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Progression Report - May 2022

Applicaal team arranged an online board meeting on May. 19, 2022.

The subject was:

What regulatory does our Start-up need?

Minutes of meeting:

Finding the regulatory requirements for the APPLICAAL:

Research:

The Applicaal application and the business we intend to run on it are classified as health application device software. Initially, the team began researching and analyzing similar sources inside Canada, including Manitoba statutes.
Ms. Rashti agreed to take on this job and discovered various resources, which are mentioned below.
 1- manitoba.ca/ Families/ EIA Administrative Manual(1)
 2- Policy for Device Software Functions and Mobile Medical Applications.2
 3- Manitoba Healthcare System Information Management and Analytics (IM&A) Study

The summary of findings:
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. 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”) or on general-purpose computing platforms. Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms, the FDA is issuing this guidance document to clarify the subset of software functions to which the FDA intends to apply its authority.

Searching through all type of the mobile application definition in FDA document, it is found that Applicaal is categorized under the following definition:

B. Software functions for which FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act)

FDA intends to exercise enforcement discretion for software functions that:

  • Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; or
  • Automate simple tasks for health care providers.
  • Software functions that are specifically marketed to help patients communicate with healthcare providers by supplementing or augmenting the data or information by capturing an image for patients to convey to their healthcare providers about potential medical conditions – These products either pose little or no risk or are the sole responsibility of the health care providers who have experience with them in medical applications. Examples include.
  • Apps specifically intended for medical uses that utilize the mobile device’s built-in camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient’s skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between health care providers or between health care providers and patients/caregivers.
  • Software functions that are specifically marketed to help patients document, show, or communicate to providers regarding potential medical conditions – These products either pose little or no risk, or are the sole responsibility of the health care providers who have used them in medical applications. Examples include:
  • Software that serves as a videoconferencing portal specifically intended for medical use and to enhance communications between patients, health care providers, and caregivers.
  • Software functions that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is hosted on a web-based or other platform.
  • Software functions that are intended for transferring, storing, converting formats or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results and findings

Professional Advice:

The team discussed their findings with some industry experts and discovered that determining the exact regulation a business requires, as well as the prerequisites that must be met before applying for licenses, is a legal term that requires serious advice from professionals such as business lawyers.
As a result, the group decided to seek out a specialist and schedule a meeting with them to provide the Applicaal business with the necessary guidance.
In addition, the Applicaal team must produce documentation to safeguard consumers’ personal information and Applicaal from any extra-legal issues:

– Terms and Conditions
– Privacy and Policy

Cited:

1- https://www.gov.mb.ca/fs/eia_manual/sec6/6_9.html
2- www.fda.gov

The meeting took place on 2022-02-11


Attendances:
1- Dr. Peyman Etemadfar
2- Dr. Ali Chehrei
3- Mr. Mehdi Moeinimehr
4- Ms. Fatemeh Rashti
5- Ms. Banafsheh Reza (advisor)