Personalized Medicine: The Process

I have this theory that we (healthcare) could learn from retail in terms of customer relationship management, in a variety of ways. For example, in retail, almost every store has a “Top Customers” report that lists their top customers over the past year, month, and week. They calculate “top” by total purchases and by the number of customer visits to the store or web site. In theory, retail companies treat these “Top Customers” differently, either through targeted marketing or in some cases, “red carpet” treatment and gratis benefits. I sense that the leaders in the hospitality industry engage in this type of personalized process behavior, too.

We could easily produce a report in most ambulatory healthcare settings which lists our “Top Patients.” It’s not exactly the best name for the report, but it gives us insight to the same concept as retail, i.e., Who are the patients visiting us the most often? Which patients are spending the most money on their healthcare? My theory is, these are our sickest patients and potentially the most financially challenged. Their families feel a heavy burden, too. We should keep a close eye on these patients… treat them differently… be more aware of their appointments and encounters… make life easier for them in terms of their encounters… maybe offer preferred scheduling and parking… maybe proactively reach out to them and their families to manage their experience better… process their claims differently…work with their employers and insurance companies more closely… and proactively target them for financial assistance if needed. Of course, I’m not so sure it would be a good idea to tell these patients that, “Congratulations! You are one of our Top 50 Patients!” The awareness on our part should be subtle and in the background, but patient treatment in the foreground should be noticeably different and more personalized.

I’m not exactly sure what this looks like operationally, but I do think that we should be more aware of and adaptive to these patients and their families, and do something different with their treatment and experience. There might be opportunities for research, too, assuming that these patients represent a significantly different, outlying health experience than other patients.

It’s a step towards Personalized Medicine, but from a process perspective, not from a genomics perspective.

Maybe some organizations are already doing this?

"Doctor, your EHR is killing me."

If you haven't read the March 27 JAMA commentary from Ross Koppel and David Kreda, you should track it down. In summary, they point out very appropriately, that there are patient safety issues associated with the use of EHRs, and that HIT vendors should not be allowed to contractually walk away from their safety obligations in the design and implementation of their products. I agree with the commentary and add that the obligations for patient safety don't end with the vendors; we HIT customers are obligated, too.

There is ample precedence for regulated safety among us--e.g., the Federal 510(k) process for medical devices includes a safety analysis. Laboratory information systems safety is regulated by CLIA. The software systems in the utility and transportation industries are regulated for software safety. Military command and control and information systems are regulated for software safety.

There are several layers of software safety risks associated with today's EHRs, from point-of-care decision support to the back end spaghetti of interfaces that populate a typical EHR. I'm not a fan of Federal overkill on regulations, but you have to admit that HIPAA finally drove our industry towards much better practices in patient data security and privacy protection. Without HIPAA's influence, I bet we'd still be piecemealing HIT information security and privacy. We need the equivalent of HIPAA for HIT’s impact on patient safety. Today's EHRs play a major role in the safe (or not) treatment of patients, every bit as important as medical devices. Now is the time to start planning for this as a culture. We can do it in parallel with the push for an EHR in very office.

With all these concerns in mind, it’s important to remember that the benefits of a properly implemented EHR to patient care still far outweigh the risks to patient safety. Driving a car safely is a complex process and prone to many errors, but we haven’t stopped buying and driving cars. We just keep making the car-driving process safer.

Data Security: Which Matters More?

I'm running a little experiment here to see how people feel about protecting their personal data. Mostly I'm motivated by curiosity, but also by the recent Federal interest in Red Flag events in healthcare. The Federal Trade Commission (FTC) issued a regulation in 2007 to address identity theft. Known as the "Red Flag Rule", it requires “covered accounts” to develop an identity theft prevention program. Here's a one-question survey on the topic.

Click here to take the survey

I'll share the results in a few days.

We Lost a Leader: The Passing of Al Pryor

Let me begin by saying that, in reality, I’m not worthy of honoring Al Pryor. Such honor is bestowed upon his family and friends who knew him much longer and deeper than I did. My fond appreciation and respect for him are all that I have to offer.

Among his countless medical informatics achievements, T. Allan Pryor was one of the "inventors" of Intermountain Healthcare’s HELP electronic health record system, along with Reed Gardner and Homer Warner Sr. They started a discussion 40+ years ago which is now on the lips of our country's President, Congress, and every corporate leader and physician in America.

There will never be another Al Pryor. His personality would sense the vacuum of dullness and mediocrity and fill it in a flash-- with humor, insight, and intellectual provocation. He kept you laughing and he kept you on your toes-- you never knew what might come next... it might be a joke or it might be a brilliant thought, and quite often, they were delivered together. There is a lesson about leadership therein, one could suspect.

