#HCSummit16 final thoughts

Well, only in Lake Wobegon are all things above average all of the time. My #HCSummit16 experience was a bit of a disappointment, to be candid (and it had nothing to do with the Summit content). My long inbound flight delay out of SFO put me at MIA so late that I was running on fumes on Day 1 of the Summit, after only about 4 hours' sleep. The in-your-face asphyxiating heat/humidity combination (90F + 100% humidity, episodic T-storms) didn't help; I'd get out of my rental car and my glasses would immediately fog over. The oppressive heat also meant that the AC at the venue would typically be walk-in freezer cold. I was wishing I'd brought a jacket or sweater.

I was so tired by Wednesday afternoon there was no way I'd stay up late enough to attend John Toussaint's jazz band performance, as I did last year. I got back to my hotel (I was staying offsite) and promptly crashed out. Hated to miss that.

Then there was the limiting liability of attending solo, which meant that I'd not get to see most of the concurrent AM and PM learning sessions. Back when I was with HealthInsight during the REC days we typically had at least four or five people tag-teaming events such as HIMSS so we could compare notes and max out our individual and collective experience.

I'd said at the HCSummit16 outset I'd be particularly interested in "Leadership" presentations, and anything detailing the effective integration of Health IT into Lean initiatives.

Notwithstanding repeated tweets, I got no takers, and there was nothing in the presentations I did attend expressly addressing the HIT-Lean topic. Neither did casual talk with other attendees during lunch and intermissions yield any engagement.

It remains a priority issue of importance for me. It should be obvious just why, given that health care delivery remains an irreducibly high-cognitive-burden, fast-paced endeavor, one where data acquisition and evaluation are critical. BTW, see my May post "Technology, particularly the technology of knowledge, shapes our thought."

apropos of workflow, I'd brought up one aspect of this last year:

Most recently, I again brought this up during my recent HIMSS16 coverage.

Whatever. Continuing missed opportunity here.

The "Leadership" stuff was again fine, both as expressed in the Keynotes and Mark Graban's excellent CEO panel.

Speaking of Keynotes, I was delighted by Dr. Patrick Conway's CMS presentation.

The CMS budget comprises about a quarter of federal spending. Effectively Leaning up cannot but have significantly beneficial effects. We'll see. The federal government suffers from what I call "Policy ADHD" roughly correlated with election cycles, and Lean is not a Gartner Hype Cycle management fad.

THE LEAN DENTIST

I didn't attend Dr. Bahri's session.

They handed out comp copies of his book. Very good.

Introduction
Walking into a dental practice in Jacksonville, FL one would hardly expect to find a learning laboratory for lean practices or a relentless lean pioneer. But that’s exactly what I found when I first visited the offices of Dr. Sami Bahri in 2007. I had already heard about the “lean dentist” from lean thought leaders like Jim Womack and John Shook, and respected lean practitioners like Jerry Bussell from Medtronic. They all said the same thing, “You've got to see this guy … He actually gets it!”

So what does it mean to “get it” when you’re the leader of an organization, whether it’s a dental practice with a dozen employees or a Fortune 500 company? Let’s remember that the “it” we’re talking about is real lean that strives to consistently deliver only value-creating services to the customer. The Lean Enterprise Institute (LEI) has chosen to share Sami Bahri’s story because he has proven that he understands what a lean transformation requires of a leader:

• A deep understanding of how your customers define “value”and a willingness to build your organization around that definition
• Getting your hands dirty in the real work of your organization to understand where the value is flowing … and where it’s not 
• Treating your organization as a system rather than a collection of disconnected operations
• A commitment to changing your own behavior while understanding what it takes to help others change
• A passion for learning—about your customer, your process and all of its problems, and about creative countermeasures based on constant experimentation
• An honest belief in the power of Plan-Do-Check-Act (PDCA) and a commitment to completing the improvement cycle every time
• Becoming the teacher who models lean thinking, participates in lean experiments, and learns/teaches by asking the right questions, rather than providing the right answers
• Humility to admit that knowledge is everywhere in the organization and that every improvement is temporary

Perhaps the most amazing part of this story is that Dr. Bahri is completely self-taught. Since opening his practice in Jacksonville in 1990, he has read virtually everything in the field of organizational improvement, from Deming’s Out of the Crisis, to Womack and Jones’ Lean Thinking, to Csíkszentmihályi’s Flow: The Psychology of Optimal Experience. Even more importantly, he began experimenting with his staff to convert his new knowledge from theory to practice. So in the process of understanding what it means to be lean, he became the teacher for everyone on his staff (including fellow dentists), the scientific observer for his lean business experiments, and the leader of a lean enterprise.

Dr. Bahri has a profound understanding of the essence of lean. He got this understanding in much the same way as the original developers of the Toyota Production System. He pursued it because of an unshakable belief that there had to be a better way and through his own hands-on PDCA experiments.

It’s been my great pleasure to get to know Sami well while bringing Follow the Learner to the market. The major challenge in the project has been to capture the deep understanding of lean that he has developed over his almost 30-year lean learning journey, while also preserving his gift for “keeping it simple.” In the process, he’s defined an equally “simple”—and very challenging—model of leadership. Butthese are the fundamentals, not the basics of lean leadership. If we’ve done our job, the book will help you to look at the fundamentals of your own lean implementation and the vital role that you must play in it as a leader within your organization.

To provide you with additional information about Dr. Bahri’s lean journey we have created a dedicated web page for this book at the LEI web site: lean.org/ftl...

It's a quick, accessible read. I fired up my Dragon and read in the conclusion.

Conclusion
I am including here a handful of lessons I have learned along the way to keep our lean efforts focused. These lessons have worked well for us and I welcome you to use them, but please also improve upon them and create your own.

Improve the process flow before you eliminate waste from individual operations. Start improvements close to the customer and spread the improvements backward toward the beginning of the value stream. Some operations can be totally eliminated, meaning you may never have to work on them.

