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The use of mobile devices by health care professionals (HCPs) has transformed many aspects of clinical practice. Mobile devices have become commonplace in health care settings, leading to rapid growth in the development of medical software applications (apps) for these platforms. Numerous apps are now available to assist HCPs with many important tasks such as: information and time management; health record maintenance and access; communications and consulting; reference and information gathering; patient management and monitoring; clinical decision-making; and medical education and training.
Mobile medical apps provide many benefits for HCPs, perhaps most significantly increased access to point-of-care tools, which has been shown to support better clinical decision-making and improved patient outcomes. However, some HCPs remain reluctant to adopt their use. Despite the benefits they offer, better standards and validation practices regarding mobile medical apps need to be established to ensure the proper use and integration of these increasingly sophisticated tools into medical practice. Such measures will raise the barrier for entry into the medical app market, increasing the quality and safety of the apps currently available for use by Healthcare Providers.
Mobile Devices and Apps for Health Care Professionals: Uses and Benefits, C. Lee Ventola, MS.
The Impact of FDA Regulatory Approval
In 2014 government regulatory agencies began trying to regulate and curate apps, particularly medical apps. There has been growing concern about the emergence of untested apps to the extent that the FDA is now working to crack down on questionable healthcare apps. In addition, app makers will be required to provide additional disclosures about their software when asked to do so.
Understanding what triggers FDA oversight and the approval requirements will be key for a mobile app company’s success. The FDA is expected to issue additional guidance in 2015 clarifying which medical apps must obtain approval. Congress is debating whether to establish a more formal regulatory framework at the request of companies that want a risk-based regulatory framework.
Even more so, companies are being driven to design intelligent products armed with “diagnostic and treatment capabilities”, of which such features will certainly necessitate FDA regulatory review. NEXA’s assistance aims to ensure that such standards are achieved with the least amount of potential strain during the development process.
Regulatory approval may provide a competitive edge, setting one company apart from others in such a crowded field in the market. A particular study showed that 21% of healthcare providers surveyed said FDA approval was a necessity as it regarded their decisions to consider using particular medical apps.
Top Health Industry Issues of 2015: Outlines of a Market Emerge
NEXA’s aims to design client-driven custom medical software solutions through bi-directional communication between clients and our software development team. NEXA aims to assist with regulatory approval guidelines being upheld in addition to building confidence among healthcare professionals as it pertains to their overall satisfaction and decision to purchase.