Cloud Based EMRs: Better Post-FDA-Approval Research

A recently closed longitudinal study of a medication to boost “good” HDL cholesterol concluded: “… that the HDL-boosting drug niacin failed to cut the risk for heart attacks and strokes.” The study was designed to track patients for 4 to 6 years but was terminated 18 months early based on the results to that point. The cost: $52.7 million or $15,500 per person for the 3,400 study participants. Fully networked, cloud based, electronic medical records (EMR) appear to offer a better solution.

The topic of this post is research about medications that have received FDA approval and are being prescribed for general use. The subject of a research study could be a new medication being tracked for purposes of risk management among patients who were not fully represented in the limited sample used to obtain FDA approval. It could also be an established medication where adverse events are suggesting that more needs to be learned or where there is reason to believe it is not significantly effective to justify continued sale. In this case, it was a matter of both effectiveness and risk.

The key to a better solution is the evolution of fully networked, cloud based EHRs that create a database that is large enough to provide meaningful statistics about specific occurrences. As an example, Practice Fusion now hosts electronic records created by 90,000 medical providers in a single database that has more than 12 million patient records and is growing. The data is being collected as part of physicians’ normal practice—the electronic version of historically hand written notes.

There are operational advantages:

• Data collection is conducted to serve the day-to-day needs of the physician and their staff so they have established procedures and a vested interest in quality.
• The use of the data is totally independent of its collection so there is no bias in the data collection process or the data; neither the doctor nor the patients are even aware of how the data may be used: a totally blind process.
• Separation of data collection and use remove any presumption of undue influence by the sponsor of the study.
• Data is uploaded by physicians daily so it can be made available in near real-time for use at checkpoints in the study.
• If an area of particular interest is discovered, e.g., women over 60 who are more than 20 pounds overweight, additional participants with those characteristics can be identified and added to provide a larger, more reliable sample of that group.
• The study can provide information about risks and effectiveness, increased levels of HDL, and continued use, i.e., prescription renewal.
• In many cases, patient history related to their disease including prior medications is available and information will be available about patients who stop taking the medication or change to a different medication.
• The same database can be used to create a control group of patients that are not taking the medication and have essentially the same medical conditions and demographics as those who are; if a member of the control group begins taking the medication they can be moved to the study group and replaced in the control group—there is no need to deny patients the opportunity to take the medication just to protect the integrity of the data.

The largest benefit is that there is no marginal cost for data collection. The data is already being collected. There are, of course, charges for extraction of the specific data required for the study, for HIPAA compliant de-identification of the data, and for the use of the data. The study costs cited in the introduction, $15,500 per participant, include costs in addition to data collection, but data collection is a major part of that cost and could be dramatically reduced through the use of fully networked, cloud based, electronic health records.

Better data for the reasons noted above at lower cost translate to better healthcare at lower cost.

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Medical Records Are Just One Form of Healthcare Information.

In just a few years medicine has taken major steps to move from paper records in individual doctor’s offices to electronic medical records that can be shared with patients and their other physicians. The primary point of coordination of care among a patient’s physicians is moving from the patient—I saw Dr. Adams last month and he told me…—to the patient and her team of physicians who share the same records. The good news is each physician now has more information; the bad news is they have no additional time to analyze it. That is the tip of the iceberg.

At the same time, the marketplace has seen the value of health related information and is rapidly creating new ways to collect that information. Sources as diverse at private individuals working on smart phone apps to corporate giants like Ford Motor, Intel and General Electric are creating new ways to capture more and more health related information. Most of this will be routine but some of the haystacks will have needles of data critical to a healthy future for some patients or even life savings requirements.

Physicians can choose what medical information to collect depending on each patient’s specific circumstances; they can decide what is relevant and influence the volume of physician generated medical information. Patients will make the decisions about the information to be collected from many of the marketplace solutions: Here are my vital signs taken during my bicycle ride last week when the temperature was 89 to 95 degrees and I climbed 1321 feet and averaged 13.2 miles per hour. Here is the data from my Ford car last month and the statistics Intel/GE captured with regard to when I took my medication and how I answered the phone. How good is the data? Are there any needles of critical data?

We are rapidly moving from inadequate amounts of data to overwhelming amounts.

Prior solutions are the source of almost all significant problems. There is a problem on the horizon and now is the time to explore ways to manage the growing amount of data being generated and shared within the medical community and the marketplace. The people who are harnessing computers to capture medical data may be the logical ones to develop ways to capture, assess, integrate and analyze the growing amounts of data or the solution may be out in the marketplace. Stay tuned.

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Prediction: Pharmaceutical Litigation

Pharmaceutical litigation is where huge lawsuits are common. I predict that this will change and the change will reduce the damage to the bodies and lives of patients, reduce the cost of healthcare, and speed up the process of moving new medications from the laboratory to patients. What will cause that change?

