The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are developed and designed to fit within the “connected health model” which attempts to provide flexible and efficient healthcare services by using connected technology that offers better communication, access and diagnostic capabilities. Many healthcare professionals use mobile apps for immediate communication with their patients and more responsive healthcare management. In a nutshell, there is a “mad dash” to address the demand of providing more “real time” health data. In response to this innovation, the question then becomes whether healthcare providers can tap into the available technology of “connectivity” and still protect health and personally identifiable information.
The U.S government has acknowledged the dilemma associated with medical apps and devices, when attempting to balance innovation with privacy and security. The Food and Drug Administration (FDA) over the past several years has instituted various initiatives to protect the public health from cybersecurity vulnerabilities of medical apps and devices. In particular, in late 2016 the FDA released final guidance, “Postmarket Management of Cybersecurity in Medical Devices,” which has been followed up with webinars and workshops to assist the public in guideline implementation. The FDA has also recently released its Medical Device Safety Action Plan which outlines the FDA’s plan to balance the security concerns associated with medical devices while still promoting innovation in this important field. In addition, the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, 45 C.F.R. §§ 164.302 – 318, requires covered entities to conduct a security risk assessment on medical devices and apps that contain electronic protected health information (ePHI) to determine cybersecurity vulnerabilities and deal with such as appropriate.
Discover what was found in a recent study conducted by the University of Piraeus by clicking below.