By Allison Proffitt
January 25, 2015 | The launch of the Precision Medicine Initiative last year continues to prompt questions and challenges in all areas of genomics and diagnostics, says Jonathan Sheldon, global vice president of healthcare for Oracle.
“Do we understand the financial impact of changing the clinical care pathway as a result of implementing a new genetic test?” he asks. On the security side: “We need to be much more realistic and honest about what is and isn’t possible in terms of the sort of security and privacy that [participants in the Precision Medicine Initiative] can expect.” And in terms of policies and interoperability: “Everybody is talking about big science and sharing data; it’s the hottest topic in the whole precision medicine space at the moment… But nobody really wants to share data either!”
In an effort to move forward on some of these questions, Oracle Health Sciences today announced Oracle Healthcare Precision Medicine, a software solution to connect genetic testing, report generation, and clinical care decision-making.
“One of the challenges in the marketplace is a vast majority of practicing clinicians, regardless of their specialty training, don’t understand genetic testing very much and the underlying mechanisms of it,” says Sean Sigmon, healthcare business development director at Oracle. “We think that enabling the pathology group, maybe the precision medicine council, there’s various groups within these institutions that are helping make these decisions. We have to facilitate that teamwork in order to have it scale and have consistent reporting.”
Oracle Healthcare Precision Medicine will serve as a technical framework for delivering individual diagnostic reports, linking the researcher uncovering biomarkers, the molecular pathologist identifying the actionable biomarkers for a given condition, and the clinician evaluating the resulting data and advising on treatment plans for patients.
Until now, lack of traceability, scalability, and data security, combined with siloed tools, disparate terminologies, and varied workflows have all kept these team members from collaborating on the best therapy for the patient, the company believes.
Oracle Healthcare Precision Medicine addresses the data aggregation, knowledge exchange, normalization, and workflow issues that restrict the timely creation of patient molecular profiles. The new solution allows a wide range of experts to conduct seamless collaborations on ‘best treatment’ plans for individual patients.
The new solution is meant to address a shift Oracle Healthcare sees in the market, explains Sheldon. We are moving from research to applied genomics, he says, bringing the science to bear on clinical care pathways.
“But what comes with that is a different kind of IT system, because it’s part of clinical decision making,” Sheldon tells Diagnostics World. “A lot of the systems that grew up in the Precision Medicine Initiative era came from what needs to happen in research, but I think that’s different from what needs to happen in clinical care—things like scalability, security, and software development lifecycles.”
The questions, Sheldon emphasizes, are bigger now. Patients have not just genomic data, but also clinical data, wearables data, lifestyle data, and even social media activity. “There’s a huge amount of data now that kind of sits around the patient,” he says, “which is just as important as the genomic data. From an IT systems perspective, you have to look at all of those source systems.”
For payers and providers, there are additional financial questions that warrant study. “There’s an opportunity to combine the genotypic and clinical data and then ultimately understand the financial impact of these approaches and therapies,” adds Sigmon. “Those [research efforts] also need to be institutional-grade, because there’s a lot of pressure in the healthcare system to make this viable over time.”
What’s needed, Sheldon says, is enterprise-grade mission critical scalable infrastructure. He highlights a few characteristics he believes the industry should focus on: APIs and interoperability; consistent terminologies to describe data; new standards around capturing clinically-actionable information; scalability, traceability, and auditability of solutions; and integration with the EMR to get data back in front of the physician.
Oracle won’t check all of those boxes, but Sheldon believes that Oracle does provide a “strong, underlying foundation that integrates clinical data and genomic data.” Oracle Healthcare Precision Medicine will be very open and will support APIs, Sheldon says, so that “our partners can get at the data as well, and they can do all they want to do securely.”