Historically, the pharmaceutical manufacturers have been responsible for the collection, analysis and distribution of data related to benefits and side effects of new medications. Data collection has been an extra cost of doing business. Like all costs, there is pressure to minimize these costs. If, and when, publicly available data including anecdotal evidence begins to point at a serious problem, the plaintiff’s bar also begins to develop data about risks and damage.

The cost of data collection using today’s methods imposes economic limits on the amount of data gathered by manufacturers. Cost control argues for the smallest amount of data that will likely be required, but how much is that? The smaller the data sample the less likely it is that a risk will be identified early in the life of a new medication. If a risk is limited to just some patients, a small total sample makes it unlikely that a risk to a sub-set will be identified, e.g., males over 70. If the total sample is statistically small, a sub-set will be even smaller and less reliable as an indicator of both the need for action and as a guide to appropriate action.

The push by the federal government for healthcare providers to shift from paper records to electronic healthcare records (EHRs) has been seen as a potentially slow process. The common model assumes EHRs will be implemented first in hospitals and then spread to private practices because of two factors: first, the cost and complexity of the required computer systems, and second, the lack of the standards required to move meaningful data from system-to-system for consolidation and analysis.

The maturation of the Internet in terms of processing and security now means that data can be safely moved and stored. Cloud computing—remote data processing and storage—now allows service providers to grow new services rapidly without large up-front investments. The net result is a dramatic reduction in cost for the service provider and users, e.g. physicians. As an example, one company, Practice Fusion, provides a full function EHR to private practices totally free. Step one in the changes that are occurring is unexpected reductions in cost.

Hospitals generally have short term relationships with patients whereas private practices generally have longer term relationships. Private practices monitor more patients over longer periods of time than hospitals. Step two is a shift from hospitals first to private practices first for widespread implementation of EHRs which will provide better longitudinal data about the effectiveness and risks of new medications.

The original model for EHRs envisioned small libraries of patient data sitting on the hard drives in the offices of thousands of doctors. Solutions for the nightmares associated with moving and consolidating all of that data are still on the drawing boards. Rather than “stand-alone” systems, the Internet and cloud computing allow the use of a common set of databases and a single set of standards. As an example, Practice Fusion now has seven million patient records from 70,000 medical professionals in their database. That is nearly 10% of all of the doctors in the US and growing rapidly. The data from thousands of doctors is being monitored as it is received. The data is all in a common format and is available for analysis and reporting in near-real-time. Step three is the availability of large databases with one set of standards that dramatically reduce the time and cost required to convert data to useful information.

The data that was formerly collected by the manufacturers as an additional cost of doing business is now being collected as a routine part of patients’ visits to their healthcare providers. There is little or no extra cost to track a new medication. The data is being collected by nurses and doctors trained in diagnosis and documentation as a normal part of their medical practice. Step four is further lowering of costs; step five is better quality data.

The availability of more, better, and cheaper data at lower cost offers opportunities to reduce the risks associated with new medications and may allow regulatory agencies to approve new products with less research subject to close tracking and third party analysis of results. Lower cost of research and earlier to market could represent significant cost savings for new medications.

As a new medication enters the market feedback about its effectiveness and risks will begin to flow very shortly thereafter. Manufacturers who chose will be able to measure and document effectiveness and will also be able to identify risks. As the patient population using the medication grows, the sample being tracked will also grow. This means that that as risks become significantly large—however significance is determined—the data base will be growing to support both risk assessment and mitigation. Manufacturers, if they chose, will have new opportunities to minimize damage by providing additional information to the medical community and patients and to develop specific responses to specific problems. Timely action will reduce compensatory damages and responsible action will reduce punitive damages. Timely responsible action will reduce damage to the brand in the marketplace.

Manufacturers who chose not to participate in the analysis and application of this data will probably find that plaintiffs’ attorneys are using the data to find opportunities for litigation. The plaintiffs’ attorneys will probably argue that the reluctance of manufacturers to make effective use of the data justifies demands for increased punitive damages.

My prediction: more, better, faster, and cheaper data will speed up the process of moving new medications from the laboratory to patients, reduce the cost of healthcare, and reduce the damage to the bodies and lives of patients who have adverse reactions to new medications. Changes in the way that healthcare data is being collected, processed and stored will reduce both compensatory and punitive damages related to pharmaceutical litigation.

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If I Were A Doctor … Impatient Patients

There have been a number of articles recently about the changing relationship between doctors and their patients, or what might be called their “impatient patients.”

As an impatient patient, why should I have be at your office for my first visit 15 to 30 minutes early to deal with paperwork that is essentially the same as I have filled out for every doctor I have ever visited. Give me a standard set of forms. Post them on your Web site and let me download them so I can do this one more time and then just update as necessary for future doctors. You and future doctors are asking for information about me; give me a tool and I will take care of that.

Better yet, help me find them in a place like Google Health or Microsoft Health Vault or somewhere similar. After I make the appointment, I can review the forms, fill them out and send them to you. Have a general medical set, insurance set, HIPAA set, specialty set, etc. In the future I may have to fill out a new form for a new specialist and update a couple of fields but that is easier than filling out every form for every doctor. In any case, let me do it on my free time rather than as part of my appointment.

