The laws which an app owner needs to follow for his healthcare apps will be explained in the most simple manner and in a layman language.
If you are facing any difficulty in understanding what rules, laws, and regulations you need to follow for your healthcare apps then you have just come across the right article.
Depending on the potentiality of healthcare apps there are several rules and regulations that an app must follow and violations of such laws may have negative consequences for apps.
Several federal laws that are applied to all the healthcare apps are:
USA healthcare laws and regulations:
The USA is the leading country when it comes to the healthcare industry and getting in the market is quite difficult.
As strict healthcare laws and approvals act as a barrier to launch any products of health and medicines in the USA market.
Healthcare laws are more strict when compared to other countries of the world as there are three major bodies of the federal government which further decides and gives authority to the apps:
- Food and drug administration
- Federal trade commission
- Office of civil rights
These bodies majorly decide what can flourish in the market and what can not get into the market of the United States.
Let us discuss several laws and regulations in detail:
1. Health Insurance Portability and Accountability Act (HIPAA)
The human and health service department in the United States administers the HIPAA rules which secure the health information and maintains its privacy.
HIPAA along with congress agreed that electronic transaction of data in healthcare will result in breaching the trust of patients and there might be other frauds with data.
To prevent such malpractices there are various laws and guidelines in HIPAA that are mandated to follow.
HIPAA also asks several entities to issue notifications of any violations with regards to the information of the patients.
2. Federal Food, Drug and Cosmetic Act (FD&C Act)
The food and drug administration wing implements the FD&C Act and such Act controls and facilitates a secured way to make the apps successful.
Depending upon the category of the healthcare app, the FDA may intervene when there arises a need to oversee the functioning of the app.
This includes the health apps that have higher risks when they can not perform well and according to the guidelines provided under such act.
3. Federal Trade Commission Act (FTC Act)
Unfair practices that prohibit law are taken into consideration by FTC which further also affects interstate commerce between the states.
False health claims and its representations when it comes to the performance of the apps are overlooked by this Act.
Other claims that whack consumer data – its security and privacy.
4. Health Breach Notification Rule (FTC)
These rules and regulations provide information to all the customers when there is an infringement of data privacy and harm to its security.
Whenever the apps don’t function according to the provided guidelines then the customers are notified about their status of data.
5. Lanham Act
This law is the prime law that controls the registration, patents, copyrights, and use of trademarks in the markets of the United States.
The trademarks and logo used by the company must be cleared and registered under such a department to avoid any issue further which may arise due to negligence in this department.
If the trademarks and patents are used from the third party then they must be put before such departments to get the things to settle and continue to use such patents and trademarks.
6. US Copyright Act
The copyright laws in the United States protect the original works of authorship which get fixed by the tangible medium.
The codes which are written for mobile healthcare apps are subjected to registration, protection, and enforcement under this Act.
7. US patent Act
Digital health apps and its technology may get patent but still, it totally depends on the category of the app.
When there is something innovative and above the earlier categorization then it gets its patent very easily.
The laws and regulations when gets levied on anything the main motive behind such things are to make things better for the long run.
Laws at an early stage while getting approval and authority might appear difficult and might act as a hindrance but once it is done it will make the things more smooth.
To comply and work according to the laws is the perfect way to avoid any harm to goodwill and litigations which might appear in the later stage when apps get the desired results.