糖心vlog

The health care industry has experienced rising costs coupled with over 20 years of near-zero labor productivity growth.¹ Recent innovations such as the electronic health record (EHR) displayed initial promise by digitizing the paper chart, but data structures and the manual nature of data acquisition have remained unchanged. Current policy efforts focus on centralized data sharing between EHRs, often overlooking distributed data鈥攁nd the need for standards to retrieve it鈥攊n many medical devices. We review previous interoperability efforts centered on EHRs, draw lessons from the telecommunications industry in standard settings, and identify opportunities for and benefits of standard setting to promote interoperability in the medical device industry.

Much of the existing infrastructure for health care interoperability has focused on EHRs. Created through a federal executive order and solidified in statute via the Health Information Technology for Economic and Clinical Health Act, the Office of the National Coordinator (ONC) for Health Information Technology is charged with promoting the interoperability of clinical data repositories and registries. The Office of the National Coordinator has largely incorporated industry-driven interoperability frameworks including Health Level Seven International鈥檚 Fast Healthcare Interoperability Resources (FHIR). The Office of the National Coordinator mandated the adoption of FHIR in its implementation of the 21st Century Cures Act,² as did the Centers for Medicare & Medicaid Services (CMS) through their 2020 Interoperability Final Rule.³

Nonetheless, full EHR interoperability faces a number of practical obstacles. First, the financial costs of consolidating platforms are substantial, particularly for large health care systems that may rely on over a dozen incongruous EHR vendors across disparate clinical settings for functions as varied as radiology, inventory management, and pharmacy, in addition to the physician-facing record. Second, medical records are notoriously balkanized in EHR frameworks, wherein a patient鈥檚 health information may be spread across wearable devices used in the home, outpatient clinics, and hospital care resulting in any 1 clinician seeing only a portion of a patient鈥檚 full picture of health or illness. Incongruous patient identification standards pose real challenges to interoperability. Even if all systems relied on FHIR, matching patients within these systems would remain an error-prone and labor-intensive endeavor. Finally, FHIR does not address the need for standards for identifying the medical device product class or functionality in a decentralized, networked clinical environment encompassing homes as well as hospitals and other clinical settings.

Offering lessons for health care delivery, consumer and enterprise information technology markets could not exist without interoperability standards. Bluetooth and USB specifications ensure that keyboards, web cameras, and headphones work with just about any computer without the need to download special software. Every mobile computer or phone can connect to every home Wi-Fi network, even though they are likely manufactured by different vendors. Phone calls and text messages work across different carriers and generations of technology, allowing a single smartphone to work around the world and use 1 web browser for all web pages. Ongoing standards development efforts will integrate sensors and actuators made by different vendors into the Internet of Things (IoT) for smart homes, energy management in buildings, or intelligent transportation systems.

Standardization offers a host of benefits to consumers, industry, and the public sector. Vendors compete on the basis of features useful to the consumer, rather than mutually incompatible frameworks. Interoperability creates an ecosystem to develop downstream products, such as Wi-Fi, Bluetooth, and USB, and encourages well-vetted security standards. Interoperability also has simplified training for users and developers. When the telecommunications industry has failed to develop standards, the federal government has stepped in to facilitate industry actors, with standards development in broadcast digital television widely recognized as a successful recent example.

Medical devices鈥攊n health care settings as well as those worn by patients鈥攁re increasingly network connected. They can enhance clinician productivity and satisfaction by automating manual record-keeping tasks. By rendering clinically relevant information available at clinicians鈥� fingertips in nearly real time, interoperable networked devices could yield dividends in quality, safety, and operational efficiency.

For example, in the intensive care unit a combination of networked ventilators, pulse oximeters, and telemetry monitors could provide real-time, targeted alerts to a clinician鈥檚 smartphone warning of a rapidly deteriorating patient, a task currently requiring a clinician at the bedside, or alternatively combat alarm fatigue to discern meaningful alarms requiring intervention. For the hospitalized patient with heart failure, networked scales and Foley catheters could automate the manual tasks of tracking weight and urine output, the latter an hourly task. For clinical research, interoperable, networked devices may make it easier to collect patient-derived data and support its integration into medical records, helping transition clinical trials from specialized study sites into the home and community settings, and assist with the recruitment of more diverse study populations. Interoperable devices could further lower the cost of developing medical devices and new therapeutics by simplifying data acquisition in community-based trials, in addition to improving patient safety by reducing human errors from manual data entry.⁴

Medical device data, however, are currently fragmented by device type, ranging from consumer health applications to wearables, ambulance-mounted equipment, and both moveable and stationary devices in clinical settings. This fragmentation underscores the need to facilitate seamless interfacing by providing common language, protocols, principles, and ground rules. The European Commission has sought to promote broad harmonization by formally requesting standards development organizations to promulgate medical device standards.⁵

The US Food and Drug Administration (FDA) indirectly supports the development of consensus standards^6,7 through its Standards and Conformity Assessment Program.⁸ To support regulatory decision-making, a consensus standard itself, device interoperability frameworks would need to address common elements such as a device identity and communication standards, while also recognizing that device identity standards will differ substantially across device classes, thus accounting for the wide range of technologies supporting patients from automated blood pressure cuffs to ventilators and the varying technical complexity required to produce them.

Establishment of a standards development organization presents an opportunity for public-private partnership. It would require technical and systems expertise, relying on industry participation through both convening and standards development organizations such as the Medical Device Innovation Consortium, Association for the Advancement of Medical Instrumentation, and the American National Standards Institute. Rather than invent new IoT-specific standards, existing interoperability efforts and security standards (eg, HTTPS, W3C, Web of Things) could be retooled to accommodate the specific functions of medical devices and address cybersecurity concerns. This approach from the ground up would avert many of the implementation challenges facing EHR interoperability because it extends far beyond FHIR鈥檚 narrow focus on data exchange formats alone. The FDA should encourage the development of an industry-wide medical IoT harmonization initiative, be it within an existing organization or one formed for the task. Furthermore, a new FDA digital health advisory committee could facilitate private sector coordination and gather stakeholder input.

Medical device interoperability can improve health care by enhancing productivity with actionable data, but only if standardization allows data to flow across a wide range of devices and applications. The FDA is well positioned to promote medical device interoperability by supporting the development of an industry driven, third-party standards development organization. By fostering research and development, improving clinical efficiency, promoting a cybersecure framework for data-sharing, and enhancing national competitiveness in the global marketplace, standards will help medical device interoperability realize its full potential, benefiting both patients and clinicians.

Published: January 14, 2022. doi:10.1001/jamahealthforum.2021.4313

Open Access: This is an open access article distributed under the terms of the CC-BY License. 漏 2022 Gowda V et al. JAMA Health Forum.

Corresponding Author: Brian J. Miller, MD, MBA, MPH, The Johns Hopkins Hospital, 600 N Wolfe St, Meyer 8-143, Baltimore, MD 21287 (brian@brianjmillermd.com).

Conflict of Interest Disclosures: Dr Schulzrinne worked at the Federal Communications Commission from 2010 through 2017, including as Chief Technology Officer from 2012 to 2014 and in 2017. Dr Miller previously served as a Senior Policy Fellow for Health IT at the Federal Communications Commission in 2015 and as a medical officer at the U.S. Food and Drug Administration from 2016 to 2017. He also reports serving as a member of the CMS Medicare Evidence Development and Coverage Advisory Committee and receiving fees outside the related work from the Federal Trade Commission, the Health Resources and Services Administration, Oxidien Pharmaceuticals, and the Heritage Foundation. Mr Gowda reports receiving fees outside the related work from Give Legacy, Inc; a fertility preservation startup.