Tag Archives: software

Riding the wave of Software as a Medical Device

For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads, other territories will follow.

It’s probably little surprise, given that software apps rely upon a stable platform to operate effectively.

If, like us, you’ve ever experienced an update to one of the apps on your smartphone either “break” functionality or impact on how another, seemingly unconnected, app performs, then you will appreciate why this is a challenge that needs to be resolved.

FDA publishes and updates guidance documents

Signs of the changes for Software as Medical Devices (SaMD) are mainly found in the activities of the FDA (the US regulator for drugs and medical devices) and forms part of the US government’s drive to bring regulation up to date, by passing the “21st Century Cures Act” into law.

Agency guidances have since been published for a range of topics;

Clearly, FDA view the changes as important to the health of the US populace.  Taking the case of apps used to support drug treatment as just one example, here’s what the FDA commissioner, Scott Gottlieb had to say;

“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge”

International guidance for software as medical devices

The flurry of activity comes on the heels of the last in a series of documents produced in the area by the IMDRF (International Medical Device Regulators Forum).

Perhaps you’re not too familiar with the work of the IMDRF? That’s ok, it is after all a rather niche topic. Regulators from the EU and 9 countries have been working together “to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device”.

Work completed by this IMDRF working group produced a suite of guidance documents relating to SaMD, including;

If you’re considering, or are already a long way down the path to, developing, pure software medical devices or “accessory” apps, such as those used to manage a chronic disease such as diabetes, then you need to be aware of the shift and adjust your approach accordingly.

Help is at hand for software as a medical device

Clearly, there’s a lot to take in with the swathe of documents, before assessing the impact the changes may have upon your development plans.

Over the coming weeks, we’ll be sharing insights for each of the documents mentioned in this article.

Subscribe (add your email to the box on the right of this page), to ensure that you’re alerted as soon as new information is published.

Perhaps you want to get to grips with the changes today?  Get in touch now.

9 questions to find out if your app is a medical device

It seems like every month another raft of “wellness” apps and “not-medical” apps are released into the wild. There’s clearly a lot of energy being expended to create apps that help people manage their lives, wellness and medical conditions. However, many developers that we speak with are really not sure how to tell if their wizzy new project needs to be worrying about complying with medical device regulations.

Navigating medical app development

FTC mobile app tool

Click to visit the tool

Help is at hand, if you’re developing an app that collects, manages or creates user data, diagnoses or treats diseases, for the US market. The US Federal Trade Commission (FTC) has launched an online tool to help you understand which (if any) of these laws and regulations you will need to comply with:

  • Health Insurance Portability and Accountability Act (HIPAA), enforced by the US Department of Health & Human Services
    Click here to show more
    The Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information and require certain entities to provide notifications of health information breaches.
  • Food, Drug & Cosmetic Act, enforced by the FDA
    Click here to show more
    The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps. The FDA focuses its regulatory oversight on a small subset of health apps that pose a higher risk if they don’t work as intended.
  • Federal Trade Commission Act, enforced by the FTC
    Click here to show more
    The FTC enforces the FTC Act, which prohibits deceptive or unfair acts or practices in or affecting commerce, including those relating to privacy and data security, and those involving false or misleading claims about apps’ safety or performance.
  • Health Breach Notification Rule, enforced by the FTC
    Click here to show more
    The FTC’s Health Breach Notification Rule requires certain businesses to provide notifications following breaches of personal health record information.

Finding out if your app is a Medical app

The tool holds your hand through answering 9 questions, resulting in guidance about which (if any) of these laws apply to your product.

1. Do you create, receive, maintain, or transmit identifiable health information?

2. Are you a health care provider or health plan?

3. Do consumers need a prescription to access your app?

4. Are you developing this app on behalf of a HIPAA covered entity (such as a hospital, doctor’s office, health insurer, or health plan’s wellness program)?

5. Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?

6. Does your app pose “minimal risk” to a user?

Click here to show more about 'minimal risk'

According to the FDA, “minimal risk” apps are those that are only intended for one or more of the following:

  • helping users self-manage their disease or condition without providing specific treatment suggestions;
  • providing users with simple tools to organize and track their health information;
  • providing easy access to information related to health conditions or treatments;
  • helping users document, show or communicate potential medical conditions to health care providers;
  • automating simple tasks for health care providers;
  • enabling users or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems; and
  • transferring, storing, converting format or displaying medical device data, as defined by the FDA’s Medical Device Data Systems regulations.

7. Is your app a “mobile medical app?”

Click here to show more about medical apps
A “mobile medical app” is one that is intended for any of the following:

  • use as an accessory to a regulated medical device (for example, an app that alters the function or settings of an infusion pump)
  • transforming a mobile platform into a regulated medical device (for example, an app that uses an attachment to the mobile platform to measure blood glucose levels)
  • performing sophisticated analysis or interpreting data from another medical device (for example, an app that uses consumer-specific parameters and creates a dosage plan for radiation therapy)

8. Are you a non-profit organization?

9. Do you offer health records directly to consumers (or do you interact with or offer services to someone who does)?

Developers unfamiliar with the requirements surrounding medical devices, such as the Quality System Regulation, FDA registration and approval process may find the tool useful in understanding whether the “thing” they’re creating qualifies as a medical device.


Evaluate your medical app development project

Talk with us about your medical app, because an independent view of your development project checks you’re on the right track.

Four becomes five

We’re delighted to welcome David Andrew to the Three Circles team.

David Andrew photo for blogDavid brings a wealth of practical experience of software development and validation in regulated industries, including nuclear, along with a wicked sense of humour!  His expertise is a strong complement to our skills, helping you develop medical devices incorporating software so they’re compliant from concept models through to regulatory submission.

Matthew and David have previously worked together on quality and validation projects for pharma and biotech clients, having lots of fun while getting the job done quickly and thoroughly.  So it’s great to have the opportunity to work together again.