IT Leaders: Prepare for Personalized Medicine

Nov. 25, 2009
PM is a disruptive force in medical practice that has been evolving rapidly over the last few years.

As the drive toward global adoption of electronic health records (EHRs) gains momentum, the need for provider organizations to leverage these expensive investments gains importance. American Recovery and Reinvestment Act payments represent a short-lived financial benefit. Where, however, are the more-significant opportunities to transform care and generate significant long-term value from EHR investments?

Personalized medicine (also known as genomic, molecular, information-based or precision medicine) is a disruptive force in medical practice that has been evolving rapidly over the last few years. By guiding physicians to the most-effective treatment for each patient based on their individual disease state, as well as helping to avoid treatments that are of no value or are likely to have adverse effects, personalized medicine improves outcomes for the patient, saves time and reduces waste in medical care by avoiding inappropriate interventions.

As the drive toward global adoption of electronic health records (EHRs) gains momentum, the need for provider organizations to leverage these expensive investments gains importance. American Recovery and Reinvestment Act payments represent a short-lived financial benefit. Where, however, are the more-significant opportunities to transform care and generate significant long-term value from EHR investments?

The key to value is in the information stored in the EHR, and the ability to rapidly collect, access, manage, analyze and disseminate data at both individual and institutional levels. These capabilities provide the pathway to a form of medicine that is personalized, pre-emptive, predictive and patient-centric.

Personalized medicine (also known as genomic, molecular, information-based or precision medicine) is a disruptive force in medical practice that has been evolving rapidly over the last few years. By guiding physicians to the most-effective treatment for each patient based on their individual disease state, as well as helping to avoid treatments that are of no value or are likely to have adverse effects, personalized medicine improves outcomes for the patient, saves time and reduces waste in medical care by avoiding inappropriate interventions.

The promise of genomic medicine is finally being matched by the availability of technologies to support its deployment to clinicians at the point of care. There are numerous signs across the health-sciences landscape that the coming wave of personalized medicine has already begun to build momentum:

  • The number of molecularly guided diagnostic and therapeutic products on the market has tripled over the past three years.
  • An increasing number of genes are being found to have clinical relevance, leading to the development of highly targeted therapeutics with associated molecular diagnostics for patient selection.
  • Drug development is being re-engineered to accommodate molecular sub-grouping of patient populations, and the FDA is adapting its oversight of drug development, approval and labeling along molecular lines.
  • Congress passed a “Genetic Information Non-Discrimination Act” in 2008 to remove the threat of insurance denials based on genetic profiling.
  • CMS and private insurers are preparing to realign provider payments to health maintenance and the quality of clinical outcomes, rather than simply reimbursing for services provided after the onset of disease.
  • Medical schools are instituting new genomics-in-medicine programs.
  • IT developers are turning out a new generation of data-management tools that permit the integration of disparate types of clinical and biological information, as well as clinical decision-support tools.

Personalized medicine approaches engaged as part of a comprehensive clinical strategy will enable providers to fully leverage their EHR investments and deliver, with precision, the right treatments and care processes to increasingly demanding healthcare consumers.

Since the implementation of personalized medicine requires thoughtful IT planning and IT-enabled communications targeted to every internal and external constituency, business and technology leaders at all provider organizations should begin preparing now for their role in the adoption and deployment of personalized medicine.

At H. Lee Moffitt Cancer Center in Tampa, for example, the development and deployment of personalized medicine capabilities has been focused around the organization’s “Total Cancer Care” (TCC) program. Patients signing up for TCC provide authorization for their genomic data to be securely stored and made available for research purposes, but also tied to an information-systems architecture that brings together information from the EHR and clinical-trials systems so that patients can be quickly matched to promising new treatment protocols specific to their disease.

The next step will be to establish a personalized patient portal that will continue to provide support to cancer survivors after they have returned to the community, with links to targeted support services where they live.

In creating the technical infrastructure to support TCC, Moffitt found that the necessary integration of data from multiple sources ran into the usual problems related to data standards, terminology, structure and consistency. A significant, focused work effort was required at Moffitt to achieve acceptable internal standardization of data.

Beyond the implementation of technology, and the challenge of achieving semantic interoperability, IT leaders should be ready to meet other strategic organizational challenges associated with personalized medicine programs. These include:

Privacy and security: Data security remains paramount, and the presence of strong business-associate agreements with all technology and data-management partners will be important to protect patient privacy and confidentiality.

Data management and analytics: Sophisticated data-warehousing and business-intelligence tools are needed to store the massive amounts of data involved, and make it accessible to a diverse group of customers. Analytics tools provide the real-time decision support that allows clinicians to make decisions based on comparative analysis across closely matched patients.

New provider roles: Provider organizations will need to expand the roles and the numbers of genetic counselors, case managers, quality managers and translational-research professionals.

Payer demands: Genetic information that drives the appropriateness of certain treatments will become part of the complex algorithms used to determine provider payments. Information systems supporting patient identification, health-information management and revenue-cycle processes will form part of the technical infrastructure behind personalized-medicine deployment.

Paul Murphy is a senior manager at Kurt Salmon Associates, New York, a consulting firm that provides strategic advisory services to healthcare provider organizations. Marcia A. Kean is chief executive officer of Feinstein Kean Healthcare, Cambridge, Mass., a consulting firm that provides services to a wide range of academic medical center, government and commercial clients.

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