Intel announced the launch of the Intel® Health Application Platform, software that, when coupled with an Intel-architecture-based design specification implemented by a third-party hardware vendor, can help enable healthcare solution providers to securely and reliably deliver distributed healthcare services and a new standard for remote patient care.
As digitization of healthcare systems progresses, more data about patients’ conditions are routinely captured and stored in digital format. These data come from many sources: clinical encounters with healthcare professionals, remotely captured in out-patient settings, disease registries, and claims. These data are already being used in numerous ways, to measure health outcomes and improve quality, for comparative effectiveness research or post-market surveillance of drugs and devices.
Two promising areas for real world health data are in the management of chronic conditions and generating evidence for drug approval. Remote patient monitoring (the ability to monitor patients’ medical conditions through ICT outside of traditional care settings) is an important tool for the acquisition of real world health data.
There is strong evidence that remote patient monitoring (RPM) is an effective patient-centered care model which offers better quality and health outcomes for patients and reduces costs from expensive hospitalizations. A review of decades of research by the Agency for Health Research and Quality (AHRQ) concludes that the most consistent benefit has been reported when telehealth is used for communication and counseling or remote monitoring in chronic conditions such as cardiovascular and respiratory disease, with improvements in outcomes such as mortality, quality of life, and reductions in hospital admissions.
Whilst Medicare coverage for remote patient monitoring is limited, there are signs that this may change. In a recent solicitation for comments on “CY 2018 Revisions to Payment Policies under the Physician Fee Schedule”, CMS asked for input on how to pay for remote patient monitoring and where it could be used. Equally significant was the approval by the American Medical Association (AMA) of new Current Procedural Terminology (CPT) billing codes for “Chronic Care Remote Physiologic Monitoring”. These, once valuated, would enter in use in 2019. These developments come with the potential that remote patient monitoring will become widespread in clinical practice in the next few years.
The interest in real world data to gather evidence in support of drug approval was recognized by the US Food & Drug Administration (FDA). The FDA is working on policies to support the use of real world evidence in the approval of new indications for already marketed drugs and to support post-approval drug study requirements. Clinical trials are a critical step of the drug approval process. They are expensive, complex and take on average nearly seven years. The recent trend towards precision medicine with more targeted treatments to the biological makeup of the patient brings new challenges to the Randomized Controlled Trial, the golden standard of evidence. As patient sub-populations become smaller, real world evidence can enable more efficient recruitment and facilitate adaptive drug approval by the close (remote) monitoring of patients.
It is alongside these exciting possibilities that Intel considers that the role of real world data has great potential for drug research and care delivery. The FDA should intensify its efforts to integrate real world evidence in the drug approval process. Remote patient monitoring provides patients with more convenience and reduces re-hospitalization. CMS should advance quickly to start paying for the new remote monitoring CPT codes.
It is for these reasons we are so excited to announce the release of the Intel® Health Application Platform, which helps enable solution providers to better connect patients and caregivers and capture and deliver the data they rely on for more personalized, data-driven healthcare.