Interoperability and User-Friendliness Key to the Future of Health IT

Interoperability, interoperability, interoperability. On Tuesday Oct. 2 at AdvaMed 2012, the panel discussing the impact of health IT regulations on industry could not stress the importance of interoperability in health IT enough.

Convened to discuss the future of heath IT were Shami Feinglass, M.D., (who acted as moderator), a former regulator and lobbyist, now vice president of global medical affairs and regulatory policy at Zimmer Inc.; Patricia Katzman, director of interoperability and clinical decision support for Philips Healthcare’s patient care and clinical informatics business; Anna McCollister-Slipp, co-founder of Galileo Analytics, member of an advisory board to the Center for Devices and Radiological Health within the U.S. Food and Drug Administration (FDA), and patient advocate; and Robert Jarrin, senior director of government affairs at Qualcomm.

According to the Office of the National Coordinator (ONC) for Health IT, a department within the U.S. Department of Health and Human Services, health IT makes it possible for healthcare providers to better manage patient care through secure use and sharing of health information. Health IT includes the use of electronic health records (EHRs) instead of paper medical records to maintain people’s health information.

McCollister-Slipp began the conversation by describing her personal experience with type I diabetes, which she has been living with for 27 years. At any given time, she could have up to four different devices on her person tracking glucose and other substance levels in her blood, and other devices relating to various complications with her disease. Advocating for more patient empowerment, McCollister-Slipp insisted that data, whether it be EHRs or real-time monitoring data, should be much more freely available to patients.

“There is so much patronization of patients,” McCollister-Slipp said. “There is the attitude that they will be overwhelmed and unable to understand [data and information]. But look—I don’t know anything about cars, but if I have to spend $60,000 on one, I will engage, learn, and make the right decision. Patients learn and patients care in the same way.”

She recalled “e-patient Dave.” David deBronkart was diagnosed in January 2007 with stage IV, grade 4 renal cell carcinoma (kidney cancer) at a very late stage. His median survival time at diagnosis was just 24 weeks. Now a cancer survivor and motivational speaker, he often displays 3-D images of his tumor at speaking engagements, visually explaining how it began, how it shrunk, and its characteristics.

“He saw and understood the cancer, and that was very important for him to get his head around the disease,” explained McCollister-Slipp.

But, as an audience member asked, interoperability with what? There has to be a backbone on which the data rests. Who will build, own, and regulate the data and the systems that house the data?

“Some would argue that that’s what the ONC is doing,” said Jarrin. The ONC is working on several initiatives in the health IT space, including cybersecurity, rural health IT, and a nationwide health information network. “Others,” continued Jarrin, “would argue that there is already existing [data] cloud that anyone can access, and that it’s more an issue of security.”

The issue of who owns data can become very complicated. For instance, Katzman pointed out that while hospitals don’t share data very much with each other, they each have a huge network of their own. The goal of those who work in health IT, she said, is to make one worldwide network. “Imagine what kind of progress we could make, the products we could develop from that wealth of data.”

And is a patient’s health information her own property, the property of the device maker that records that data, or of the physicians and hospitals that interpret and house the data? The fact that there is no easy answer to that question is what fuels the debate surrounding health IT.

Speaking of ownership, most everyone now owns a mobile device. “Mobile telephony is the most important technology we have now,” said Jarrin. “Everything is done through it. Everyone has it. Yet we have very sick people. According to the Center[s] for Disease Control [and Prevention], half of all people now have a chronic disease, and its getting worse.”

Jarrin’s statistic is correct. As of 2005, almost one in two American adults had at least one chronic disease.

What if we could harness mobile telephony, wondered Jarrin. As the panel joked that Apple computer founder Steve Jobs’s mistake was never registering the iPad as a medical device, Jarrin pointed out how close the device got to being regulated by the FDA.

“Steve Jobs held up an iPad and showed an ECG [electrocardiography] wave form, which caught the attention of federal regulators. Intended use is important. It goes beyond what you say about what the device is for. The act of showing ECG on an iPad could make it a medical device. It can be loaded with medical device software.”

This touched on McCollister-Slipp’s point of putting control in the hands of patients, and trusting them to take charge of their own health to an extent. She encouraged device makers in attendance to divorce themselves from the notion of making devices and technology always geared to a specific use. Like the iPad, there are technologies that could and should be user-friendly (read: easy for the layperson or patient to use) and open to a variety of uses.

“Don’t assume that you know what people are going to do with your data,” said McCollister-Slipp. “There are smart people out there, they will think of creative ways to use the data that others wouldn’t have.”

Despite Jarrin pointing out how hard a line it is to walk—no one wants patients taking diagnosis totally into their own hands—McCollister-Slipp stayed true to her conviction.

“Yes, not everyone will be able to handle information perfectly, but they may not even handle information that comes straight from the doctor perfectly,” she said. “It’s not our role as the manufacturer to figure out what’s OK or not [in terms of data access]. We have to think of the many ways in which people can use data.”