Run your value–adding operations in a series and the support functions in parallel. While your value–added operations (e.g., crown or filling in our case) are running, your support functions (e.g., writing notes in the chart) can happen in parallel, at the same time. In practice, we try to keep the patient in the office only for the duration needed to perform the value–added treatment.

Start as small as you can when making improvements within your organization. Mistakes will only have a minor impact.

Change is most effective when it grows naturally.  Grows like an embryo, change needs to start small, drawing upon as few resources as possible, before it can spread outward to encompass the entire organization. Because we tend to think only in batch–and–queue terms even when implementing change, which tends to make a small change somewhere, and as soon as we see good results, we try to spread it over the entire organization. I found that policy to generate early resistance that could halt any change efforts.

We need to fight the desire to spread change on a large scale until we have implemented it as deep as necessary in a small area of the organization. In other words, go 1 inch wide and 1 mile deep, not the opposite.

Use small–scale experiments to prove to your coworkers that the changes you are proposing are actually improvements. Providing proof changes minds, establishes trust, and reduces resistance to change.

Shorten the lead time to make your processes more flexible and more responsive, so you can respond faster to market changes. Look for flexibility in your people's attitude, the flexibility to learn and to help whenever and wherever they are needed. This is the best way to constantly increase capacity in your organization.
Put the decision-makers together rather than in separate locations. To facilitate one–piece flow, we like people who need to make decisions and who owned different pieces of the puzzle to be located in one space around the patient.

Communication and decision–making will improve dramatically. For example, our treatment plan coordinator, Candace had an office that she kept even after she became flow manager. One day she was sitting across the table, discussing the schedule with me. I was holding a color printed schedule that showed me more details than the black and white printed schedule that she held. Because of that difference, she could not understand everything I described about the schedule. Frustrated, she came to sit next to me. As soon as we looked at the same paper, we had no more communication problems.

"If it is so difficult to communicate while across the table from each other," she reflected, "it must be even more difficult for the assistance to communicate with me when I am in my office and they are in the treatment room."

She decided to abandon the office that she had used for over 10 years. The next morning, she moved to a desk right behind the hygienists and dentists. From her new location she could hear the hissing of the cleaning machine, and when it stopped; she did not need anybody to tell her that the cleaning was finished. If anyone needed help with an insurance or scheduling question, they did not need to call her anymore because she was right there and could hear the discussion.

Most importantly, learn. However you can, learn. Even when I was teaching dentistry, I have found that learning was more fun than teaching. When I began learning lean management, I explored a new knowledge first with an interested individual and then with everyone on the staff. Today, I'm always adding to my network of fellow leaned learners from around the world, so that I can learn more and more creative lean applications. My only plan is to keep learning. My wish is that every leader becomes a lifelong lean the learner and teacher.

But start implementing lean today. Do not wait until you have learned "all about lien," including the leadership principles I've written about here. In the end, practices the only thing that will enable you to find your way by learning your own way. These personal lessons will determine the kind of leader that you will become. (Pages 87 – 90)

I went to Amazon to see whether it was offered there. No, but I did find this.

Okeee dokeee now... LOL.

"The Lean Dentist" is available here.

There is no shortage of worthy QI books to study. Four of my cut-to-the-chase favs:

Count me Old School Deming, for one thing.
CODA

I have a couple of technical recommendations. First, the lighting. Of all the conferences I attend every year, the Lean Healthcare Summit is by far the weakest in terms of presentation venue stage lighting. It's like one continuous sleepy Happy Hour ambience. Two sparse light trees at the back of the ballroom, outfitted with about four or five poorly aimed white spots each (the left side podium was literally in the dark), no backlighting, no floods.

The Health 2.0 conferences are the best in this regard. Pro A/V. We should learn from them.

Second, I lost track of the overloaded, impossible-to-assimilate slides, e.g.,

This syndrome is by no means unique to the Summit. We've all been to myriad presentations wherein the speakers drone on ad nauseum reading through their text-heavy slides (and, to be fair, I have not always uniformly walked my own talk -- pdf). Some of the Summit16 presentations were manic, with speakers plowing intensely through too much visual material.

I already know how to read.

Again, Health 2.0 conference presentations are -- well -- leaner, and consequently more effective in terms of information delivery. Attend. See for yourself. I'll be there again this fall.

One of John Shook's closing Keynote slides.

OK, I also recommend, to the extent practicable, application of the principles embodied here:

Performance in three acts
The Presentation Secrets of Steve Jobs is structured like one of Jobs’s favorite presentation metaphors: a three-act play. In fact, a Steve Jobs presentation is very much like a dramatic play—a finely crafted and well-rehearsed performance that informs, entertains, and inspires. When Jobs introduced the video iPod on October 12, 2005, he chose the California Theatre in San Jose as his stage. It was an appropriate setting as Steve divided the product introductions into three acts, “like every classic story.” In act 1, he introduced the new iMac G5 with built-in video camera. Act 2 kicked off the release of the fifth-generation iPod, which played video content for the first time. In act 3, he talked about iTunes 6, with the news that ABC would make television shows available for iTunes and the new video iPod. Jobs even introduced jazz legend Wynton Marsalis as an encore.

In keeping with Jobs’s metaphor of a presentation as a classic story, The Presentation Secrets of Steve Jobs is divided into three acts:

• Act 1: Create the Story. The seven chapters—or scenes—in this section will give you practical tools to craft an exciting story behind your brand. A strong story will give you the confidence and ability to win over your audience. 
• Act 2: Deliver the Experience. In these six scenes, you will learn practical tips to turn your presentations into visually appealing and “must-have” experiences.
• Act 3: Refine and Rehearse. The remaining five scenes will tackle topics such as body language, verbal delivery, and making “scripted” presentations sound natural and conversational. Even your choice of wardrobe will be addressed. You will learn why mock turtlenecks, jeans, and running shoes are suitable for Jobs but could mean the end of your career.

