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:
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
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)