2014 Digitas Health LifeBrands

REGULATORY ALERT: FDA Revises Mobile Medical Apps Guidance

Page 1

DALE COOKE, VICE PRESIDENT/GROUP DIRECTOR, REGULATORY
June 20, 2014
Regulatory Alert:
FDA Revises Mobile Medical Apps Guidance
On June 20, 2014, the Food and Drug Administration (FDA) released a new draft guidance entitled
Medical Device Data Systems, Medical Image Store Devices, and Medical Image Communications
Devices.
i
This guidance significantly reduces the regulatory status of MDDS, in essence, eliminating
all regulatory requirements for these medical devices. As dramatic as that position change is, this
guidance is more likely to be known for the changes it makes to the September 2013 finalized
guidance on mobile medical apps (MMA).
ii
In particular, this guidance moves the entire category of
MDDS devices from the set of apps will FDA will focus its enforcement activity into the category of
apps where FDA will exercise enforcement discretion.
iii

In light of this guidance, Digitas Health LifeBrands recommends companies take the following
actions
iv
:
1. Review existing app development to determine whether the expansion to enforcement
discretion applies.
2. Review enterprise-level app development guidelines, protocols, and best practices to
determine what updates are needed in light of the new categorization.
3. Consider new partnership opportunities with makers of wearable devices for the
integration of data.
4. Consider the integration of data from existing apps that have established application
programming interfaces (APIs) for exporting and importing data.
5. Prepare for the greatly expanded data integration that will be facilitated via Apples iOS8,
Google Fit, and Samsungs S Health platforms.
BACKGROUND
The final guidance on MMA set out three categories of mobile medical apps:
1. MMAs that are not medical devices.
2. MMAs that are medical devices where the FDA intends to focus its enforcement efforts.
3. MMAs that are medical devices, but where FDA intends to exercise enforcement
discretion.



2014 Digitas Health LifeBrands
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Enforcement Discretion
The phrase enforcement discretion is a technical term and can cause some confusion. When FDA
states that it intends to exercise enforcement discretion in an area, it is asserting:
1. FDA has the legal authority to enforce legal and regulatory requirements in that area.
2. FDA will not use that authority.
In the context of MMA, FDA was establishing a category of apps that it viewed as being low risk and,
consequently, not meriting the full exercise of regulatory requirements. With the MDDS Guidance,
FDA is taking three types of medical devices, and shifting them from the category of FDAs focus in
enforcement to the category of withholding enforcement.
MDDS
MDDS is defined in the guidance as:
MDDS is a medical device intended to provide one or more of the following uses, without
controlling or altering the functions or parameters of any connected medical devices:
The electronic transfer or exchange of medical device data. For example, this would
include software that collects output from a ventilator about a patient's CO2 level and
transmits the information to a central patient data repository.
The electronic storage and retrieval of medical device data. For example, software that
stores historical blood pressure information for later review by a healthcare provider.
The electronic conversion of medical device data from one format to another in
accordance with a preset specification. For example, software that converts digital data
generated by a pulse oximeter into a digital format that can be printed.
The electronic display of medical device data. For example, software that displays a
previously stored electrocardiogram for a particular patient.
v

Any apps that do not control devices, or alter the functions of devices will not now be subjected to the
regulatory requirements associated with being a regulated medical device. In addition, apps (and other
medical devices) that merely provide storage and retrieval of medical images and that provide
electronic transfer of medical image data between medical devices will also no longer be subjected
to FDA enforcement activity.
vi




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RECOMMENDATIONS
In light of this guidance, Digitas Health LifeBrands recommends companies take the following actions:
1. Review existing app development to determine whether the expansion to enforcement
discretion applies.
2. Review enterprise-level app development guidelines, protocols, and best practices to
determine what updates are needed in light of the new categorization.
3. Consider new partnership opportunities with makers of wearable devices for the
integration of data.
4. Consider the integration of data from existing apps that have established application
programming interfaces (APIs) for exporting and importing data.
5. Prepare for the greatly expanded data integration that will be facilitated via Apples iOS8,
Google Fit, and Samsungs S Health platforms.

i
Hereinafter, MDDS Guidance last accessed June 20, 2014, from
ii
Guidance for Industry: Mobile Medical Applications, last accessed from
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/UCM263366.pdf on September 24, 2013. Hereinafter, Final Mobile App Guidance. On
that guidance, see also http://www.scribd.com/doc/170875173/DH-Regulatory-Alert-Mobile-App-
Guidance-Finalized
iii
For more on enforcement discretion, see below and the DH Regulatory alert referred to in note
ii.
iv
In this Regulatory Alert, I make no distinction among medical devices, biologic products, human,
and non-human animal drugs. The essential regulatory requirements for all are the same, and
the descriptions and recommendations of this alert should be applied to all categories with only
minor modifications.
v
MDDS Guidance, page 5
vi
MDDS Guidance, page 6