As reported in my January 24th, 2013 post, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued an omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). In addition to finalizing proposed regulations set forth in a proposed rule dated July 14, 2010, it also addressed other HIPAA provisions. It also finalized a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA). Continue reading this entry
Advances in information technology, such as high-performance computing, enables the collection, analysis and sharing of information between patients and medical providers. Computer technology makes possible the sequencing and analysis of huge data sets of genomic information. It also connects clinical and genomic information to support personalized health care. As a result, life science companies and health care providers are incorporating hardware and software into the delivery of healthcare and the management of patient information. These technologies are patentable as business methods, provided the technologies satisfy the criteria for patentability: patent-eligibility, novelty, non-obviousness and adequacy of disclosure.Continue reading this entry
The collection, analysis and sharing of digitized information between patients and medical providers is promising to revolutionize the doctor-patient relationship. This new paradigm is enabled through recent innovations in information technology (“IT”), i.e., software, hardware, wireless access and mobile communications, rather than by the delivery of traditional health care such as pharmacology and biotechnology. New information- and communication-enabled applications are personalizing health care, increasing its effectiveness and reducing its cost. This article will review this emerging field of IT-enabled health care and discuss challenges to its wide-spread adoption in the United States.Continue reading this entry
The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s full potential and benefits. This post summarizes the Coalition’s view of the state of the industry and the issues identified as critical to the ongoing development and adoption of personalized medicine.
On October 14, 2011 during Foley & Lardner’s life sciences conference “Winning Strategies: How to Create, Grow and Sustain a Successful Life Sciences Company”, I hosted a panel of industry experts speaking to the challenges and opportunities in realizing the promise of personalized medicine. While much progress has been made in removing legal, technical and regulatory barriers to making personalized medicine widely available to American citizens, much work needs to be done. Our panel comprised of Ken Goldman, Suneel Ratan and Anita Chawla, Ph.D., looked at those challenges and commented on the promise of personalized medicine. Copies of their presentations are provided here.
Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual. Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease. In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the individual’s disease risk so that a healthcare strategy can be implemented that focuses on prevention or early intervention rather than a reaction to an advanced stage of disease.