Short intermissions divide the acts. These intermissions contain nuggets of great information culled from the latest findings in cognitive research and presentation design. These findings will help you take your presentations to an entirely new level.

Gallo, Carmine (2009-09-11). The Presentation Secrets of Steve Jobs: How to Be Insanely Great in Front of Any Audience (Location 178). McGraw-Hill. Kindle Edition.

ACT I
Create the Story

Creating the story, the plot, is the first step to selling your ideas with power, persuasion, and charisma. Succeeding at this step separates mediocre communicators from extraordinary ones. Most people fail to think through their story. Effective communicators plan effectively, develop compelling messages and headlines, make it easy for their listeners to follow the narrative, and introduce a common enemy to build the drama. The seven chapters—or scenes—in Act 1 will help set the foundation for presentation success. Each scene will be followed by a short summary of specific and tangible lessons you can easily apply today. Let’s review the scenes here:

• SCENE 1: “Plan in Analog.” In this chapter, you will learn how truly great presenters such as Steve Jobs visualize, plan, and create ideas well before they open the presentation software.
• SCENE 2: “Answer the One Question That Matters Most.” Your listeners are asking themselves one question and one question only: “Why should I care?” Disregard this question, and your audience will dismiss you.
• SCENE 3: “Develop a Messianic Sense of Purpose.” Steve Jobs was worth more than $100 million by the time he was twenty-five, and it didn’t matter to him. Understanding this one fact will help you unlock the secret behind Jobs’s extraordinary charisma.
• SCENE 4: “Create Twitter-Like Headlines.” The social networking site has changed the way we communicate. Developing headlines that fit into 140-character sentences will help you sell your ideas more persuasively.
• SCENE 5: “Draw a Road Map.” Steve Jobs makes his argument easy to follow by adopting one of the most powerful principles of persuasion: the rule of three.
• SCENE 6: “Introduce the Antagonist.” Every great Steve Jobs presentation introduces a common villain that the audience can turn against. Once he introduces an enemy, the stage is set for the next scene.
• SCENE 7: “Reveal the Conquering Hero.” Every great Steve Jobs presentation introduces a hero the audience can rally around. The hero offers a better way of doing something, breaks from the status quo, and inspires people to embrace innovation (ibid, pp. 1-2)

ACT 2
Deliver the Experience

Steve Jobs does not deliver a presentation. He offers an experience. Imagine visiting New York City to watch an award-winning play on Broadway. You would expect to see multiple characters, elaborate stage props, stunning visual backgrounds, and one glorious moment when you knew that the money you spent on the ticket was well worth it. In Act 2, you will discover that a Steve Jobs presentation contains each of these elements, helping Jobs create a strong emotional connection between himself and his audience.

Just as in Act 1, each scene will be followed by a summary of specific and tangible lessons you can easily apply today. Following is a short description of each scene in this act:

• SCENE 8: “Channel Their Inner Zen.” Simplification is a key feature in all of Apple’s designs. Jobs applies the same approach to the way he creates his slides. Every slide is simple, visual, and engaging.
• SCENE 9: “Dress Up Your Numbers.” Data is meaningless without context. Jobs makes statistics come alive and, most important, discusses numbers in a context that is relevant to his audience.
• SCENE 10: “Use ‘Amazingly Zippy’ Words.” The “mere mortals” who experience an “unbelievable” Steve Jobs presentation find it “cool,” “amazing,” and “awesome.” These are just some of the zippy words Jobs uses frequently. Find out why Jobs uses the words he does and why they work.
• SCENE 11: “Share the Stage.” Apple is a rare company whose fortunes are closely tied to its cofounder. Despite the fact that Apple has a deep bench of brilliant leaders, many observers say Apple is a one-man show. Perhaps. But Jobs treats presentations as a symphony.
• SCENE 12: “Stage Your Presentation with Props.” Demonstrations play a very important supporting role in every Jobs presentation. Learn how to deliver demos with pizzazz.
• SCENE 13: “Reveal a ‘Holy Shit’ Moment.” From his earliest presentations, Jobs had a flair for the dramatic. Just when you think you have seen all there is to see or heard all there is to hear, Jobs springs a surprise. The moment is planned and scripted for maximum impact. (ibid, pp. 85-86)

ACT 3
Refine and Rehearse

 So far, we’ve learned how Steve Jobs plans his presentations. We’ve talked about how he supports the narrative through his words and slides. We’ve discussed how he assembles the cast, creates demos, and wows his audience with one dynamic moment that leaves everyone in awe. Finally, you’ll learn how Jobs refines and rehearses his presentation to make an emotional connection with the audience. This final step is essential for anyone who wants to talk, walk, and look like a leader. Let’s preview the scenes in this act:

• SCENE 14: “Master Stage Presence.” How you say something is as important as what you say, if not more so. Body language and verbal delivery account for 63 to 90 percent of the impression you leave on your audience, depending upon which study you cite. Steve Jobs’s delivery matches the power of his words.
• SCENE 15: “Make It Look Effortless.” Few speakers rehearse more than Steve Jobs. His preparation time is legendary among the people closest to him. Researchers have discovered exactly how many hours of practice it takes to achieve mastery in a given skill. In this chapter, you’ll learn how Jobs confirms these theories and how you can apply them to improve your own presentation skills.
• SCENE 16: “Wear the Appropriate Costume.” Jobs has the easiest wardrobe selection in the world: it’s the same for all of his presentations. His attire is so well known that even “Saturday Night Live” and “30 Rock” poked some good-natured fun at him. Learn why it’s OK for Jobs to dress the way he does but it could mean career suicide if you follow his lead.
• SCENE 17: “Toss the Script.” Jobs talks to the audience, not to his slides. He makes strong eye contact because he has practiced effectively. This chapter will teach you how to practice the right way so you, too, can toss the script.
• SCENE 18: “Have Fun.” Despite the extensive preparation that goes into a Steve Jobs presentation, things don’t always go according to plan. Nothing rattles Jobs, because his first goal is to have fun! (ibid, pp. 165-166)

Again, "to the extent practicable." Technical content presentations differ materially from short marketing content delivery. But, are we jamming too much in?

