Irreconcilable Differences? The Case for a Balanced Approach to Health Information Privacy Regulation

April 13, 2009 by

I marked my 10th college reunion with a miscarriage.  It was my first pregnancy, and although I was well past 30, I was not remotely prepared for the physical loss, let alone the emotional one. 

I flew home to the East Coast that night.  When I arrived at the registration desk of a highly regarded academic medical center for a D&C the next day, I was handed an “informed consent” document typical of the period.  It included provisions to the effect that excess specimens (which otherwise might be discarded) and information about me and the care I received might be used for research and that as a patient at an institution of higher learning, I agreed to this disposition.  My profound grief temporarily gave way to outrage, and I marked up the document – an occupational predilection of a young lawyer regardless of distressed mental state – to allow the hospital to bill my insurance company for my treatment but not much more.  I handed it back to the receptionist, who curtly informed me that I could sign the form “as is” or be denied treatment.  I had no energy to put up a fight and was in too much pain to walk away, so signed a fresh copy with some vague intention to take it up again later.

 Many years (and three healthy kids) later, I understand the significance of that simple consent – or really notification – process in enabling the clinical trials, health services research, and related public health activities so critical to learning about disease, developing new prevention strategies and interventions, and improving health outcomes.  I appreciate that our expectation of continuous advances in science and medicine requires some measure of sacrifice.  And I now recognize that it is imperative to make the best use possible of existing data and human tissue that otherwise would be discarded, especially as health care costs soar, resources disappear, and consumers, payors, and government officials increasingly and loudly demand that  health care delivery and payment systems become more efficient and effective.  Barak Obama pointed to the importance of health services research during his 2008 presidential campaign in his Plan for a Healthy America:

One of the keys to eliminating waste and missed opportunities is to increase our investment in comparative effectiveness reviews and research. Comparative effectiveness studies provide crucial information about which drugs, devices and procedures are the best diagnostic and treatment options for individual patients. This information is developed by reviewing existing literature, analyzing electronic health care data, and conducting simple, real world studies of new technologies.

Congress embraced this approach in the American Recovery and Reinvestment Act (“ARRA”), appropriating $1.1 billion to comparative effectiveness research and establishing a Federal Coordinating Council for Comparative Effectiveness Research to “foster optimum coordination” and avoid “duplicative efforts”.  The legislation requires the Council, whose members were named in mid-March, to submit its first report to Congress on June 30, 2009, and in it to describe current activities and recommendations for use of the appropriated funds. 

Yet we are in real danger of squandering the tremendous opportunities those funds provide to advance scientific knowledge and translate that knowledge to medical practice.  Why?  Because single-issue privacy hawks have succeeded in recent years in focusing public attention and concern on individual privacy rights without regard to the consequences for society.  The foundational conceptions of a civil society or the common good seem almost entirely absent – or at best an afterthought – in current academic and political discourse on the “ethics” of research with human biospecimens and personal health data.

For example, the federal HIPAA Privacy Rule, which recently has been integrated in significant part and expanded upon in federal legislation through a section of ARRA titled the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, do not recognize research or public health activities as integral to a functioning health care system.  The Institute of Medicine is just the latest organization to investigate the challenges this rule imposes to the pursuit of research and public health activities and recommends several policy changes aimed at mitigation.  I have opined elsewhere that the challenges are due largely to the failure of the HIPAA Privacy Rule to recognize research as equally integral to the delivery of health care as accreditation, peer review, quality improvement, and other activities without which there is no ultimate accountability in the health care system.  This failure, in turn, results in over-valuing “autonomy,” a core privacy right that the HIPAA Privacy Rule is designed to protect.

