The FDA Put Interoperability on the Backburner, But the Industry Can’t
When the Food and Drug Administration issued its list of priorities for 2015, many were surprised to see that interoperability — a hot button issue when it comes to health IT — didn’t make the A-list. Instead, the FDA intends to focus on publishing guidelines for other aspects of health IT including wellness apps, device accessories and decision-support software related to medical devices.
In a January 2015 Modern Healthcare article, a lawyer representing industry groups concerned with health IT surmised that the FDA might be taking the back seat to allow other agencies to drive interoperability initiatives. Certainly, interoperability still needs to be a priority, particularly because as consumerism in health care strengthens, patients will expect providers to offer the same type of seamless experience they enjoy in other areas of their life.
Health App Developers Want FDA Guidance
Health app developers likely welcome the FDA’s plan to clarify guidelines surrounding wellness applications and accessories as the administration’s muddied rules related to marketing of health-related apps make developers nervous.
Take Modern Healthcare’s weight management app example. If the app were intended for personal tracking of weight for general health and well-being, the promotion of the app would not be regulated by the FDA. If, however, the developer were to market the app to a particular population segment — such as diabetics — as a tool for managing their chronic disease, different standards would apply. Similarly, developers would like more direction on “… when a general-use accessory — say, a cord connecting a device and a smartphone — requires strict FDA regulation.”
Yet app developers can no more afford to ignore the interoperability issue than others in the health care industry can. After all, consumers will ultimately want to synchronize the data they collect in their personal health apps with their EHRs so that all personal health information is available to providers.
Demand for Interoperability Generates New Alliances
The JASON group, the independent scientists that advise the U.S. government on science and technology, tackled the subject of the country’s health data infrastructure — which as we all know is woefully inadequate — and made a number of recommendations. One of the most exciting responses to the call to action has been the health care industry’s commitment to action.
In response to the recommendation of the JASON group to develop “a new ‘architecture’ for health information exchange based on application programming interfaces (APIs)” commonly used by developers for other industries, EHR system developers and health care leaders have stepped up to the plate. At the opening of HL7’s Policy Conference held in Washington, D.C. on December 4, the Argonaut Project, an alliance of health care organizations from across the United States, was announced:
- Beth Israel Deaconess Medical Center
- Intermountain Healthcare
- Mayo Clinic
- Partners HealthCare System
- SMART at the Boston Children’s Hospital Informatics Program
Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center told Modern Healthcare, “It brings Facebook-, Google- and Amazon-like thinking to health care IT.” The goal is to develop a health care IT platform that functions much like developer platforms for smartphones and tablets.
By collaborating together to develop the standards and implementation guide, the Argonaut Project will create an environment where developers can make the health IT products that consumerism in health care demands. The question remains, if you build it, will they come?
In order to design products and services that consumers want, developers, health care providers, insurers and other health care-related enterprises need deep insights into the consumers themselves. With consumer segmentation, including classifications based on psychographic segments, organizations can fine-tune solutions to target patients with greater precision — and effectiveness. Overlooking consumers’ personal motivations for healthy behavior change may mean that millions of dollars in infrastructure and systems investment is wasted.