I also study the delivery approach contained in TED Talks. e.g.,

____________

More to come...

#IHI25Forum Updates

Well, I had a choice to make. Go back to my hotel and blog my take on the day, or go to the IHI 25th anniversary pool party. What would you have done?

Asked and Answered.

Consequently, blog updates are a bit delayed. More great stuff to attend. Started my Wednesday off with this:

Dr. Nancy Snyderman and her former cancer patient the incredible Lindsay Beck. This keynote interview was beyond worth the price of attending. I'm really a bit stunned at this story. I told Dr. Synderman afterward, "OK, I gotta go lie down now. I'm completely drained."

Wow.

A recent graduate of Wharton’s Executive MBA Program based in San Francisco, Lindsay Beck had been diagnosed with a rare tongue cancer when she was 22. When the malignancy recurred and she inadvertently discovered her chemotherapy could leave her sterile, she launched into an advocacy campaign that changed the face of American medicine. Through her charity, Fertile Hope (now part of the LIVESTRONG Foundation), she co-wrote the oncology treatment guidelines to protect the reproductive rights of young patients like herself. She then lobbied among the massive health insurers and countless self-insured employers to help fund the care...

From the IHI program speaker's bio:

Available on Amazon

__

FRIDAY THE 13TH UPDATE

Well, [bleep], after an exhausting 15 hour trip home, replete with an anxious medical emergency diversion landing in Raleigh-Durham that caused me to miss my BOS-SFO connecting flight,

I've just spent two hours updating the blog, and had a total lockup in the blogger.com editor in the Firefox browser platform while uploading a photo, causing me to lose everything I just added. Had to do a hard-reboot, following which there was no cache recovery. Starting over. Grrr.rr.r...

TAKE 2: 
"NO MORE HEROES"

Left the Snyderman-Beck Keynote after they finished and went to Dr. Toussaint's presentation.

E5: Beyond the CEO: Sustaining ThedaCare's culture

When the CEO retires or leaves, an organization changes. The culture of improvement can be destroyed overnight by the new leader. Lasting change requires that organizations hardwire improvement thinking into succession candidates. It also requires board commitment to choosing internal candidates with the characteristics required to accelerate the improvement journey. In this workshop, ThedaCare’s former CEO, John Toussaint, and present CEO, Dean Gruner, will describe the process of sustaining an improvement culture that outlives the tenure of any one CEO.

OBJECTIVES

• Identify the standard work for succession planning that senior management and boards use to choose leaders with the right behavioral and management competencies to lead in an improvement culture 
• Implement a management system that hardwires improvement skills into all succession candidates

PRESENTERS
Dean Gruner
President & CEO, ThedaCare
John Toussaint, CEO, ThedaCare Center for Healthcare Value

I have long cited and characterized John Toussaint as "one of my heroes." (See here, my 2nd REC blog post in 2010, or just search "Toussaint" in my blog search cell at the upper left to see the many times I've referred to him in buttressing my arguments.)

So, it was interesting that he said that their upcoming book release will carry the title of "No More Heroes."

Below, Dr. Toussaint's successor as ThedaCare CEO, Dr. Dean Gruner.

Very enlightening presentation.

Dr. Gruner is an equally delightful man, and is an OLE to boot! I am a proud St. Olaf Grandparent. Great school. He gave me a big smiling High Five when I told him my grandson was a sophomore there.

apropos of CEO succession: from the conclusion of Dr. Toussaint's wonderful book "On the Mend":

In the middle of 2006, John came to a decision. After six years leading the organization and five years fighting to get lean adopted across ThedaCare hospitals, clinics, and corporate offices, John knew that he was, metaphorically at least, stuck all over with the arrows of long battles with physician groups and staff.

During those six years, ThedaCare had sold off its HMO health plan, lost all of the orthopedic surgeons in one hospital, and seen morale plummet. On the other hand, quality of care was increasing fast in 2006 and attracting notice. Morale was starting to trend upward, but John believed his personal stock had suffered in the early battles.

Also, John had a very good idea of what it took to be a transformational lean leader and what it took to be a steady-state lean manager, moving the organization incrementally but relentlessly ahead. He could recite a list of necessary attributes of a lean manager off the top of his head and he knew those qualities did not describe him.

John was a great communicator and a better instigator. He was good at lighting fires, but he was not the kind of calm and steady facilitator needed to keep the fire burning in the right direction. And he was already looking at a larger playing field, wanting to spread the lean healthcare revolution beyond ThedaCare. It was nearing time to go. 

Succession planning, which had always been high on John’s agenda, now moved to the top. Preparing for a smooth transition is vital work for any business, but it is critical for lean organizations since so few experienced leaders know lean. At ThedaCare, we spent years building this nascent lean organization and knew that an autocratic outsider with a different agenda could destroy it in minutes. It was still a stretch for some people to take responsibility for their own work environment and it would have been a relief for them to fall back into the old ways, waiting for orders and keeping their heads down. But John was thinking about those at ThedaCare who had eagerly adopted lean, put themselves on the line, and applied their talents toward making real change. This group—growing in number—believed in the power of lean and John could not let them down.

ThedaCare needed to find a lean CEO—someone who embraced the principles and would use them to formulate ThedaCare’s strategy. At the time, there were no lean healthcare systems to poach for leadership, but looking at his senior executive team, John counted a number of individuals with enthusiasm and fresh energy. He quietly asked who among these wanted to be CEO and a few hands went up.

This was the beginning of a two-year PDSA cycle focused on succession in which John studied the issue of lean leadership, created individualized training programs, and personally mentored the CEO candidates. He expanded their portfolios and watched them carefully on gemba walks. Due to confidentiality and personnel concerns, we will be vague about the candidates. Still, the experience was instructive and should underline the importance of leadership transitions in a lean environment.