To my knowledge, the cost of this construct to advancing knowledge and discovery and informing public policy has not been systematically weighed against the questionable benefits the HIPAA Privacy Rule and similar efforts bestow on individual rights.  Fred Cate’s brief but cogent piece delivered to the 2007 Privacy Symposium in Cambridge, The Autonomy Trap, explains how our overwhelming concern with individual choice or control, reflected in laws and regulations mandating various procedural protections, does not actually do a very good job serving its intended purpose of protecting substantive privacy rights.  He argues forcefully that we should permit the use of medical records for research without individual consent, by recognizing the distinction between “privacy of the body – the right to refuse treatment or to choose among medically appropriate treatments – and privacy about the body.”  Quoting from Helena Gail Rubinstein’s article, “If I Am Only for Myself, What Am I?  A Communitarian Look at the Privacy Stalemate,” 25 Am. J. Law & Med. 203 (1999), Cate observes that “relying on consent refuses to recognize ‘in exchange for the vast improvements in medical care, a correlative responsibility on the part of the individual, as a potential consumer of health care services, toward the community.  As individuals rely on their right to be let alone, they shift the burden for providing the data needed to advance medical and health policy information.  Their individualist vision threatens the entire community[.]’” 

 As the current Administration and responsible agencies work to develop regulations to implement the HITECH Act’s (and GINA’s) new privacy and security provisions, it will be incumbent on them to consider the impact the regulations will have on comparative effectiveness and other health services research, with the ultimate goal of reasonably balancing individual privacy rights against scientific discovery, biomedical innovation, and quality improvement.  The stakes are far too high to continue pursuing the goals of scientific and medical advancement, on one hand, and protection of individual privacy rights, on the other, in separate silos.  It is my hope that, pursued together, these initiatives will result in reasonable compromise, for example by enhancing education and transparency about research uses of secondary data (and excess biospecimens) while reducing unnecessary regulatory barriers to bona fide research uses of these invaluable resources.

-Rachel Nosowsky, Senior Counsel at Miller Cannfield

Creating the regulatory framework we need

February 9, 2009 by

“In recent days, there have been misguided criticisms… [suggesting] that we can meet our enormous tests with half-steps and piecemeal measures… I reject these theories”

President Barack Obama, Washington Post, February 5th, 2009

The Obama Administration’s attempt to create the 21st century government “we want” has again confronted the 20th century government “we have”. The Washington Post reported on January 31st that in an attempt to add accountability to the recipients of Troubled Asset Relief Program resources the Obama team hit the brick wall of federal regulations. Turns out, the Paperwork Reduction Act of 1980 prohibits the Obama team from asking recipients what they did with the billions of dollars they received without Office of Management and Budget (OMB) clearance. As reported in The Post, this clearance process can take up to months and can only be waved when “lives are at risk”.

The Paperwork Reduction Act represents but one example of legislation whose good intention in one context blocks noble objectives in another. Biomedical researchers are all too familiar with the alphabet soup of regulations: FDAAA, 21 CFR Part 11, FISMA, HIPAA, to name a few. Moreover, these regulations are interpreted and enforced by a government that has been progressively hobbled for the past 20 years by bipartisan consensus (“government is the problem” – Ronald Reagan, “the era of big government is over” – Bill Clinton). The consequence is Lilliputian ropes binding the giant biomedical enterprise. These bindings impair natural synergies between research and care as well as foster a perverse set of misaligned incentives. For example, the Institute of Medicine’s Committee on Health Research and the Privacy of Health Information this week released a report in which it concludes: “the HIPAA Privacy Rule does not protect privacy as well as it should, and that, as currently implemented, it impedes important health research”.

The current economic crisis we face clearly indicates that the answer is not deregulation. When it comes to healthcare one can not count on altruism and organizational “better angels” to protect privacy, safety, security. Instead, what is needed is a holistic, systematic examination of the patchwork quilt of regulations in the context of 21st century biomedicine opportunities. A significant challenge confronting such an examination is that biomedicine is not currently constituted as a system but instead is a collection of highly fragmented, disconnected, silos.

The BIG Health Consortium™ represents a laboratory where such a systematic assessment could be performed. The BIG Health ecosystem contains the diverse stakeholders throughout biomedicine: consumers, care deliverers, researchers, government, academe, industry, non-governmental organizations. The consortium’s projects will represent real-world applications that demonstrate the regulatory challenges and in which solutions could be contemplated. Because of the diversity of the ecosystem it may be possible to anticipate “consequences” that would otherwise appear as “unanticipated”. The BIG Health Consortium™ inherits the caBIG® community’s pioneering work on data sharing, intellectual capital, and security. The framework created by this community represents solid foundational stones on which to build.

