The legal aspects of launching a pharma app

Adina Humayoon
Adina Humayoon

February 24, 2022

The legal aspects of launching a pharma app

Medical applications and devices usually have a separate fanbase amongst the audience. Not only do they cater to many users’ pet peeves of reducing hospital and pharmacy visits, but also provide near to accurate results. Health and pharmacy apps have been a source of great help throughout the pandemic by reducing the hefty visits to a pharmacy and standing in long queues to get even the basic medicines of sorts. 

As stated, as much as it makes a citizen’s life simple, it’s extremely tricky to create a pharmacy app and get it right in the first go. A lot of aspects find themselves involved if words like healthcare, pharmacy, or medicine are a part of it.

If any mobile app is fulfilling a medical purpose, then according to FDA (US Food and Drug Administration), it is subject to get approval from FDA in order to launch in the market. 

“If a mobile app is intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease) it is a medical device and therefore subject to FDA oversight.”

This is true by all means because most of the applications found on the Apple App Store and the Google Play Store do enable users to use their mobile phones as medical devices with the assistance of these applications. So naturally, FDA has to intervene to maintain their guidelines and regulations. 

With that said, FDA is not the only legal aspect that a pharma app development company has to follow. The company does not have much of a choice, as the health regulator’s approval is necessary for it to pass through to the right audience.

If you are new to the healthcare industry or are looking forward to creating an impactful product in the healthcare sector, like a pharmacy application, then these are some of the legal factors you must abide by before pushing the final product out in the market.

legal aspect of pharmacy app

HIPAA

HIPAA also known as the Health Insurance Portability and Accountability Act of 1996 is a federal law that revolves around protecting the patient’s sensitive information from being disclosed. This information consists of the ones users have entered on your application while creating an account or placing an order for their medical and pharmaceutical needs. 

HIPAA’s involvement in a healthcare and pharma application is something that will be inevitable now, or in the future after you have developed your application. It is wise not to rely on any app developers to keep your application in compliance with the HIPAA regulations and to understand the data aspects of the application themselves. 

It’s smart and safe to plan ahead when creating pharmacy apps or other healthcare apps which require you to insert information that is linked to your medicinal history. Complying with the HIPAA regulations from the initial stages of pharma app development will keep you on track regarding the security rules and disclosures to prevent you to breach any HIPAA laws due to your application. 

Sales tax

Healthcare applications that revolve around the concept of buying and selling, like online pharmacy apps, must comply with the sales tax allocated for each product by the government. You as an owner must be familiar with the tax situation of your state and the ones from where you are generating your supplies.

Not all states follow the same tax laws, so a thorough investigation of each product is necessary. Some taxes may be high, some low, so in order to stay up to date on your tax returns and avoid trouble with the authorities over your it, complete your research on all ends and conduct your online business accordingly.

Privacy laws (National and International)

Most pharma apps have their bases defined when it comes to the location and the geographical reach of their company. But this comes after close consideration of all the aspects that are involved in the vast reach of the application and its audience. It is common for pharmacy apps to see the light of the day in states other than their own, so software development applications have to keep a keen eye on all the legal technicalities involved.

The state/countries privacy laws, tax and financial regulatory, all these factors must be in consideration. If the app is operating and conducting sales in other states, it must abide by their privacy laws regarding the seller and the buyer, the patient themselves.

Be aware of the healthcare regulatory environment

Healthcare authorizations and regulations go far beyond FDA or HIPPA. Apart from the regional and international laws, pharma app development companies must prepare themselves for other regulators with whom they may have never interacted before.

Healthcare applications and online medical apps tend to make developers vulnerable for further investigation and check and balance. If your health care app takes a leap on the internet, then you may subject yourself to the rules of various third-party companies, even those of the Federal Trade Commission’s Rules and Regulations, so always be prepared for the unseen. 

FAQs for Legal aspects of launching a pharma app

Medical apps that attempt to perform functions of a medical device are the ones that FDA regulates. Other than that, applications that are used to monitor medical records, patient care, educational and medical training, and so on are not bound by FDA regulators.

Pharmaceutical regulations are for the safety and well-being of the patient and the medical staff itself. These regulations perform a check and balance on the drugs that are launched in the market along with their quality control and usage.

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