Ultimately, John’s goal was to present at least two internal CEO candidates to the board of directors who were well qualified, hungry for the job, and committed to lean. If he failed, his legacy would probably be an almost-lean organization, where the idea of continuous improvement had come briefly to life but then sputtered and died, leaving people reluctant to put energy into the next initiative. If he succeeded, the board would have a wealth of good choices and a leader prepared to advance the lean initiative into its second generation.

Toussaint, John; Gerard, Roger (2010-06-06). On the Mend: Revolutionizing Healthcare to Save Lives and Transform the Industry (Kindle Locations 1919-1928). Lean Enterprise Institute, Inc.. Kindle Edition. 

You will thoroughly enjoy this book if you've not already read it.

I simply must go visit the ThedaCare organizations soon. Hmmm... maybe in the dead of winter, so I can make another side visit to my sister's in Marquettte, MI, to celebrate my 68th birthday in February and ski their little hill. Brrr.r.r...

FINAL KEYNOTE: DR. DON BERWICK.

One inspiring man, I have to say. Check out the YouTube of his closing Keynote (Dr. Berwick is introduced at 0:59:33).

"Who's your Caleb?"

WELCOME TO THE DANCE

And so, #IHI25Forum comes to an exuberant, kinetic close, with well-deserved Props to the Blue Shirt volunteers contingent. They were fabulous.

"Well, I sat down in the very first row,

Expecting to see what was advertised,

And, the very next thing I know

The picture had become my eyes..."

Sons of Champlin, "Welcome to the Dance"

Yeah. I wrote a song about "The Dance" a third of a century ago. From my Pinterest site:

I would do well to take my own advice more consistently. Easy to lose sight of The Dance amid the daily din of contention and detail.
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Much more to come...

G-A-T-C, meet SCOTUS

Whatever becomes of the REC initiative, the Really Big Picture Aim of health IT is obviously that of the interoperable provision of comprehensive and useful on-demand clinical information, both as it relates to the individual patient being seen by her physician, and, by extension, accruing data relevant to objectively improving population health. It is also argued that the foregoing will also serve to reduce per capita health care expenses (the 3rd leg of the much ballyhoo'ed "Triple Aim" stool).

A core component of the most finely-grained individual "health" data is that of one's DNA, and it is proffered that the next generations of EHRs be able to provided such data to clinicians. The incipient field of science known as "Personalized Medicine" is all abuzz with positive anticipation (I've posted on this topic before).

Above: from an FDA web page

Perhaps. But, given that truly "personalized" therapeutics will necessarily have a market potential of precisely one, cost will consequently be a major factor, will it not?

Among other things, we ought keep an eye on this:

Cert was granted November 30th, 2012:

QUESTIONS PRESENTED

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, including any naturally occurring mutations of those genes, on the theory that simply by removing (“isolating”) the genes from the body, they have invented something patentable. Petitioners are primarily medical professionals who routinely use standard genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:

1. Are human genes patentable?

2. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?...

STATEMENT OF THE CASE

1. This case challenges the patenting of human genes. More specifically, it challenges patents awarded to Myriad Genetics on two genes, known as BRCA1 and BRCA2 because mutations of those genes correlate with an increased risk of hereditary breast and ovarian cancer. App. at 19a. Myriad claims exclusive control over the genes once they have been “isolated” – that is, removed from the body and other cellular material. Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining thousands of naturally-occurring human genes and to prevent patients’ access to their own genetic information. The practical consequence of these patents is that Myriad has the authority to stop standard clinical testing of and research on its genes. For those at risk of hereditary cancer, the effect is to prevent second opinions and to block access to alternative and potentially more comprehensive tests and lower cost options...

At once nominally narrow but, still, with inevitably broad import.

As noted yesterday on Health Affairs:

A Cure For Patent Pathology? The Supreme Court Reviews The Patentability Of Human Genes
by John Golden and William Sage

“Are human genes patentable?”  On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics.  Of course, the petitioners, including health care providers, professional associations, and patients, worded the question to favor the answer they want: “No, human genes are not patentable.”  For Myriad Genetics, the patent owner who would like its patent rights upheld, the question is better phrased as whether one can patent “isolated molecules of deoxyribonucleic acid that were identified and defined by human inventors.”

The practical stakes in the Court’s decision, which should come in the first half of 2013, are enormous.  The U.S. Patent and Trademark Office (USPTO) has issued tens of thousands of patents on genetic sequences over the past few decades, and the U.S. Court of Appeals for the Federal Circuit, the appellate court entrusted with hearing virtually all U.S. patent appeals, has never declared such sequences to be non-patentable subject matter.  For more than a century, patents have issued on isolated versions of naturally occurring substances other than DNA.

Many believe that gene patents are crucial to the modern biotechnology industry.  On the other hand, many researchers and clinicians feel that gene patents, particularly human gene patents, are commonly unnecessary to spur innovation and in fact interfere significantly with scientific and technological progress, whether by slowing or diverting research, impeding the provision of diagnostic tests, or generally increasing costs for clinical and scientific work.

The patents at issue in Myriad make such concerns particularly poignant.  These patents relate to BRCA1 and BRCA2, genes associated with a predisposition to breast cancer.  The obvious public interest in ready access to cancer diagnosis helps account for the fact that petitioners’ lead lawyers are not the normal high-priced advocates for a private company accused of patent infringement.  Instead, those lawyers work for the American Civil Liberties Union Foundation, an organization more commonly associated with battles for civil rights than rights in technological innovations...

Indeed. Just what I needed; another 475 pages of legal stuff to review. Though, I have to say that, in general, appellate level and SCOTUS writs, briefs, and decisions are far better reading than most legislative bills. Probably has to do with the function of the court: cleaning up the bloated, internally inconsistent, and vague messes the politicians foist upon us (yeah, I know, it's more complex than that).

Much to discuss.

BTW: I've posted before on the topic of health related "intellectual property."

