FDA Policy/General

FDA, IBM Open Health Data Exchange Project

FDA and IBM Watson Health have agreed on a two-year research initiative to define a secure, efficient, and scalable exchange of healthcare data using blockchain technology. An IBM statement says that the two parties will explore the exchange of owner-mediated data from several sources such as electronic medical records, clinical trials, genomic data, and health data from mobile devices, wearables, and the “Internet of Things.” An initial focus will be on oncology-related data.

Blockchain technology, IBM says, enables organizations to work together with more trust. By keeping an audit trail of all transactions on an unalterable distributed ledger, the technology is said to establish accountability and transparency in the data exchange process. “In the past,” the statement says, “large-scale sharing of health data has been limited by concerns of data security and breaches of patient privacy during the data exchange process.”

FDA and IBM say they will explore how a blockchain framework can potentially provide benefits to public health by supporting important use cases for information exchange across a wide variety of data types, including clinical trials and “real world” evidence data. The collaboration is also to address new ways to leverage the large volumes of diverse data in the biomedical and healthcare industries. “A secure, owner-mediated data sharing ecosystem could potentially hold the promise of new discoveries and improved public health,” the two say.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome