This week’s digital health news…
FDA Finalizes new Medical Device Clearance Guidelines
The FDA released a finalized version of its 510(k) process a premarket submission made to demonstrate the safety and effectiveness of a medical device. The previous version required the testing of new device against what was already available on the market. The update now allows new technology to be measured against a set of “objective, transparent and well-validated safety and performance metrics.” In a publicly released statement, FDA Commissioner Scott Gottlieb asserted: “The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products.” Officials also noted that the new approach may “drive greater market competition to develop safer devices.”
Leading Tech Companies Release Applications for Women-Focused Health Tech Entrepreneurs
The Women and Access to Health Daring Circle — a health partnership forum consisting of Google, Sanofi, BNP, and others — has announced an open call for applications from start-ups aimed at improving access to healthcare for women. Winners will receive six months of mentorship, an undisclosed amount of funding, media exposure, and numerous networking opportunities. In the announcement, The Daring Circle identified six key categories “of barriers to safe and quality care for women based on their potential to be addressed by tech-led solutions.”: lack of health care providers informed by sex-disaggregated research, barriers to accessing mental health care, limited awareness and access to information, limited physical access to care, lack of confidential or reliable health records, and lack of means to pay or time-poverty. The deadline for applications is February 15, 2019.
Vanderbilt Develops EHR Voice Assistant
Vanderbilt University Medical Center has developed a voice assistant for electronic health records capable of interpreting voice requests and providing verbal summaries. EHR processes have been a consistent source of provider fatigue and burnout. Vanderbilt’s new design aims to streamline the often complex EHR process in an effort to supply providers with more time with patients. In a publicly released announcement, Dr. Yaa Kumah-Crystal — core design advisor at Vanderbilt Medical Center — stated: “I would encourage healthcare CIOs to invest in research and platforms that can allow their providers to use their voice to find the information they seek and empower patients to engage with their health. Healthcare is always so far behind with technology, and this is an opportunity for us to be at the forefront. Voice user interfaces are an essential step to humanizing the EHR.” Vanderbilt is consulting with healthcare software giant, Epic Systems Corporation to improve EHR capabilities.
U.S. Hospital Associations Call for Progress on Interoperability
Seven leading U.S. hospital associations have released a joint report urging stakeholders to accelerate towards towards interoperability in health information technology. The report, Sharing Data, Saving Lives: The Hospital Agenda for Interoperability details benefits to interoperable technologies including strengthened care coordination, increased efficieny, reduced costs, and improved safety. In public statement, American Hospital Association President and CEO Rick Pollack stated: “We see interoperability in action all around us. Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions.” Included within the report are several pathways with which medical technology stakeholders can take to move towards interoperability.
Queensland Ambulance Service Launches New Emergency Digital System
The Queensland Ambulance Service (QAS) in Australia has launched SafeMate: a new digital health initiative aimed at providing paramedics with increased access to a patient’s medical information. The program is currently under trial with with select patients covered under Medibank, Australia’s second largest health insurance provider. In a public statement, Queensland Minister for Ambulance Services Steven Miles stated: “Paramedics will use their operational iPads to tap the patient’s SafeMate card or device, and the medical information will appear on the screen. It eliminates the time it would normally take a paramedic to ask the patient a range of questions in order to obtain their medical history and other pertinent details.”