The Food and Drugs Authority (FDA) has recently issued the draft guidance document for mobile medical applications considering the fast expansion and broad applicability of these devices. In 1989, FDA had prepared a general policy.
In 1989, FDA had prepared a general policy. It was withdrawn subsequently due to the growing complexities attached to computer software products as medical devices, and also the impracticalities of making an overarching software policy containing regulatory issues connected to all medical devices. By releasing the draft guidelines, FDA has acknowledged the need to act as regulator in matters of selecting software applications intended for use in mobile applications by manufacturers and distributors of these applications.
Why Regulatory Controls
Mobile applications are software programs that run on smart-phones and other mobile communication devices executed on a server. Development of mobile medical applications has opened flood gates of innovative technology looking for ways to improve health and healthcare. Innovation in software applications have paved the way for sprouting of several computationally powerful and user friendly mobile platforms, viz., smart phones, tablet computers, personal digital assistants, etc. Spurred by the sudden acceptability of these products, more and more complex mobile applications have started entering the market; some targeting individuals in their own health management and some targeting healthcare providers as tools that can improve delivery of patient care.
This called for the need to issue regulatory controls for these products by FDA by defining and classifying software devices and applications. It is more or less a balancing act between patient safety and innovation without any legal binding on manufacturers or service providers of these applications. Moreover, feedback from manufacturers, Healthcare service providers and IT professionals are sought by FDA on these new guidelines.
Why the Resistance
Many experts in the mobile technology field have come up with valuable suggestions. Prominent among them are The Health Information and Management Systems Society (HIMSS) and m-Health Regulatory Coalition. The coalition apprehends that approach of FDA towards regulating mobile medical applications are "too broad and would result in unnecessary regulation of m-Health technologies." Chairman of HIMSS Board of Directors along with the Organization's CEO has already written to the FDA stating that many hospitals and healthcare providers who are developing in-house mobile medical applications are unaware of FDA's regulations classifying them as mobile medical device manufacturers and also they do not have any knowledge about the draft guidance or any regulatory program. The coalition is of the view that vague definitions of devices and lack of clarity to issues like application and functions of EHRs and CDS may lead to resistance to the draft guidelines by other organizations.
Forward Path
In public interest FDA has to oversee safety and effectiveness of Mobile Medical Applications to parry any threat to patient safety and public health rising from proliferation in mobile medical technology. Therefore, educating the healthcare providers and developers about correct policies and practices and ensuring compliance lies with FDA. The move to invite feedback on the draft guidelines can further improve the regulatory role of FDA ensuring patient safety and encouraging innovations in m-Health.
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