P.M. UPDATE

Just got back from helping man our HealtHIE Nevada booth at this event.

www.meridianmps.com

I'd not really heard of this company before. Based here in Vegas. A subscription model physician "concierge" service sort of thing, I take it. Still digging to ID the Principals (no substantive "About Us" link on the website). The CEO is a very personable fellow by the name of Charles Tramont -- apropos, see also Ferus Creative).

They produce a pretty snappy full-bleed four-color mag, I have to say (registration required for a comp issue; worth it). Charles told me it's going print media release come January. Nice. It has that KNPR "Desert Companion" look & feel.

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DECEMBER 10th, MONDAY MORNING UPDATE

No HIPAA Omnibus Final Rule yet in the Federal Register. Tick, tick, tick...

iPad Lean App for healthcare.

Description
This app is designed for anyone working in healthcare who wants to improve the work environment and the patient experience. Associates, Managers and Executives with either some or no experience with Lean will benefit from this app. If you are concerned about addressing current or future challenges in healthcare, this is a great introduction to Lean thinking that is packed with practical ways to introduce Lean in your hospital, clinic or practice.

The Lean Sensei in this app will help guide you on your Lean journey through:

• Audio, video and print content covering the history of Lean and how the Lean business model is beginning to influence the delivery of care

• Practical case studies and examples from a Surgical Suite, Emergency Department, Physician Practice, and a Hospital Laboratory

• An interactive Assessment and Improvement Guide that will help you communicate how Lean can impact the continuum of care financially and operationally

The app is narrated by Lean Sensei, Todd Sperl, an enthusiastic, creative speaker and process improvement expert who looks beyond today’s problems to find tomorrow’s solutions. As Owner and Managing Partner of Lean Fox Solutions, Todd’s vision is to improve the patient care experience from one health care touch point to the next. Along with facilitating numerous projects across the continuum of care (Physician Practices, Specialty Clinics, Hospitals and more), Todd lectures, blogs, and writes about Lean Healthcare.

Over the years healthcare has gone through an evolution of process improvement methodologies such as Quality Circles and CQI. Lean is a new way of thinking that encourages you to be creative, to question everything, to look beyond traditional metrics. To continuously assess what is over-valued and under-valued at your organization. Lean and it’s problem solving counterpart, Six Sigma, offer the healthcare community the opportunity to obtain long term, sustainable results. Look for more apps in our “Lean Sensei for Healthcare” series.

Requirements: Compatible with iPad. Requires iOS 5.0 or later.

I would buy this in a heartbeat. Mine is an older iPad, though. My affinity for the Lean approach is well established on the REC blog.
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ONC INFOGRAPHIC

Nicely done, IMO.

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FROM FierceHealthIT and Honeywell

mHealth's Impact on the Future of Meaningful Use
Now available for on-demand viewing. Duration: 1 hour 

Mobile health tools are rapidly being deployed throughout the healthcare industry, enabling providers to do their jobs faster, more efficiently, and essentially on-demand. Still, the role such tools play in helping providers to meet the federal government’s ever expanding Meaningful Use guidelines for the implementation of electronic health records remains unclear.

Mobile technologies and mHealth have huge potential to help providers meet Meaningful Use requirements. They offer clinicians fast and easy access to electronic health records data and can help engage patients in their own health data--both of which are requirements under the final Stage 2 rule and will continue to increase in importance in future stages...

Registration required, but otherwise free.

apropos of the topic, see this from SearchHealthIT:

Ed Burns, Dec 10th, 2012, eburns@techtarget.com

Mobile health tools, both consumer-facing and ones used by physicians, are contributing to the creation of more data related to patients' health than ever before. But this raises the question of who owns that data, and what kind of rights different parties have to access information. Attendees at the mHealth Summit 2012 had very different ideas about health data ownership.

The Health Insurance Portability and Accountability Act (HIPAA) and meaningful use rules state patients have a right to access their records. While physicians may hold the data, they cannot deny patients who ask to see it.

In a town hall session at the summit, members of the Office of the National Coordinator for Health IT (ONC) discussed data ownership issues related to the agency's Blue Button initiatives. The consumer engagement members of the office are encouraging more data holders to implement Blue Button functionality, which would allow patients to download their medical data.

According to Lygeia Ricciardi, acting director of the Office of Consumer eHealth at the ONC, once patients, providers and payers can all easily download medical records, the question of data ownership becomes less important. Rather than thinking about who owns the data, people should think about who has a right to download a copy.

"I'm not sure 'own' is quite the right for it in a digital world," Ricciardi said...

"Data ownership?"

FISCAL CLIFF UPDATE

Props to cousin Jojo for sending me that.

We're three weeks out from the end of the year, and we still don't know what funding mechanisms will be in place for 2013 across the breadth of federal programs and obligations?

Two words: Political Malpractice.
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#ONC2012 is alive and tweeting

 Erick is our REC Manager. Great guy.

UPDATE: 
WELL, THIS ISN'T EXACTLY CONVENIENT TIMING

Americans living longer, but not healthier

By Peter Rudegeair, Reuters

Americans have longer, but not necessarily healthier, lives due to high rates of preventable chronic disease, according to an annual report on the nation's health released on Tuesday.

Gains in life expectancy contrast with Americans' unhealthy behaviors, which have led to a 28 percent adult obesity rate, a diabetes rate of nearly 10 percent and a high blood pressure rate of more than 30 percent, according to United Health Foundation's 2012 America's Health Rankings.

All three conditions are considered risk factors for cardiovascular disease.

Since 1990, premature deaths have declined by 18 percent, cardiovascular deaths have fallen 35 percent, and cancer deaths have slipped by 8 percent, the report said.

Americans' life expectancy was 78.5 years in 2009, 1.7 years above the level in 2000, the report said.

"As a nation, we've made extraordinary gains in longevity over the past decades, but as individuals we are regressing in our health," said Dr. Reed Tuckson, a medical adviser at the United Health Foundation and chief of medical affairs at the UnitedHealth Group...

