Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff – FDA – 25 September 2013

Posted on September 25, 2013. Filed under: Health Informatics | Tags: , , , |

Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff – FDA – 25 September 2013

Extract from the introduction:

“The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.

Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories.

Consistent with the FDA’s existing oversight approach that considers functionality rather than platform, the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. This subset of mobile apps the FDA refers to as mobile medical apps.

FDA is issuing this guidance to provide clarity and predictability for manufacturers of mobile medical apps.”

… continues

Commentary on this:

FDA outlines rules for medical apps on phones, tablets – The Hill – 23 September 2013

FDA Updates Guidance on Mobile-Software Apps – The Wall Street Journal – 23 September 2013

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Legacy Application Modernisation in the Public Sector: An Executive Briefing designed to stimulate debate and feedback – Oracle

Posted on October 8, 2010. Filed under: Health Informatics | Tags: , |

Legacy Application Modernisation in the Public Sector: An Executive Briefing designed to stimulate debate and feedback – Oracle

Executive Overview

“This paper aims to stimulate debate, discussion and action among public sector IT and organisational leadership
teams, as they consider the future evolution of their IT systems. It is Oracle’s view that modernisation of both
legacy applications and IT infrastructures will be vital for central and local government and non-departmental
public bodies alike, if they wish to ensure their IT is fit for the future and gain the cost savings that are being
demanded through better IT and business efficiency.

Current IT systems have evolved over decades and become a complex mixture of legacy technology including
bespoke, commercial and in-house developed applications. Data resides in inefficiently managed silos, on a mix
of hardware platforms which include mainframes and thousands of servers. These systems are ageing, inflexible
and risky. They are often undocumented and highly dependent on legacy software skills and individual IT operators
who may be coming towards the end of their career in public service or be vulnerable to the forthcoming
redundancies. This paper starts by focusing on why modernisation is necessary and looks at drivers for change.
These are not only technical but come from increasingly urgent policy imperatives including cost reduction,
efficiency improvement, the need to harmonise information between agencies and across international borders.
These have intensified in the new administration which is also radically streamlining government agencies,
creating new needs to integrate disparate systems yet ensure that vital services do not falter.

The paper goes on to discuss the barriers to change, which are significantly influenced by fear and resistance.
Disruption of operations and services is often perceived as a risk, but IT modernisation can be smoothly conducted
without this and deliver benefits that go far beyond technology.” 

…continues

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