In the early and mid-90's, I was working on a computerized nuclear warfare decision support system for the Pentagon when I met Al Pryor and Reed Gardner. They didn't know what I was working on at the time-- I couldn't talk about it-- but in my research, I came across their publications regarding the use of computers in time-compressed and life-critical decision support environments, so we arranged a meeting with them at LDS Hospital in Salt Lake City. The meeting was so fun and they were so engaging, I returned to my boss at TRW and said, "Adios. Get me out of the nuclear warfare business. Healthcare decision support is the *real* frontier." Three years later, I was lucky enough to be working for Al Pryor and Intermountain. He gave me the chance to lead Intermountain’s Enterprise Data Warehouse initiative, which at the time, was a fledgling project with one of Al’s graduate students. We turned the EDW into an impressive success story for Intermountain and the industry, but along the way, the project had some seriously dark periods. Many people tried quite deliberately to undermine and kill it. During one of those more depressing and troubling periods, I sought his counsel. I can still remember sitting in his office when he shared advice with me that reveals his values as well as his frank, pioneering, and admirable style. It’s advice that sticks with me today-- “If what you’re doing is fundamentally right, then stick to it. Why all the worry? You’ll eventually overcome the critics. And always remember: Physicians run the roost in healthcare. They bring home the bacon. As long as you keep them on your side and make them happy, you’re in good shape. Don’t let the bean counters fool you into thinking that they’re in charge.” :-)

By the way, some of the knowledge gleaned from Al and Reed made it back into our country's processes for determining when to "launch on warning" and when not to-- it's all about false positives and false negatives, which, of course, is incredibly critical in the scheme of nuclear weapons command and control. Al and Reed’s influence is buried without reference in the President's "Black Book" and the Emergency Action Procedures of the Joint Chiefs of Staff, Volumes IV and V. Bizarre but very true tale.

You never know who will change your life, in what way, or how far the ripple of your influence will extend, but Al Pryor changed mine and the lives of many, many people for the better.

Personalized Medicine at the Point of Care?

I'm concerned that the speeding bullet of genomic discovery is going to outpace our ability to keep up with the demand for tests and our ability to fold the results and knowledge back into the EHR for consumption at the point of care and the process of delivering care. In fact, we already know enough about the effects of genetics on certain healthcare-related conditions, such as warfarin metabolism, that should be presented at the point of care, but largely are not.

This quest for "personalized medicine" seems like a supply chain of data-- i.e., Are we generating the data content in the machinery of healthcare to enable the production of personalized medicine? In my limited brain, the supply chain of data includes these data types and sources:

• Patient demographic data (Registration, patient reported, etc.)
• Clinical treatment data (Epic, Cerner, pharmacy, claims data, etc.)
• Clinical outcomes data (Epic, Cerner, pathology labs, diagnostic labs, other diagnostics, patient reported outcomes etc.)
• Familial data (Patient reported)
• Biological data (Labs)

Yesterday, at a demonstration of Xenobase at Childrens Memorial Research Center, as I was walking through this mental checklist of supply chain data content and sources, a couple of things struck me: (1) If I wanted my genome analyzed for inherited disease tendencies, I wouldn't know who to ask at Northwestern for that analysis; and (2) I didn't know if our hospital labs were running those tests or not and whether that data was somehow making its way back into our Cerner or Epic EHRs, or our Enterprise Data Warehouse. However, I do know that the Northwestern Core Genetics lab can run the tests... but how does that data make its way into my EHR? I can have commercial organizations like www.23andme.com run a personal DNA analysis... but I wouldn't know what to do with the results if they indicated a genetic risk of disease, nor would I know if I should trust the results, in any case.

It seems to me that we need to do a few things in the near term: (1) Engage EHR vendors in this discussion and ask, "What's your plan for incorporating the knowledge from genetic medicine into your decision support environment?; and (2) Move the collection and discovery of "genetic medicine" from the background of research into the foreground of healthcare operations. I think the term for this now is "translational" medicine. Genetic tests should be offered to those patients who are interested, but those patients should not necessarily be required to participate in a clinical trial in order to have their DNA analyzed for healthcare risks. Commercial ventures like 23andme are gearing-up in a free-market way to democratize the availability of these tests, and the knowledge associated with them.

Some geneticists argue that the emerging commercial genetic ventures are irresponsible and dangerous-- that they are releasing information that's "unsafe" to patients because the knowledge is not fully vetted and patients won't be informed enough to make informed decisions. Every time I hear someone espouse something akin to the general motive of controlling information to protect the consumer from their own ignorance, I can't help but reflect on the same motives for repressing knowledge, literacy, writing, language translation, etc. that come and go through human history, yet always are eventually doomed to failure. Rather than repressing knowledge, we should do everything we can to release the knowledge we have now as quickly as possible, and thus achieve greater knowledge, sooner.