So, is Health IT gonna help improve things? We have to "Bend the Cost Curve," recall?

I say "yes." But, of course, that could be seen as self-serving.
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HANDWRITING, MEET WALL?

ONC 2012 Day 3 Session: "Grant Closeout process.

Purpose: Present how tips, useful hints and an overall walkthrough of the grant closeout process for Grantees as well as Project Officers.

1. Explain the grant closeout process through the dissection of the Grants Management Memo and Grants Management Advisory on the process.
2. Discuss forms and requirements due to ONC through the closeout process.
3. Explain the process for filing for a no-cost extension for Grantees who elect to file for one.

Date and Time: 8:30 AM - 10:00 AM

WED DEC 12th:
ONC 2012 LIVE WEBCAST

 LINK here. I'm watching for a bit before heading to the office. There are some bandwidth / buffering issues.

7:26 a.m. PDT, Dr. Mostashari addressing ePHI privacy and security.

Have a seat, have a seat. Hi, everybody. So we're going to talk about one of the most important and critical issues for the success of the move towards using information and the power of data to improve health care, and that is making sure that we keep the health information private and secure.

I want to start off by acknowledging that that's one of the core expectations that patients have of their providers. That as they use their health information to take care of them, to share it responsibly, that they keep it private and secure.

This is going to take an all hands on deck approach. The responsibility clearly involves health care providers, there's also a role, an important role, for patients, protection of their own personal health information. There's more that vendors could do. Vendors of the IT systems, to make sure that their products don't introduce any vulnerabilities as we move towards electronic patient information, that they provide the tools to providers to keep their information private and secure, to comply with the HIPAA requirements.

Whether it's around authentication, whether it's around encryption, whether it's around audit logs, our regional extension centers, one of the most important things I believe that we've done is to work with those small practices. To not just make them aware of the requirements and meaningful use that a security assessment be done and that risks be assessed and mitigated, but to actually make that meaningful. We've work with national institute and standards and technology to create tools to figure create the security of those systems and our most important partner and our good friends and colleagues at the Office of Civil rights. And if there's anybody who can deliver the message that health care needs a little bit of a wakeup call, it's Leon Rodriguez. Leon. (Applause.)...

LEON!

Thanks Farzad. So let me start, and Farzad did what he was supposed to do, he left me the clicker.

First of all I want to let everybody know that we carefully analyzed all of the confetti, it is free of any protected health information, so thank you. Whoever.

So it's a -- I had a root canal yesterday. And I feel fine, and I'm very pleased to be here. But it underscored that my experience as a patient has really been transformed by my role as the director for the office for civil rights. And some of you are from Washington, many of you are from elsewhere, but here in Washington, just about the first thing that anybody asks you is what do you do. What do you do for a living.

And so when you go to a health care provider as the lead HIPAA Enforcer for the country, it's always a touchy moment to decide what you're going to say. So for example, when I went to my opt moltion, I was frank with her. I said well, I'm the lead of HIPAA en fors ment. You mean for mayor, no for the United States. For the United States, really? But she shared with me that one of the challenges for health care providers is, well, not surprisingly, mobile devices.

Because patients want to text their doctors, they want to call their doctors on their cell phones, and the security needs have not caught up to the patients' demands to communicate with their doctors in this way.

On the other hand, yesterday when I went for a root canal and I knew that somebody was going to be drilling around my mouth, I simply said that I was an attorney. And I did not -- I did not elaborate. On what my role was.

But all of this points to the two basic roles that we play in the office for civil rights. First, as a 100 percent right improbably first and foremost a patient advocate. And as among other things from the personal experience of finding that so far we are not coordinating care in the way that particularly fits patients needs. Often family members with of varying levels of sophistication varying levels of education varying levels of economic viability are the wounds who find themselves coordinating their family member's care.

And we need to get to a better place.

And so the work that you're doing holds out that promise for America's patients. And my role, my office's role as I've described it before, is very much like the role of the Securities and Exchange Commission for the stock market.

People trust the stock market because they know that there is a watchdog, because they know that there are a set of rules of the road that in most instances ensure the integrity of what goes on in the stock market. So as you're lot on this safety role on which you've embarked it's important that patients have trust in the work that you're doing, and we are looking to be your partner in that role.

Now, high tech has led to a transformation in the way that we enforce the health care privacy laws. Until high tech came along most of our work was what I would call reactive. A patient complaint. A patient said somebody disclosed my information to my ex-husband. I heard somebody gossiping in the waiting room about my health information.

I saw my health information in a dumpster outside my doctor's waiting office.

High tech changed it. High tech changed it because it created a critical mechanism to look behind what the patient sees, to look at the overall picture of what we are doing to make sure that patients' health information is confidential and secure. And so we're doing this in three ways that I'm going to elaborate on in the coming moments. One is to reach notification, in other words requiring health care providers who have had some improper disclosure of health information to report that to their patients, to report it to the office for civil rights, and in certain cases to report it to the media.

We're doing it through audit. In other words Randomly selecting certain entities. And for high clients for privacy of clients, and we're doing it through the oh use of the far more powerful enforcement tools that the high tech statute gave us that we didn't have before.

So let's talk a little bit about breach notification to begin with.

First of all we've been doing this since about 2009, we've received about 500 reports. Significantly for today's discussion, in excess -- nearly 4 million of those individuals affected by theft of laptops or other electronic devices were for mobile devices. So critical for the discussion that we're going to be having today.

Also important to understand as you talk to people about electronic health information, it's not the technology that's failing. It's people that are failing. Okay?

So if you look at the top types of breaches, we're talking about theft, we're talking about unauthorized access and disclosure, we are talking about loss. In other words, things that people either choose to do or they do by neglect.

And so that means that it is not only about building better and stronger technology, but making sure that the people who have protected health information understand and live by the rules of the road, to make sure that that information is safe.

These two charts which are in your materials will give you a good sense of how these issues break down. Significantly, about a quarter of the breaches are actually paper records.

