The Journal of mHealth Vol 2 Issue 1 (February 2015) | Page 28

FDA Issues Draft Guidance on General Wellness Devices and Apps
»» A claim that a computer game will
diagnose or treat autism;
»» A claim that a product will treat muscle atrophy or erectile dysfunction;
»» A claim to restore a structure or
function impaired due to a disease,
e.g., a claim that a prosthetic device
enables amputees to play basketball.

may play an important role in health
outcomes should be generally accepted;
such associations are typically described
in peer-reviewed scientific publications.
Examples of chronic diseases for which
a healthy lifestyle is associated with risk
reduction or help in living well with that
disease include heart disease, high blood
pressure, and type 2 diabetes.

The second category of general wellness
intended uses is comprised of two subcategories:

The guidance gives examples of this category of disease-related general wellness
claims:

1) Intended uses to promote, track, and/
or encourage choice(s), which, as part of
a healthy lifestyle, may help to reduce the
risk of certain chronic diseases or conditions; and
2) Intended uses to promote, track, and/
or encourage choice(s) which, as part of a
healthy lifestyle, may help living well with
certain chronic diseases or conditions.

»» Product X promotes physical activity,
which, as part of a healthy lifestyle,
may help reduce the risk of high
blood pressure.
»» Software Product Y tracks your
caloric intake and helps you manage a healthy eating plan to maintain
a healthy weight and balanced diet.
Healthy weight and balanced diet
may help living well with high blood
pressure and type 2 diabetes.
»» Product Z tracks activity sleep patterns and promotes healthy sleep
habits, which, as part of a healthy
lifestyle, may help reduce the risk for
developing type 2 diabetes.

Continued from page 25

Both subcategories of disease-related
general wellness claims should only contain references where it is well understood that healthy lifestyle choices may
reduce the risk or impact of a chronic
disease or medical condition. That is, the
claim that the healthy lifestyle choice(s)

The FDA has clarified that the General Wellness policy will not extend to
devices that present inherent risks to a
user’s safety.
Whether a device is low-risk for purposes of the guidance is determined by
whether or not the product:
1. is invasive;
2. involves an intervention or technology that may pose a risk to a user’s
safety if device controls are not
applied, such as risks from lasers,
radiation exposure, or implants;
3. raises novel questions of usability; or
4. raises questions of biocompatibility.
Where the answer to any of these questions is yes, then the device would not
be considered a low-risk general wellness
product and therefore not covered by
the guidance.
The FDA is seeking input on the draft
guidance documents from industry and
other stakeholders during the comment
period. For more information please or
to read the draft guidance visit www.fda.
gov/MedicalDevices/ResourcesforYou/Industry/ucm430911.htm n

Digital Mobile Solution Places
International Travellers in Control
of their Healthcare Worldwide
The health insurance industry is becoming increasingly interested in how it can
help customers achieve better quality
of life, reduce premiums for those that
actively manage their health, develop
better and more efficient relationships
with health professionals and differentiate products in the marketplace. Digitisation has a large role to play in this
and, as part of this commitment, private
medical insurance customers with British multinational insurance company
Aviva can now use a specially developed
smartphone app that provides access to
securely stored personal medical records
and immediate access to emergency
assistance and medical advice, wherever
they are in the world.

26

February 2015

Produced in partnership with Oxfordshire-based Medelinked, the Aviva International Solutions App - which is available
for both Apple iOS and Android smartphones - enables the Company’s customers to record a range of medical details
including allergies, conditions, immunisations, medications and tests, and has the
ability to store images of scans, x-rays and
certificates to complete their health profile. This provides users with the peace
of mind that, if they need urgent medical
treatment abroad, their medical history
can be quickly and safely accessed and
shared from their mobile device.
The customer has sole control over the
information that is stored and can decide
whether they wish any healthcare profes-

sional or organisation to view any part
of their medical history. Aviva is unable
to access any of the data, unless the user
chooses to share any records with them.
The customer can also choose any information they would like to store in a
password-protected E mergency Records
area, which a chosen family member or
colleague can immediately access in the
event of an emergency.
When healthcare or emergency support
is needed, the app enables customers
to dial straight through to Aviva and its
24-hour emergency assistance and medical advice service, as well as to a list of
their healthcare providers. There is also a
clear step-by-step guide on how to make