Mobile healthcare, telemedicine, telehealth, BYOD


How the FDA is Transforming Patient Engagement Policies

By Vera Gruessner

- The healthcare industry is truly focused on direct patient care and ensuring that families, caregivers, and patients are satisfied with the services of the medical field. As such, patient engagement plays an imperative role in ensuring the health, happiness, and overall wellness of each individual is boosted throughout the healthcare spectrum.

Patient Engagement Protocols

The Food and Drug Administration (FDA) is also taking part in ensuring patient engagement is secured and optimized throughout the healthcare field. In an FDA Voice blog post, Dr. Nina L. Hunter and Dr. Robert M. Califf wrote about a patient advisory committee established by the organization.

Often, medical technologies like remote monitoring equipment, mobile health apps, and even telemedicine services are based on the expert opinions of medical professionals instead of relying on consumer expectations. This may actually lower patient engagement outcomes if the needs of the consumer are not addressed with the implementation of new technology.

Patient-centered decision-making is becoming a priority for the healthcare industry, the FDA blog post explains. Along with the help of physicians, nurses, and other medical professionals, patients and their caregivers are actively taking part in clinical decision-making.

More consumers of healthcare are now making their own choices in regards to their diagnostics, treatments, and medical care instead of having doctors make all of the decisions for them. The FDA supports the idea of patient engagement and how it can help bring more positive patient experiences throughout the healthcare spectrum.

The FDA brings to the forefront its very first Patient Engagement Advisory Committee (PEAC). This type of committee will offer more guidance on medical devices, the regulation of these tools, and patients’ use of medical devices. The FDA will then learn more about patient-related topics in regards to medical technologies with the help of this patient engagement advisory.

“The PEAC represents a new and exciting opportunity to foster patient partnerships with FDA, and it complements other efforts at FDA to bring the patient into the medical device regulatory process. This includes studies to evaluate patient preferences in medical devices and a recently published draft guidance on patient preference information for PMAs, HDE applications, de novo requests, and inclusion in device labeling that describes how patient tolerance for risk and perspective on benefit, in addition to clinical data and other information, may be considered in FDA’s assessment of the benefit-risk profile of certain devices,” the FDA Voice blog post reported.

This type of insight into the patient perspective could offer more information on the risks and benefits of medical devices with regard to the consumer’s apprehensions. This committee would also offer insight into how patient perspectives differ across populations.

As the FDA focuses on patient-centered medical device development, the healthcare industry will likely benefit from greater patient engagement on that particular side of medical technology creation. The committee will focus on regulation and policy surrounding medical devices as well as patient preference design.

Patient engagement will likely continue to be a major topic among medical professionals and time will show whether the quality of care and health outcomes improve with the adoption of patient engagement protocols.


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