A quarter of the breaches are paper records. Meaning that they are not -- not as completely from the health electronic environment as some would have you believe. And here are some examples of some of the more serious breaches.

So talking now about audits. So the high tech -- high tech statute gave us the authority to conduct audits. This year we are in the middle of a pilot audit that's covering 115 entities. There is a wide variety of entities involved, from small doctors and dentists' offices all the way up to large health care clearinghouses, health plans, large health systems.

And we have made a number -- learned a number of interesting things from this first round of audit activity.

First of all, when we talk about privacy, there is no single type of deficiency that stands out. It runs the gambit.

And so any given provider will have sort of a different menu and range of deficiencies than any other provider.

On the other hand, when we talk about security, and I'm going to forward it over to those issues, we do see particular issues bubbling to the top, and this is actually the first 20, we've now done 115, and so I've learned some interesting additional things.

Certainly, a big issue is monitoring of activity. Okay, looking at what disclosures and uses are being made, and reviewing, at least in some sort of periodic way, what's happening with the health information that's being used as an entity. But probably the single thing that bubbles to the top and you're going to find this interesting when we talk about our enforcement, is risk analysis. The very first thing that you need to do when you're setting up a medical records system from a compliance standpoint, and the thing that we found the greatest -- where we found the most consistent deficiencies, was in the area of risk analysis. In other words, looking at your entire bills process, looking at your entire technology setup, and assessing where the vulnerabilities are, assessing what your resources are to address those vulnerabilities, and then taking the steps to have those vulnerabilities addressed.

And it's not only -- not only the completeness of that risk analysis at any single point in time, but it's also the fact that this is an ongoing exercise. What the HIPAA regulations, what the high tech regulations expect, is that on a periodic basis, a year for example is a good rule of thumb for most types of entities, you are reexamining where you are, you are looking at how you've changed your business process, you're looking at what technology you've added to your business. In order to assess what new steps to ensure the privacy and security of those items need to be taken.

The other issue we saw in a number of cases were issues with policies and procedures. And my favorite one were folks who actually printed policies and procedures off the internet on the day they got the letter from our auditors. And it actually showed the date line from the internet as being when the policies and procedures were issued.

But what's really critical about this is although we encourage encryption, although encryption is clearly, for example, for security purposes, the preferred way to secure health care information, we are really far more concerned about the process. We're really far more concerned about that road map that the HIPAA and high tech rules give you as to what you need to do to assess risk and then to avoid risk. So we're talking about risk analysis, we're talking about training and education of staff, we're talking about disciplinary policies that are actually applied with respect to employees who breach information. We're talking about incident response. When you have a breach, whether it's one that's reportable to OCR or not, that you take steps to analyze that breach, to understand what vulnerabilities led to that breach occurring.

Because as we begin to talk about enforcement, and ume see that enforcement is getting tougher, and tougher as time goes on, what we're looking at less and less is what brought you through the door, what brought you to our attention in the first place. Instead, what we're looking at what was the weakness in your business process that caused a particular issue to occur. That's what we are looking at.

And so you'll see how our -- the various deficiencies that we find in our enforcement cases track the kinds of things that we're finding in the audit process, track the kinds of things that we're learning from our breach cases.

So we are talking about -- we are talking about failure to conduct the risk analysis, we are talking about absence of training, we are talking about failure to have adequate policies and procedures.

We're talking about all those common sense things that we're seeing in audit, that we're seeing in the breach environment.

So one of the lessons of this is that we will be continuing our audit program. And one of the ways that that is funded is in fact from these very recoveries.

So one of the authorities that the hi tech statute provides is to use those recoveries in these cases and to put it right back into enforcement. So that will create our ability no matter what the budget is to do these kinds of cases.

Now, you should take a close look not only at the specific deficiencies that we found, but also at the range of entities that were affected. So uch Phoenix cardiology associates you have a physician practices you have hospitals you have health plans, there is no single kind of entity that has been able to -- that doesn't end up becoming subject those sorts of deficiencies and enforcement.

I also want to call your teengs to the biggest of the cases because it points to another issue that's really important. The biggest case that we did, the one that resulted in the most serious fine, was not about privacy requirements, it was not about security requirements, it was about access requirements. It was a provider who filed to give patients access to their records, and then chose not to cooperate with our investigation.

So that is as much an issue from OCR's perspective as privacy and security. And as I've said before, HIPAA is a valve, not a blockage. It is at the end of the day meant to ensure that what health records are used for is for the benefit of the patient. That means the patient needs to get the records when they need them, it means the patient's other providers need to get them when they need them, it just means they need to be private and secure from anybody who doesn't need them for the health care of the patient or for the health care operations of a particular covered entity.

So the last thing I want to talk about, I think my time is coming to a conclusion, is having said all of that, we want to make sure that the industry has in its hands what it needs to be able to effectively comply. And I will be transparent with you that in both audit and in our overall enforcement work, one of the particular areas of vulnerability that we have found is with smaller providers. It's with that individual doctor's office or with that small medical practice or that small pharmacy. And so we understand that the burden on us is to make sure that we are effectively reaching and educating that part of the industry.

So on the one hand we talk about enforcement, but at the same time we're talking about education.

So here there's ryrchs to some videos that OCR has prepared you're going to see some additional materials that ONC and OCR together have prepared, and there is extensive material on both our website, ONC's website, and other resources available to be able to comply. And we want to continue in a dialogue with you, to make sure that those are the materials that you need.

Because I'd rather go out of business. I'd rather not have to be in this business. And I actually believe that the time will come where this will be so second nature in the industry that we will no longer be talking about million and 2 million dollar recoveries. We'll be talking about a very different environment.

So thank you for your time, it is now my pleasure to introduce Catherine martricini from the office of the national coordinator for health information and technology. I asked her what her title was, and she would not tell me. So I have designated her a title. She is today the guru of health privacy for the office of the national coordinator. So welcome, please, Catherine. (Applause.)

Gotta run.

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More to come...