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The Easy and the Hard

EMBC15 participants had the opportunity to share their thoughts on the challenges of implementing standards during an LSTC-sponsored session.

International standards that are developed in an open and consensus ecosystem are the building blocks to validate, test, and assure the safety and performance of medical devices. Rapidly advancing innovations in information technology and telemedicine are continuously improving the level of healthcare worldwide, including quicker access to electronic medical records, real-time and continuous monitoring of patient vital information, improved clinical decision making, as well as data sharing and analytics for individuals and populations. While today’s standards may largely represent the current state of the art in a given biomedical field, there is a clear need to also develop standards for emerging biomedical and life sciences technologies. Standards-based solutions are necessary to build the technological foundations needed to foster and cultivate more biomedical technology innovations and to ensure new devices can reliably, safely, and economically connect to existing devices and systems. More importantly, industry-wide adoption of high-quality, consistent technical standards can allow patients’ and clinicians’ earlier, more equitable, and more affordable access to innovative devices that improve the quality and longevity of life.

However, such goals do not come without challenges. As part of the panel discussion on “Accelerating Biomedical Technologies Through Open Standards Development,” audience members were asked to weigh in on what they believed was both easy and difficult when it comes to standards implementation. Audience comments on what makes increased standardization easier include increasing consensus among diverse groups that interoperability and secure electronic records will dramatically improve healthcare cost, safety, and quality; acknowledgement that the process is becoming more streamlined with the aid of IEEE; and the fact that the data is already available. Others also noted that it is now easier to become involved in the development process as it is open to all, and some offered a reminder that any standards developments should remain patent-free.

As with many endeavors, difficulties appear when trying to change old habits and culture. These include moving manufacturers and clinicians away from the idea that information is proprietary or even getting them involved in the conversations about standards. There is also the cost of development and testing of new and small-scale devices to consider. Ultimately, it also comes down to having enough people available to safely reconfigure systems across platforms and the speed with which this might be accomplished.

In this same spirit, we invite you to share your thoughts and concerns regarding the challenges and opportunities of standards in health care. Send your comments to: and we will post these in an upcoming issue.

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September 2015 Contributors

Nirmal Keshava Nirmal Keshava is a Senior Principal Informatics Scientist at AstraZeneca, PLC in Waltham, MA, where he is leading efforts to use large-scale analytics to improve the cost and efficiency of drug development. Read more
Bill Ash Bill Ash is Strategic Program Manager for the IEEE Standards Association (IEEE-SA). He received his BSEE from Rutgers University School of the Engineering. His background is in the RF industry as he worked as applications engineer on wireless communications systems. Read more