be a priority for any specialist after the patient leave their office. Correct and timely drug monitoring can prevent liver damage, kidney damage, thyroid problems, heart attacks, and death.
Would be nice to have a tool that would make this process easy, painless, and cheap. That is how and why AviTracks was created. We started in the anticoagulation setting almost 10 years ago, but quickly discovered that warfarin was not the only drug that needed close monitoring. That is why AviTracks gives health care professional the ability to configure any drug and the protocols related. Not only that but patients can be stratify accordingly to their risk and different course of treatments can be assigned to each patient automatically. Once the drug and the protocols are input AviTracks does the rest. Alerts for out of range labs can be set by patient and physician as well as reminders for due labs and incoming results.
If you are interested on learning more about how AviTracks can help you practice contact us. We will be happy to set up a on-line demonstration for you.
Posted by Yehuda Bechar on Tue, Apr 20, 2010 @ 07:45 PM
How can I make sure all my patients have the information they need to be safe?
That is a common question we get from many of our clinics. We develop chronic disease management software with configurations for many different specialties. But one thing they all have in common is the education page.
The education page is an integral piece of the patient's enrollment process. That is how we "guarantee" that all patients received the same information. At the end of the education page there is also an option to print a welcome letter that states all the information that was given to the patient.
It is also a good idea to include in this section the policies and procedures of your clinic. That way patients are aware of what is expected from them. It is a good place to remind your patients that their care is mostly in their hands and that their wellbeing will depend mostly on them. At the end this document constitutes a contract between your clinic and your patients.
It will serve you well in the future and can even prevent unjust litigation in the future.
If you need a starting point for your clinic or want to make sure you are covering all important point please download this sample.
Posted by John Cunningham on Sat, Mar 13, 2010 @ 11:43 AM
Good and Bad News on Hypertension in US from Heartwire
October 13, 2008 (Bethesda, MD) — A new report looking at hypertension during two time periods 10 years apart has found that more US adults have high blood pressure than ever before. The prevalence has increased from almost 25% during the first period surveyed (1988–1994) to 28.9% during the second period (1999–2004). The findings, by Dr Jeffrey A Cutler (National Heart, Lung, and Blood Institute [NHLBI], Bethesda, MD) and colleagues, are published online October 13, 2008 in Hypertension [1].
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