There are many additional natural partners to this endeavor. For example, I had the opportunity to present the BIG Health Consortium™ effort to a luncheon meeting of the American Health Lawyers Association Teaching Hospitals and Academic Medical Centers Practice Group. This group is on the frontlines of the day-to-day struggle of moving biomedicine forward. I invited them to join the BIG Health Consortium to help us create the necessary regulatory framework that balances private interest and public good and make 21st century biomedicine a reality.

Help me, Obi-Wan Kenobi; you’re my only hope.

January 26, 2009 by

“The question we ask today is not whether our government is too big or too small, but whether it works” President Barack Obama, Inauguration Speech, 2009

A wave of change is breaking over the United States. Whether that wave will sweep in a much needed change into a 21st century biomedical system or harden the silos of 20th century paradigms is yet to be determined. One thing is certain, the developing legislation – the American Recovery and Reinvestment Act of 2009 will change the landscape of biomedicine. Two provisions are noteworthy: the Act’s support for electronic health records and comparative effectiveness research. There is substantial investment in both areas. The devil will be in the details. How the noble ideas are translated into action will determine success or failure of the intentions.

The BIG Health Consortium™ represents a prototype of the 21st century health care “system”. Our ecosystem could serve as a model for the Learning Health Care System needed to inform and sustain a stable, knowledge-based system that focuses on quality and effectiveness. The BIG Health Consortium™ is in an ideal position support a 21st century model of comparative effectiveness – molecularly-informed comparative effectiveness. Traditionally comparative effectiveness studies examine average effectiveness based on broad populations. Such broad comparisons do not account for what we now know about the molecular characteristics of diseases and individuals, and the critical relevance of that knowledge in effectively preventing or treating disease. For example, molecular characterization has already elucidated cancer as a family of sub-types that can only be identified at the molecular level. There are a plethora of molecular tests now used in clinical practice that define subgroups and guide intervention and treatment. 21st century comparative effectiveness must include these stratifications to “do no harm”.

The Obama team squarely confronted the realties of the 20th century this week. The Washington Post reported the Obama team found itself in the “Technologic Dark Ages” as it moved into the White House and “encountered” the realities of federal information technology. Masters of the use of 21st century technology, they experienced first hand the labyrinth of policies, procedures, and interpretations that hobble national efforts. Most symbolic was the attempt to separate President Obama from his Blackberry. In what may be the first true victory for 21st century thinking in information technology in the executive branch, the President retained his Blackberry. Hope springs eternal that this enlightened approach to technology will similarly clear the Byzantine barriers that slow the deployment of an electronically-connected, 21st century ecosystem in biomedicine.

“General Kenobi: Years ago, you served my father in the Clone Wars; now he begs you to help him in his struggle against the Empire… This is our most desperate hour. Help me, Obi-Wan Kenobi; you’re my only hope.” Princess Leia – Star Wars.

Change we don’t need to fear…

November 24, 2008 by

Dr. Ken Buetow, BIG Health Catalyst

“The future is already here – it’s just not evenly distributed.”
– William Gibson, quoted in The Economist, December 4, 2003

There is an anxious excitement that change is on the horizon. There is little debate that change is needed. What produces the tension is the dilemma of ensuring that what is good is retained while fixing what is bad. My conservative Indiana “Hoosier” roots remind me that “If it ain’t broke, don’t fix it”. Change can cause damage as well as improvement.

The Biomedical Enterprise squarely faces this dilemma. The 21st century is commonly referenced as the “century of biomedicine”. A new generation of personalized medicine promises the delivery of the right intervention, to the right individual, at the right time. Unfortunately, tremendous barriers stand between the promise and delivery of personalized medicine. The cost of translation and development of next generation interventions is sky rocketing. Molecularly-targeted therapeutics are among the most expensive interventions available. An aging population threatens to expand the already 16% of Gross Domestic Product (GDP) spent on health care. Perverse misalignment of incentives blocks the adoption of the new paradigm.

Given the near universal recognition of the challenges faced by biomedicine why is it so difficult to adopt the practices that create solutions? Clayton Christensen of the Harvard Business School in “The Innovators Dilemma” suggests that this type of change is difficult because business practices by those successful in the current paradigm do not incentivize the necessary innovations. An example from another industry is illustrative.

