Healthcare app laws to consider to develop a healthcare app in Ontario, Canada
2 years ago
The unprecedented situation caused by COVID-19 is altering the way people have been accessing essential services, especially healthcare.
Considering the fact that the healthcare industry will thrive in the post-COVID-19 era, entrepreneurs and several healthcare entities are investing a lot in digital healthcare solutions such as healthcare mobile apps.
However, developing a healthcare app that satisfies all legal norms federal and state governments have imposed under different acts is an uphill battle.
Giving cold shoulder to healthcare app legislation can leave you in the legal battle and make you liable to a many thousand dollars fine.
Sensing the gravity of the situation, we will list 5 key considerations that you should keep in mind to develop a healthcare app in Ontario, Canada while satisfying all laws.
We will also share how SyS Creations can help you to plan, design, develop, and deploy any kind of healthcare app in the market.
But before all of this, let’s first discuss the most recent victim of Canadian healthcare app legislation.
A most recent victim of Canadian healthcare app laws
The Alberta Privacy Commissioner is going to investigate one of the most popular virtual healthcare apps, Babylon by TELUS Health.
After concerns have emerged over privacy compliance, the Alberta Privacy Commissioner is launching two investigations.
The first investigation will address the compliance concern and another investigation will find out whether the app is satisfying the Personal Information Protection Act.
Information and Privacy Commissioner Jill Clayton discouraged the use of the app while the investigation is going on.
Another company named Clearview was the second victim.
After initial complaints and reports, the federal privacy commissioner, and privacy commissioners of Alberta, British Columbia and Quebec launched the inquiry against Clearview.
Needless to say that the investigation will influence the company’s reputation and revenue very dramatically.
Such a situation can definitely push a small company to a dead end. This is the reason why it is always better to spend some more time studying the healthcare app legislation.
SyS Creations is the top Ontario-based healthcare app development and IT consulting firm.
After serving 7 years in the Canadian healthcare industry, our team has earned expertise to develop healthcare apps while not disobeying healthcare app legislation.
The following are the 5 key considerations our legal advisers and business experts have listed out.
Legal things to keep in mind before going for healthcare app development in Canada
- PHIPA Compliance
A healthcare app saves many confidential patients’ personal information and medical data.
To avoid the abuse of this data and ensure data privacy and security, the government has imposed many rules under PHIPA which you as the app owner should know.
PHIPA, known as the Personal Health Information Protection Act, was established in 2004 to govern personal health information. PHIPA establishes the rules for data collection, data use, and disclosure of the personal health information of the patients.
Your healthcare app should be PHIPA compliant.
If an individual is found guilty of committing an offence under PHIPA, he can be liable for a fine of up to $100,000.
And if an organization commits an offence under PHIPA, it can be liable for a fine of up to $500,000.
You should read this: PHIPA Ontario Requirements
- A Medical Device Licence
If your healthcare app involves medical devices to collect information, a medical device licence needs to be granted by Health Canada before marketing for apps in higher-risk categories.
However, lower-risk apps that use medical devices to collect a few basic data such as weight do not require a licence.
What makes getting a medical device licence a challenging task is the fact that, unlike the UK and USA, a specific guideline about which types of mobile apps fall under each medical device category is lacking in Canada.
- Secure Electronic Signature
A healthcare app sends many important documents especially prescriptions to different healthcare entities over the Internet.
In such a scenario, there should be a module or mechanism which authenticates the document.
To address this challenge, you have to implement a unique prescription authorization process. It acts similarly to a password.
It generates a digital signature on each prescription as a prescriber generates it electronically.
- OHIP (Ontario Health Insurance Plan) and OHIP Billing Codes
Canada has one of the most refined healthcare systems.
The OHIP is the government-run health insurance plan for Ontario. Any Ontario resident is entitled to access healthcare services including emergency care and preventive care under OHIP free of charge.
In other words, the physicians who diagnose patients are paid by the government, not patients.
Meaning, you should integrate a module in your healthcare app to enable physicians to submit invoices of who they diagnosed.
For that, your app should support OHIP billing codes. Each healthcare service physicians provide corresponds to a fee billing code with a specific dollar amount.
This is worth reading: Cost to develop your own medical billing software
- Medication Incident Reporting
A medication incident is nothing but a mistake with medication.
Medication incidents generally include obvious things like receiving the wrong dose.
If such an event happens in your healthcare organization due to system error or transcription error, you should generate the medication incident report. It is compulsory.
Medication Incident Reporting (MIR) provides healthcare professionals with a means to document and submit the incident.
So, in order to enable your team members to submit a medication incident report quickly, the admin panel of your healthcare solution or app should be equipped with a MIR module and you should also train your team members to generate a medication incident report.
Get a compliant healthcare app developed with experts
Being the top healthcare app development and compliance consulting firm in Ontario, we understand how important it is to follow healthcare app legislation.
Thus, we help entrepreneurs and healthcare entities planning to develop healthcare apps in Ontario with legal help as well as app development.
We are skillful enough to define app workflow and turn any idea into reality.
Our legal advisers, business experts, app developers, and app designers make your business journey painless.
You can recieve expert development and legal help from us by contacting us.