House releases draft of I.T. legislation
WASHINGTON Rep. John Dingell, D-Mich., chair of the House Energy and Commerce Committee, has released a discussion draft of proposed health care information technology legislation.
Provisions of the draft bill, which contains ideas from at least five House bills introduced during the last two congressional sessions, include the following:
Subject business associates directly to the safeguards in the Health Insurance Portability and Accountability Act privacy and security bills and hold business associates directly accountable to the federal government for violations of minimum contract requirements.
Close a HIPAA loophole that permits disclosure of protected health information for “treatment alternatives.” Authors of the legislation believe providers have used the loophole to send marketing materials to patients without their authorization.
Require regional health information organizations and health information exchanges to have business associate contracts under the privacy rule.
Require personal health record vendors who store the records in one place to notify consumers of data breaches.
Codify, or place into law, the Office of the National Coordinator for Health Information Technology. This would make the position permanent.
Establish two federal advisory committees to prioritize and develop technical data standards.
Establish and fund a health information technology resource center.
Establish grant programs to support provider adoption of I.T., support state-based I.T. loans for provider I.T. adoption, and support local and regional health information exchange initiatives. The discussion draft does not specify funding levels.
Takeda could see Alogliptin approval in near future
OSAKA, Japan Japanese pharmaceutical manufacturer Takeda’s new diabetes drug could get approval soon, according to Bloomberg.
According to the financial news agency, reports by analysts showed that the drug, alogliptin, had promise after the American Diabetes Association released parts of nine studies of the medication that were submitted for marketing approval in the U.S. in January, last week. They show the drug lowered blood sugar levels as much as Merck’s Januvia without serious side effects.
Alogliptin, also known as SYR-322, will compete with Merck’s Januvia and Novartis’ Galvus, which is also up for approval at the Food and Drug Administration. All three drugs are in a new class of diabetes treatments known as DPP4 inhibitors that signal the pancreas to produce more insulin and the liver to make less glucose, or blood sugar.
Assuming approval by the Food and Drug Administration, Alogliptin will succeed Actos, which generates about 29 percent of Takeda’s current revenue. Actos will lose patient approval in 2011.
Accutane ingredient linked to increased risk of depression
NEW YORK A study published in the Journal of Clinical Psychiatry has shown a link between use of the acne drug isotretinoin and increased risks of depression.
The drug was shown to more than double the risk of depression in a study of more than 30,000 people in Quebec who had received at least one prescription for it between 1984 and 2003.
Roche Pharmaceuticals’ drug Accutane has isotretinoin as its main active ingredient. The FDA originally granted approval to the drug in 1982.