In the early 1980’s “serious” computing was still performed on mainframe and mini computers. The market for these computers was small and they were sold at high price to a small numbers of institutions that could afford their high price tag, the special infrastructure need to house them, and the highly trained users who could master them. IBM was the unquestioned master of the mainframe computer world (its competitors were referred to as the “7 dwarfs”). Its approach to mainframes was common across the industry. New computers were designed by small, internal teams of highly specialized experts and composed entirely of components made within house, in this instance IBM. Mainframe and mini computers were high profit margin products.

At the time, the newly emerging personal computers (PC’s) were toys. They were sold through retail outlets and seen as consumer entertainment devices. Their most enthusiastic adopters were hobbyists and they were felt to have little practical application. They were relatively inexpensive and had low profit margins.

The “real” computer industry struggled with how to approach the PC. When projected against very well understood business models, they didn’t make sense. Existing mainframe customers had little interest in PC’s because they did not perform any functions of value. Their tiny profit could not justify investment in manufacturing or sales. The absolutely correct business analysis at the time suggested it was a distraction to invest in PCs.

Unique within the established computer industry, IBM recognized that to enter the personal computer market it would need to fundamentally alter its business strategy. First, it created a new business unit that was largely independent of existing management. This permitted the unit to explore approaches outside of “business as usual”. IBM had deep institutional knowledge of what was necessary to have a complete computing “system”. To achieve this system, it utilized a “network” model. Instead of creating all the components internally, it instead assembled “off the shelf” parts from different manufacturers. This permitted lower overhead as design and development costs were born by the external original equipment manufacturers (OEMs) and higher margins for the “orchestration” efforts performed by IBM. To make this approach work, IBM created an open architecture and defined interoperability standards for the components. It published these standards and described the “slots” available to plug components into its platform. The IBM PC transformed personal computers and the personal computer market.

The echoes of mainframe computer manufacturing can be seen in today’s biomedical enterprise. Existing, successful organizations struggle to see why they should change. Like “IBM and the seven dwarfs”, even those groups who wish to be on the innovative edge struggle to see how to make it a sustainable activity. Absolutely correct business analysis does not show how a single organization or entity can address the challenges or grab the opportunities of 21st century biomedicine.

Through the BIG Health Consortium™ we strive to accomplish the 21st century biomedical equivalent of IBM’s personal computer model. First we are considering biomedicine as a “system”. This systems approach aims identify all the parts necessary to connect discovery, translation, and care. BIG Health also utilizes a network model. Instead of creating a new, monolithic organization that has all the parts, BIG Health is orchestrating “OEM contributions” from the multiple stakeholders within the biomedical ecosystem. This network model re-aligns incentives and balances contributions.

Like the IBM PC this ecosystem includes novel innovators in biomedicine. Who had ever heard of Microsoft before the IBM PC? For example, the BIG Health Consortium™ contains groups such as personal genomics companies that uniquely target consumers and are dismissed by some members of the biomedical establishment as “entertainment”. Sound familiar?

The BIG Health OEM network model is enabled by open architecture-based interoperable informatics capability – the “BIG” in BIG Health. BIG connectivity “unlocks” data. The BIG Health Consortium™ permits work to be performed through virtual, on-demand, “cloud” organizations.

Finally, while the BIG Health Consortium has the capacity to become a disruptive innovation, it is not by definition disruptive. Like the IBM PC effort it can be explored in parallel to the existing, successful paradigms in biomedicine. It cost efficiently recycles existing capabilities in novel ways. BIG Health is a way of living in the future without leaving the present.

Connections Matter

November 21, 2008 by

There is a developing conversation around “Science 2.0,” where it is argued that the application of social networking platforms that have proven so successful in other contexts can be leveraged to enable and improve scientific collaboration. Tools like blogs, wikis and forums as well as the scientific equivalent of Facebook/MySpace are already being used by members of the scientific community, sometimes with large and enthusiastic communities of participants. The active participation in sites like and Epernicus illustrates that scientists as a group have an interest in social networking, and are willing to make use of such infrastructure when it supports their business/science goals.


