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Capitol Hill Event: Standards and Conformity Assessment Provide Vital Support to Smart Health Technologies


Experts from the standardization community shared insights on the various ways standards support intelligent healthcare systems at a recent Capitol Hill event organized by the American National Standards Institute (ANSI), the National Institute of Standards and Technology (NIST), and the Association for the Advancement of Medical Instrumentation (AAMI)the host organizations of the U.S. Celebration of World Standards Day 2017.

The event, titled "Smart Health: Using intelligent systems to improve the quality and delivery of healthcare in a more integrated, focused approach," brought together over 40 stakeholders to discuss the latest advancements in intelligent healthcare systems.

ANSI president and CEO S. Joe Bhatia opened the session by emphasizing how thousands of U.S. and international standards support smart healthcare technologies. He noted how standards and conformity assessment help ensure processes and products that support smart healthcare are safe, reliable, and efficient.

Bhatia also emphasized the importance of public-private partnerships for standards development a process that is primarily voluntary, private-sector led, and marketplace driven.

"All of these smart health technologies, services, and systems are able to work together and perform as intended, safely and reliably, because of the thousands of standards and codes developed by experts across every technology area," he said. "And those experts come from all backgrounds. Some are government employees. Some work for manufacturers or other companies, and some represent trade associations or consumer groups. The important thing is that they all work togetherin a collaborative, consensus driven environmentto produce the best possible standards."

Matthew T. Clark, Ph.D., chief science officer, Advanced Medical Predictive Devices, Diagnostics, and Displays, Inc. (AMP 3D), gave attendees a better picture of how smart healthcare has evolved, noting how medical practitioners can use technology to predict and prevent deadly illnesses. The company's Software as a Service (SaaS) platform for predictive analytics processes "big" physiological monitoring Data in real time andat a glanceenables proactive intervention for patients, as young as newborns.

Janet Marchibroda, executive director, CEO Council on Health and Innovation at the Bipartisan Policy Center, also spoke on behalf of standards supporting areas in need of growth in healthcare, such as electronic health records, and highlighted why interoperability and information sharing are important. Clinicians and care teams, for example, need access to informationregardless of where care has been deliveredto inform clinical decision-making and coordinated care.

To that end, she noted that health IT improves patient safety, but if it is not well designed or implemented, it may cause harmand standards play a critical role in facilitating safety and interoperability.

Marchibroda and Kevin Fu, associate professor, computer science and engineering director, Archimedes Center for Medical Device Security, University of Michigan, and co-founder and chief scientist, Virta Laboratories, Inc., both noted the dangers of cyber threats on the rise, as increasing connectedness between medical devices and other digital technology creates more risk.

While the benefits of these technologies greatly outweigh the risks, Marchibroda added that addressing cybersecurity issues is a shared responsibility among industry, providers, and individuals. Ultimately these issues underscore the need for industry to collaborate to develop and drive the adoption of common industry standards and to facilitate information sharing and drive the adoption of best practices.

Fu also noted the dangers of software update failures, and the patient impact.

AAMI president and CEO Robert Jensen recognized the collaborative element of smart health standards development, adding: "Standards can be dry and technical documents, but they are really all about people," he said. "At AAMI, they are about the innovators who design and develop cutting-edge medical devices; the regulators who review applications for new devices; the doctors and nurses who use them; the professionals who service and support the devices; and, most of all, the patients who benefit from them."

Pictures from the event are available.

For more about this, see ANSI's coverage: Standards Community to Host Hill Event on Smart Health


Jana Zabinski

Senior Director, Communications & Public Relations


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Beth Goodbaum

Journalist/Communications Specialist


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