Agency releases open source code and technical documents for new mobile app designed to gather real-time information about medication use and patient-reported outcomes; app will be incorporated into several PCORI-funded studies that FDA is leveraging as it explores the regulatory utility of real-world data.

Frustrated hospital executives are under increasing pressure to control the high cost of delivering care. As a result, they’re now using newly available data to evaluate certain medical products, especially high-end devices and implants for orthopedics and cardiology. Kaiser Permanente’s national Total Joint Replacement Registry, for example, works by having a number of interoperable systems feeding information into the database. The goal of the database is comprehensive, yet straightforward, with an emphasis on collecting details of failure rates, identifying patients at risk, identifying the most effective techniques and implant devices, tracking implant usage and costs, and monitoring and supporting recalls and advisories.

As patient safety emerges as a top priority in health care, there's been a steady stream of new regulations and heightened oversight designed to satisfy concerns that the right things are being done to ensure the safety of medical products. For medical device manufacturers, this atmosphere has intensified scrutiny of product design, a trend that could become even more acute later this year when the Association for the Advancement of Medical Instrumentation releases a new set of best practices for Human Factors engineering.