It is not enough, though, to build instances of existing tools and expect that the scientific users will flock to them and immediately figure out ways to use the infrastructure to support their work. What is constructed must fit into useful paradigms of scientific activity, and tools must truly reflect the activities and work process of the scientists who would use them. This approach must go beyond the “electronic lab notebook” that has been the dominant paradigm for collaborative systems in science. It requires a close examination of how scientists actually work today, and a reasoned approach to how that work will change in the future. By mindful watching of scientists at work, listening to their concerns and interests, and having a willingness to push the envelope on the existing tools, it will be possible to create novel systems that go beyond simply mimicking the existing processes. It will also be necessary to engage scientists at all levels. Although it is tempting to focus solely on the senior-most researchers, it will be critical to engage younger scientists and those engaged in the more mundane technical activities to create real and lasting value in tools that support research.


I have been involved as a member of the Data Portability Project Healthcare Task Force, and have had the opportunity to see how the standardized and interoperable exchange of data can enable, enhance and support the needs of a widespread scientific community. The Data Portability Project defines itself as “the option to use your personal data between trusted applications and vendors.”  This represents a generalization of what we have been talking about in the BIG Health Consortium™ – namely that providing our participants, whether they are patients, clinical researchers, basic scientists, or physicians the ability to safely and securely share data with their caregivers, colleagues and collaborators is critical in order to move to the next level of translational research and to realize the promise of personalized medicine. Obviously, concerns about privacy, security and safety are important in our health care and health research space, but equally important will be providing a means for those engaged in these activities to access (and control access to) the electronic component of their information. Beyond simply supporting the secure exchange of data, the ability to effectively participate in new and more integrated ways as a part of the scientific research community as a whole can give stakeholders a sense of belonging to the process, which can enable entirely new communities that transcend the traditional divisions between patients, physicians and researchers.   


Our community needs to engage in the development of meaningful new methods for communication and collaboration around our research, and participate in activities like the Data Portability project in order to ensure that the ”voice” of basic science research and translational medicine does not get lost in the broader and more general conversations about storing, accessing and making use of health data. It is my fond hope that the BIG Health Consortium™ and related efforts like caBIG®® will provide us with a community base for these discussions and thus ensure the best possible outcome for our research community, and for the patients whom we ultimately serve.


-Mark Adams, BIG Health Futurist

Bows and flows of angel hair…

November 11, 2008 by

Dr. Ken Buetow, BIG Health Catalyst

And ice cream castles in the air, And feather canyons everywhere, I’ve looked at clouds that way. (Both Sides Now, Joni Mitchell 1967)
Clouds are all rage! The virtualization of computer resources – the shift from using storage, computing power, and applications on computers you can touch to accessing these resources through the internet has caught the attention of the lay press.  No longer the domain of arcane “geek-speak” PowerPoint presentations where we drew the internet as a cloud (the “cloud” in “cloud computing”), the cloud has spilled over into mainstream media such as Newsweek and The Economist.
The concept is not new and some of the cognoscenti (think Larry Ellison of Oracle) are asking what all the fuss is about.   Industry leaders such as IBM and Oracle have been talking about On Demand Computing and Grid computing for some time.  Much of this is the natural progression of what of Sun Microsystems meant when they adopted the motto: “The Network is the Computer™” two decades ago.   Pioneers of e-business such as CommerceNet have extended the concept to use virtualization to create new business models that have transformed much of industry.  If the concept is not new, why the excitement?  One reason may be that there is a major new player using “the cloud” – consumers.  As millions of consumers have become “wired” through high-speed internet connections and everyday devices such as cell phones, and PDAs connect to the internet a whole new market has opened.
A “new” Cambrian Explosion.
Irving Waldawsky-Berger, an IT thought leader from IBM, suggests that cloud computing may launch a new Cambrian Explosion and that it may be the “next Big Thing” in information technology.   The Cambrian Explosion refers to the period in evolution about 530million years ago where there is a sudden, rapid increase in the number and complexity of species.   Arguably, this occurred as evolution “mastered” the concept of multi-cellularity.  Two features are key to creating multi-cellular organisms.  First, to make the organism efficient evolution needed to figure out how to re-use components of the genome without duplicating them.  Second, it needed to master inter-cellular communications so that the organism could work together, as a whole.
The current day advantages of “multi-cellularity” have been recognized by economists for some time.  Adam Smith in his 18th century Wealth of Nations speculated that economic success was driven by greater productivity and that the greatest improvement of production came from the division of labor.  He further suggested that division of labor was limited primarily by the market of those consuming the specialized services. Through cloud computing organizations do not have to duplicate expensive functions that can be more efficient delivered on an industrial scale by others.  This permits a group to focus precious resources on core business aspects and cost-efficiently consume other capabilities at commodity prices.   Cloud computing is predicated on the availability of diverse resources that can be accessed from a multitude of appliances using common connection protocols.
BIG Health Consortium as Cloud
I will leave it to the “captains of industry” to debate whether cloud computing is new or whether it is an evolutionary concept in the commercial sector.   In biomedicine the cloud concept has the capacity to be revolutionary.  Biomedicine exists metaphorically in a Precambrian state.  Like low complexity organisms, each individual, organization, and institution carries the burden of having to do it all.  Biomedicine struggles to capture the synergy of specialization. 
The BIG Health Consortium™ seeks to create and leverage a novel biomedical “organism”.   The BIG Health market place offers up specialized capabilities that can be assembled in unique combinations. Underpinning BIG Health is BIG, the Biomedical Informatics Grid – a cloud that connects the diverse communities and their unique specialties.  Each participant can contribute their novel capabilities and consume of the capabilities of others.  BIG Health’s Web 2.0 approaches to community building offer a strategy for virtual organization coordination.
The BIG Health Consortium™ projects will demonstrate the power of this new model.  Like the Cambrian Explosion it is hoped that this new model will allow biomedicine to efficiently exploit resources and venture rapidly into new places – to address problems that are beyond the reach of current approaches and to demonstrate the reality of personalized medicine.

