Regulations, Genetic Workflow, and Privacy: Coming Challenges for Health-IT

By Allison Proffitt

April 9, 2013 | The keynote session at the inaugural Medical Informatics World Conference in Boston yesterday kicked off conversations on a broad range of health-IT challenges: everything from Meaningful Use Stage 2 to the coming surge of clinical genomics.

One of John Halamka's favorite medical codes is for a patient "bitten by turtle in squash court," but coding such events only begins to describe the challenges on the horizon for health care and health-IT.

The CIO of Beth Israel Deaconess Medical Center started the conversation at Medical Informatics World by summarizing some of the major changes looming the horizon for health care: big data; health care information exchange; security and privacy issues; clinical decision support; data sharing, sometimes between competitors; and patient and family involvement.

The goal, Halamka says, is to get it all right: the right test for the right patient and the right treatment in the right environment at the right time.

First, there are the mounting size issues. Halamka's group manages 3 petabytes of data, and while saying that "a team of expert analysts is available" sounds good, Halamka says data analysis now needs to be real time and self service. Beth-Israel has developed “Informatics for Integrating Biology and the Bedside”——a Web-based, open source, drag and drop platform for analysis of de-identified data. It's the kind of thing that researchers and clinicians are demanding, he says.

At Beth-Israel, 30% of Halamka's budget is now going to compliance and regulatory imperatives. Among the coming regulations, Meaningful Use Stage 2 requires 5% of patients to actually use tools in order for doctors to be paid. At Beth-Israel, Halamka says, that means a concerted effort to develop mobile applications. The group is launching its smart phone app for medical records next week.

And then there are the security issues. "At the same time that I'm sharing more data with more people for more purposes, I have to keep everything completely secure and private," Halamka points out.

A security breach can cost $500,000 in breach reporting expenses. "I am responsible for the security of every byte that flows through the system," he says. Sometimes that means limiting access to data from off site. Sometimes it means manually encrypting 7,000 cell phones.

"The next few years are going to be the busiest of my career," Halamka says, "but it's also the opportunity to do the most good."

Genetic Integration

Sandy Aronson, Executive Director, IT, Partners HealthCare Center for Personalized Genetic Medicine, agrees that now is a turning point for health care—a time of the greatest challenges, but also the greatest opportunities. Progress will require much of society's resources as we call for an evolution of the regulatory framework, the IT framework, and require buy-in from all stakeholders, including patients.

The development of genomics in the clinic is poised to be the greatest driver of change in health care. There must be IT infrastructure that can be pre-positioned to take advantage of genetics discoveries as they are made, Aronson said. He and his team have developed the GeneInsight suite to manage the integration.

GeneInsight Clinical interface is designed for use by clinicians and is integrated with the EHR. The system logs a patient's genetic data and when the research on a particular variant changes. Say a new study shows that a variant is associated with pathogenicity, GeneInsight alerts the physician that there is new, important health information for the patient.

The tens of thousands of variants in the system are always in flux. "You have this data model constantly being fed, constantly being refined," Aronson says. Add to this family data, imaging data, patient phenotype, and all of a patient's other variants and the data size quickly becomes overwhelming.

The only solution, Aronson says, is "highly structured crowd-sourcing."

GeneInsight Clinic is backed up by the much larger GeneInsight Lab. The goal of the infrastructure is to not only move data to the clinic, but knowledge as well, so that clinicians can draw on all the knowledge in GeneInsight Lab*.

"The integration that happens here is not just transactional. It's not just reports that are passed from the laboratory to the clinic, but it's actually knowledge that passes from the laboratory to the clinic to keep clinicians up to date."

The Other Species

But health care isn't about serving some "other species", pointed out Mark Davies, Executive Medical Director, Health & Social Care Information Centre, at the UK's National Health Service. We are the patients, and the public is the most underutilized resource in health care.

A connected health care system is not just about the clinicians, the IT infrastructure, and the data, but also about the patients' inputs—their hopes and indications and fears and insights into their own diseases. A connected health system must be patient centric, said Lonny Reisman, Aetna's CMO.

Aetna did an experiment, eliminating drug co-pays for heart attack patients in hopes of increasing compliance. It made a difference, Reisman said, but the trial still couldn't get more than 50% compliance. That must change for outcomes to change.

"We are unlikely to meet the sustainability challenge if we [as patients] continue to be passive consumers," Mark Davies said. "We must be active consumers and experts in our condition, compliance, treatment, etc."

When both privacy and engagement are crucial, we walk a fine technological line. Aetna has developed or acquired technologies to give patients insight into their health observations that have been made, Reisman says, but privacy is still paramount.

Aronson raises the bar even further. As sequencing becomes more common--he expects babies to be sequenced at birth in ten years—health care delivery and privacy are family questions. "It's just a matter of more detailed regulatory frameworks," Aronson says. "I think there are reasons to be optimistic."

*Aronson will speak more about GeneInsight Lab on Wednesday, April 10 at 11:00 at a session at Bio-IT World. For more information, visit


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