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A pioneer in clinical informatics with the development of the the Veterans Health Information Systems and Technology Architecture (VistA), the U.S. Department of Veterans Administration is again on the forefront of the design and development of a new VistA Electronic Health Record (EHR). Using innovation as the major theme involving academia, the commercial sector and the […]
In some cases, the utility of patient genotyping prior to therapeutics is of unquestioned value. In non-Hodgkin’s and Mantle Cell lymphoma, DNA sequencing of the tumor provides personalized cancer vaccines that demonstrate statistically significant Phase III clinical trial results with disease-free survival benefit in treatment of these types of follicular lymphoma [1]. The Oncotype DX® […]
Clinical practitioners can now interactively produce and query a patient report for genetic tests spanning over 2000 inherited diseases from a single whole-genome sequence, using www.genetests.org (www.ncbi.nlm.nih.gov/sites/GeneTests/?db=GeneTests) as a valid guide. GenomeQuest (www.genomequest.com) , a company based near Boston, MA, which serves as the data management provider for most of the U.S. pharmaceutical industry, has […]
There was a very interesting meeting yesterday, “The Personal Health Record (PHR) Roundtable”, organized by the Office of the National Coordinator for Healthcare Information Technology (ONCHIT). Some of the more enlightening discussions took place in the afternoon sessions, focusing on security, privacy and standards. Josh Lemieux, Director of Personal Health Technology, Markle Foundation and Dr. Matthew […]
Over the past several years, we have seen segmentation of EHR product offerings, usually tailored for different clinical settings. In a domain such as Radiology, the specialty requires integration of PACS into the EHR. However, in certain specialties such as oncology, the federal government, professional organizations, and even patient advocacy groups have recommended that the […]
A prominent CIO of a regional hospital system encountered the limitations of HIPAA and so-called “Protected Health Information (PHI)” when her boss fired her after a short medical leave of absence. After years working without taking vacation, a family catastrophe that affected her health prompted her to take a medical leave of absence. She had […]
The FDA has been receiving a great deal of criticism from the clinical community about a variety of issues, but probably none is as contentious as the ongoing patient safety issues regarding harmful drug-drug interactions and drug-gene interactions, estimated by the Institute of Medicine to cause 250,000 deaths each year in the U.S. The current […]
It’s not just genomic scientists that are dealing with enormous amounts of DNA sequence data – the clinician will soon be next. However, the explosion in linking disease with genetics, and the realization that the FDA will require gene testing prior to the prescription of potentially hundreds of drugs, will challenge the storage capacity required for […]
Individualizing drug therapy based on pharmacogenomics (PGx) is considered by many academic researchers and clinical experts as the “next significant domain of clinical practice” (see the American College of Clinical Pharmacology’s very informative web-based tutorial, “The Future of Medicine: Pharmacogenomics”, http://user.accp1.org/index_new.html). Drugs that are currently recommended for PGx testing by the FDA include specific medications […]
An HHS committee on Physician and Patient Education is developing new certification requirements for hospital physicians in genomics and pharmacogenomics. Most hospital physicians, unless your specialty is oncology or obstetrics, are not familiar with anything but diseases inherited as classical Mendelien traits. These new rules will require basic certification in both classical genetics and the […]
