Personalized health care focuses on genomics, specifically the identification of genes and relationship to drug treatment, to allow for tailoring of medical treatment. HHS had established two broad goals for Personalized Healthcare in their September 2007 announcement:
- Provide federal leadership supporting research addressing individual aspects of disease and disease prevention with the ultimate goal of shaping preventive and diagnostic care to match each person’s unique genetic characteristics.
- Create a “network of networks” to aggregate anonymous health care data to help researchers establish patterns and identify genetic “definitions” to existing diseases.
The workgroup reported that pharmacogenomics' use in clinical practice has been slow due to:
- "Lack of an evidence-base and information on clinical utility
- Lack of clinical guidelines for the use and interpretation of pharmacogenomic tests in pharmaceutical selection and treatment decisions
- Impediments to reimbursement for the performance of laboratory tests
- Paucity of clinical practice experience with pharmacogenomic test"
The workgroup's June 3 recommendations include:
- EHR Standards to Enable Clinical R&D: Expand standards to include pharmacogenomics data, within the context of informed consent and privacy considerations. Establish EHR minimum data sets to support clinical interventions based on pharmacogenomics data with demonstrated clinical validity and utility. Pilot unidirectional flow of this information from EHRs for clinical research.
- Clinical Decision Support: As Clinical Decision Support (CDS) approaches and standards are integrated into healthcare IT, the implications of pharmacogenomics should be taken into account.
- Medication Prescribing: HHS should work with stakeholders to document challenges, opportunities and information flows related to dispensing pharmaceutical drugs based on pharmacogenomic test-derived interpretations.