Articles and Blogs

On February 6, the Food and Drug Administration (the “FDA” or “Agency”) released a finalized guidance (the “Guidance”) informing the public that the Agency does not intend to enforce any regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data, specifically including medical image storage (“MIS”)... READ MORE

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and... READ MORE

Three federal regulators have released a long-awaited report proposing the framework for regulation of health information technology (“Health IT”).  The U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) are accepting comments on their proposed risk-based regulatory framework until July... READ MORE

The U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) are accepting comments on their recently issued final FDASIA Health IT Report, entitled Proposed Strategy and Recommendations for a Risk-Based Framework. The agencies are seeking public comment on the questions... READ MORE

 On April 3, 2014, the U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) released their long-awaited final report on health information technology (“Health IT”), entitled Proposed Strategy and Recommendations for a Risk-Based Framework. According to the report, the degree... READ MORE

On March 12, the Federal Trade Commission (“FTC”) published new guidance detailing how advertising disclosures should be made online.  Disclosures are necessary to qualify or limit advertising claims that would otherwise be deceptive, unfair or give misleading impressions. READ MORE

The Food and Drug Administration (“FDA”) is seeking comments on a draft guidance entitled “Design Considerations for Devices Intended for Home Use.”  The draft guidance urges manufacturers to “design out” product risks and consider usability and training for medical devices intended for use in a home environment.  The deadline for submitting comments on the... READ MORE

ECRI Institute has released its list of the Top 10 Health Technology Hazards for 2013.  The annual report is based on the prevalence and severity of incidents reported by health care facilities and information found in the Institute’s medical device problem reporting databases. READ MORE

On November 30, 2011, Daniel R. Levinson, Inspector General, appeared before the Special Committee on Aging, and testified regarding the Office of Inspector General’s (OIG) findings pertaining to the use of atypical antipsychotic drugs by nursing home residents. The OIG hired psychiatrists who are experts in treating elderly patients to review a sample of... READ MORE