BIG & A Rapid Learning Network for Children’s Health

October 14, 2008 by

There are so many possibilities for a BIG Health Consortium that is difficult to figure out where to begin! One of the areas with a lot of need – and potential — to be considered is children’s health. There are large gaps in the clinical evidence base for care of children, since they are usually excluded from randomized clinical trials. Moreover, most pediatric practices are small, which limits the ability to advance research on children’s health issues by using registries and databases. There is a particular scarcity of pediatric databases that included patient genetic data.

Pediatric oncology offers an example of where a national effort to develop collaborative research and share data about nearly all children with cancer has resulted in great advances in clinical outcomes. Another example of successful collaboration in a selected children’s health area is the CDC’s Vaccine Safety Datalink, which draws on databases from eight large HMOs. Recently, Children’s Hospital of Philadelphia has been discussing creating a research network of children’s specialty institutions, many of which use the EPIC software platform. There are many potential participants for a national children’s health network, ranging from large organized systems (like Kaiser-Permanente) to academic health centers and community practices.

BIG Health could be the catalyst to create a data-sharing framework for a comprehensive system for children’s health research.

-Lynn Etheredge

BIG Health & New Technologies

October 7, 2008 by

I think there are major opportunities for BIG Health to create a national system to learn as much as possible, as soon as possible, about the best uses of new technologies.

How might BIG Health contribute? Here’s a sketch of what could be done: Early after a new technology is introduced – ideally, the point of FDA approval, or Medicare coverage, of a new drug, device or procedure – HHS (BIG Health, NIH, FDA, AHRQ, and CMS), with the private sector (physician specialty societies, health plans, researchers, biotechnology and device industry) would develop a national research plan that identifies important effectiveness and safety questions to be answered (e.g. over the next three years), specifies the data needed to answer the questions, and blueprints a linked system of clinical registries to gather the data and make it available for research. In this initial period, major public and private insurers would agree to make their payments be contingent on provider reporting of the needed information to the registries.

BIG Health could have a key role in creating this national system: (1) as a convener, within HHS and with outside parties, to identify research questions and resolve the technical issues needed to create the registries and enable sharing of data; and (2) via BIG’s capabilities, to enable the data-sharing and research projects to proceed quickly and smoothly, connecting many interested parties and collaborators. Absent such an initiative, efforts to learn about new technologies will continue to be a huge problem area for everyone. Working with others, BIG Health could pick several new technologies for national demonstrations.

These BIG capabilities would likely have a lot of use. Both the new FDA Sentinel Network legislation to study drug safety (with up to 100 million patients) and pending legislation for a national comparative effectiveness initiative will need a capacity to carry out studies that can access many databases. Even more urgently, physicians and patients need to know quickly if new technologies offer better results for individual patients. And new technologies are a great place to start: by definition they are where we have the most to learn.

