It is tempting to want to purchase inexpensive, commercial off-the-shelf (COTS) tablets for use in medical facilities or to interface with medical equipment. Unfortunately, there are several technical, regulatory and security issues that could prevent you from doing that. Technical issues, FDA, and HIPAA security rules are just three potential pot holes for COTS tablets. Custom Android tablets for medical applications can be the answer and Modified-COTS custom tablets can get you to market quickly and with lower costs.
Medical Grade Tablet – Technical Issue
There are many unique devices in hospitals and doctor’s offices that a tablet could communicate with to facilitate the logging, processing, and management of data. Tablets are perfect for visualizing data, processing results and for sharing that data with patients or other medical personnel. Finding an off-the-shelf tablet that can seamlessly interface with various pieces of equipment may be impossible. Off-the-shelf tablets have other potential issues such as being too fragile for this environment, short product life-cycle, limited battery run-time, poor display readability in strong lighting or outdoor applications, as well as many others. Finally, the IT manager will want to control the tablet’s software to prevent unwarranted use or access. Access to the operating system may not be possible without voiding the warranty on a COTS tablet and some of the security requirements imposed on medical grade tablet may require just that.
FDA Certifications
If the tablet is going to be used in an application that requires FDA approval of the device, using a COTS tablet would become prohibitively costly. COTS tablet companies constantly change components, software and model numbers. Each change could require a recertification with FDA – a process that takes quite a long time and money. The FDA’s multi-step process for approval of Class I, II and III medical devices starts at product design and requires documentation throughout the development process. For Class II and III devices, strict manufacturing practices need to be followed and the device must be manufactured under the strict medical ISO 13485 in an approved manufacturing plant. COTS tablets are typically not built under this standard and the manufacturers do not provide the appropriate documentation and tracking necessary to meet FDA approval.
HIPAA Issues
HIPAA Title II establishes the policies and procedures for maintaining privacy and security of individually identifiable health information. Medical personnel can us a tablet to collect and display data, lab and test results, and personal information on an individual patient. In order to conform to HIPAA the tablet would need to be designed to meet the Security Rule to protect such data.
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