It could also include a list of recent tests and a history of standard things like my weight, blood pressure, etc. that could be accessed in advance. If my standard form shows that I had a PSA test in 2009 and the reason I am coming for this appointment might make my PSA level of interest, your system (or assistant) could have that information in the office when I arrive.

One of these forms should also give you a list of my other providers in case you need to communicate with any of them before my appointment or want to send them a follow up report. Or better yet, let me know that you can use the list already in my Google Health file which includes specialty, addresses, and phone numbers.

It should include a list of my meds from Google Health or a similar service. This will give you accurate data from my pharmacist that is date stamped so you can see what I have taken and am taking. Almost certainly better than the records I bring with me today. Saves me some more time and you get better data. That will also give you information about my pharmacy of choice.

Send my prescription to my pharmacy of choice. Why should I have to make two trips to the pharmacy? One to drop it off and one to pick it up or wait 30 minutes. I want to make just one stop and not have to wait to pick it up.

We all know doctors run late. You truly have life threatening emergencies. But that doesn’t mean I should sit in your office if I have something better to do with my time — I almost always do even if it is to go someplace private and make some phone calls. (Don’t you hate it when people make cell phone calls in your office?). If you are going to run 30 minutes late, have your appointment system or assistant call me as soon as you know. Ask me if I would like to be notified if you are delayed further, push “1” for yes or “2” for no.

If you get lucky and make up some time and get to your office before I do, take care of the little old lady who was scheduled after me but has been sitting in your office for more than an hour because she doesn’t have a cell phone. She will appreciate it and I will appreciate the reduced impact of your unavoidable lateness.

Stay open to iPhone apps and other tools that will help both of us make better use of our time. Not for all of your patients — that day is probably somewhere in the future. But start using it now. You and I other adventuresome folks can experiment knowing that we will encounter a learning curve to be climbed.

I know you have better things to do than play on the bleeding edge of technology. On the other hand, if I work through the learning curve with one of my other doctors, I will expect you to have it right the first time we use it. And, if I start with you, I will be trained to do it your way. If you are reading this, I would rather work with you.

If I Were a Doctor … EMR

If I Were a Doctor … EMR

Several doctors I know have asked me for advice on buying an Electronic Medical Records (EMR) system. Here’s my advice:

Start with a network of other doctors in your specialty. You don’t have the time to do all the research and evaluate all the options on your own. You will also need that network after you purchase the system. An ideal network for this is probably between three and six doctors. If a doctor you know has an EMR that she likes, start there and then check the rest of my recommendations.

A network will give you better points of view and more resources to make the buying decision. If a vendor knows that a sale to one will probably lead to a sale to several they will work harder at assuring you that the system meets your needs. They will also be more willing to consider changes or enhancements if that will lead to multiple sales.

After the sale, there will be issues. If several of you have the same issue, you are more likely to get prompt vendor attention. If the issue can be solved by training, your staff can work with staff from the offices of the other doctors to share what they know. For this reason, I would bring the person in my office who has the best attitude toward computers with me to some of your network meetings and suggest that others do the same. Computers can make people feel very stupid. It helps if you can call someone you know for help or take a call to give help.

Get the service via the Internet. You will have to have computers in your office but data will be stored off-site, problems can be addressed remotely, and system will be kept current. A vendor will provide redundancy (backups), secure storage, and should have better general security than on a stand-alone system. HIPAA and other regulations are applicable.

Insist that all programs are written in one of a number of common programming languages and data is stored and accessed using SQL. If you need to migrate to a new system – EMRs are still in their infancy and change will happen – it will be easier if everything uses standard parts and solutions.

Listen for flexibility when the vendor talks about the system. There are new products coming, think of the iPad. Google Health and Microsoft Health Vault are adding features and functions. Your patients are using the Internet to make better use of their time; they will expect you to support that. Simple example, have the capability to post your reports on their personal health records so they can share them with other doctors so they don’t have to take the same test over and over. Sometimes this will be with doctors who do not even have systems and you probably don’t know. Today, that takes several phone calls and a FAX or two. Way too time consuming. They also own the data and you need to help them use it responsibly.

Expect online help to come with the system. Your staff should be able to learn to use the system with a combination of basic computer skills plus online documents on the system. Not the best way but you can’t send every new-hire off to a class and routines that are not used get forgotten. Example: Change a patient’s name when they get married so the old and new records are continuous? Add a new doctor to the practice? Change a staff member’s password?

Have one doctor’s office install first and check it out. With orders waiting in the wings they will get better service and all of you will get to watch the system and the vendor in action. Send the person in your office with the best attitude toward computers to sit in on some of the training sessions and to get some practice. Get the administrative parts of the system stable in each office before the doctor’s in that office start to use the system. It is easier to fix administrative records and staff downtime is less expensive than doctor time.

No guarantee of success or satisfaction, but that is always true with computer systems. These steps will improve your odds of getting a system you and your staff will like and find useful.