GE Healthcare and Roche entered into a strategic partnership to co-develop and co-market digital clinical decision support (CDS) solutions. GE Healthcare is a worldwide leader in medical imaging equipment, while Roche Diagnostics is the global leader in in-vitro diagnostics. The partnership will initially focus on products that accelerate and improve individualized treatment options for cancer and critical care patients.
The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.
For example, oncology care teams with multiple specialists will have a full data dashboard to help them collaborate on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, tissue pathology, genomic and sequencing data. Physicians will be able to identify, or even predict severe complications before they strike.
According to FierceBiotech, GE chief innovation officer Nadeem Ishaque cites the bringing together of diagnostic images, pathology and genomic information for a breast cancer patient as an example of the potential of the collaboration. Ishaque stated, “By leveraging this combined data set using machine learning and deep learning, it may be possible in the future to reduce the number of unnecessary biopsies that are performed due to suspicious findings in the mammograms and possibly also reduce mastectomies that are performed to combat ductal carcinoma in situ, a condition that may evolve into invasive breast cancer in some cases.”
The strategic partnership will have to navigate the new FDA guidance on CDS solutions. Some types of CDS will no longer be defined as a medical device and subsequently regulated by the FDA. Software that suggests a provider order liver function tests before starting statin medication is an example. However, the FDA will continue to enforce oversight of software programs intended to analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram. These programs use analytical functionalities to make treatment recommendations. Consequently, they remain medical devices under the Cures Act, because inaccurate information provided in the CDS has the potential for significant patient harm.
Many of the ideas driving the GE-Roche collaboration have been discussed for years, but action to date has not resulted in a noticeable reduction in healthcare inefficiencies and medical errors. With medical errors being the third leading cause of death in the U.S., an effective CDS solution by GE and Roche could have a significant impact.
“This is the first time that two major players in healthcare have combined advanced analytics with in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said GE Healthcare CEO Kieran Murphy in a recent press release.
As Murphy suggests, the potential for clinical decision support software success is there. We just need to see empirical evidence to show it.
(Photo: General Electric Logo, Flickr)