-Lynn Etheredge


October 2, 2008 by

Dr. Ken Buetow, BIG Health Catalyst

The last couple of weeks have definitely brought to mind the ancient Chinese blessing/cure – “May you live in interesting times”. As the world churns around us, we are reminded of the complex interactive networks that tie together so many apparently disparate pieces of the world. Biomedicine represents one of these complex interactive networks. I participated in two fascinating conferences during the past 2 weeks that provided two synergistic views of the biomedical ecosystem with implications for BIG Health.

The first conference was the 5th European Conference on Complex Systems held this year in Jerusalem. Wikipedia defines a complex system as “a system composed of interconnected parts that as a whole exhibit one or more properties not obvious from the properties of the individual parts”. At the conference, complex systems in physics, biology, economics, art, and music were discussed and analyzed. Work was presented from ecology studying “real” ecosystems. As well summarized in the Wikipedia entry, complex systems share common properties. Key among these are that the systems boundaries are difficult to determine, that they may be systems of systems, they operate as networks, contain feedback loops, have non-linear effects, and demonstrate emergent properties.

The second conference was titled “Health Care Systems of the Future” sponsored by University of California San Francisco Center of Excellence for Breast Cancer Care and Physicians’ Education Resource. The conference brought together diverse stakeholders in health care and research representing academia, government, and industry. The goal of conference was to begin creating the high quality, coordinated systems of care that are linked to the research community to facilitate evidence based management in medicine. The conference explored many of the challenges facing health care. It also highlighted several examples of success. Common among the examples of success was the organizations recognition and leveraging of the systems nature of the problem they were addressing. In one example, Kaiser Permanente Health Care, the systems approach is accomplished implicitly because the group is an integrated deliverer of health care, acting as both payer and provider. They can therefore describe their boundaries, can formally control portions of the network and leverage the appropriate feedback loops to get non-linear effects. A second example was Geisinger Health Care. While geographically defined and having an integtrated component, Geisinger is an open system. It has a system within a system. It explicitly leverages its internal system to maximize the effectiveness of the larger, open portion of its network.

The insights obtained at the intersection of the two meetings provide important lessons for our emerging BIG Health Consortia. As BIG Health moves forward with its demonstration projects it becomes clear that broad engagement of the diverse biomedical stakeholders will be essential for success and necessary to create a self-supporting ecosystem. Moreover, by consciously considering the network of interactions we will be able to leverage the non-linear aspects of the complex system, amplifying the contributions of the consortia.

PCAST and Personalized Medicine

September 18, 2008 by

Today, the President’s Council of Advisors on Science and Technology (PCAST) presented its report “Priorities for Personalized Medicine.” I recommend that you take a gander at what’s been cookin’ with them.

PCAST is a body appointed by the President comprising the Director of the Office of Science and Technology Policy and members from outside the Federal government with diverse expertise in science, technology, and the impact of science and technology to provide advice on matters of science and technology policy. Kathy Behrens and Floyd Kvamme–the co-chairs of this report–are real icons in the health technologies and private investment world and know the biotechnology space, and most importantly, know how to do the future value scoping of what this all means to health care.

Apparently, this is pretty important to them. They take an outside-in view on three vectors of Personalized Medicine–technology and tools, regulation, and reimbursement for its policy considerations. This report brings under one banner some of the key views of whether yesterday’s health care system can accommodate these new capabilities or whether systems change is needed to enable the value and capabilities of genomics, health IT and evidence-based medicine to reach its pinnacle of opportunity.

Maybe this will be the report that starts the conversation to bring into scope the actions needed across academe, business, and government to enable the full potential of personalized medicine to come into focus. Incremental (accidental?) change vs. a strategic redesign for the application of technology and knowledge is the crossroads we’ve reached. Maybe their work is the fulcrum for deciding who’s onboard for this transformation and who’s happy with the safe and predictable footing we’re on and waiting for others to decide the path forward. Maybe it’s time to raise the stakes. This work by PCAST brings together the major steps to be considered for the value of health care and who’s in and who’s out. Judge for yourself if this is the direction we should go – as a community of the willing.

-Greg Downing, DO, PhD