Software development regulatory compliances are like watch-dogs or a police, which are introduced to ensure that the best practices and rules are adhered to while developing software. Irrespective of whether the software is desktop-based software, web-based software, a website, a mobile app, or an app for wearables, all need to follow the rules and standards laid down. If you are venturing into software development either as a tech company or as a consultant who wants to provide software development services, you need to abide by these standards and develop the software accordingly. The software you might be developing will store and process data that might be extremely personal, so right from its way of input, storage, processing, and removal, maintaining security is an essential aspect.

Governments across the world know the repercussions of data leaks and breaches of privacy and therefore, every country has ensured to have its own set of such compliances and standards which it expects the software companies and developers to abide by should they want to do business in the country. Being into software development and a top mobile app development company, we know that many aspiring entrepreneurs and startup founders are not aware of these regulations which they must consider from day 1 of their software/product development.

We have tried to cover the most common software development regulatory compliances that everyone should keep in mind while developing software products.

GDPR

Stands for General Data Protection Regulation and is by far the most talked about regulatory compliance in the software industry till date. It created a huge rush in the industry when it was introduced in 2018, replacing the old data protection directive of 1995. Technology companies were forced to make changes to their existing software products which demanded personal data from the users. GDPR is a regulation which is a set of guidelines for collection and protection of personal information. Some of the guidelines include:

  • Lawfulness, fairness, and transparency: Data processing must be lawful, fair, and transparent.

  • Purpose limitation: Data should be collected for specified, explicit, and legitimate purposes and not processed further in a manner incompatible with those purposes.

  • Storage limitation: Data should not be kept for longer than necessary for the purposes for which it is processed.

  • Right to be informed: Data subjects have the right to be informed about the processing of their personal data.

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Countries:** EU member states

Industry: GDPR is industry agnostic.

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HIPAA

Stands for H**ealth Insurance Portability and Accountability Act, introduced in 1996, is a U.S. federal law that sets standards for the privacy and security of personal health information (PHI). HIPAA is primarily concerned with protecting the privacy of individuals' medical records. Medical records hold a significant value, and their breach can have serious repercussions, not only for the individual but for the family as well. Any healthcare app development company must ensure that the apps are HIPAA-compliant for them to collect, store, and process the PIH data. Some of the rules included in HIPAA are:

  • Privacy Rule: This rule establishes standards for the privacy of PHI. It gives individuals certain rights regarding their PHI, such as the right to access, amend, and request the disclosure of their PHI.

  • Breach Notification Rule: The entities are liable to notify the affected individuals and the Department of Health and Human Services (HHS) in the event of a data breach that involves ePHI.

  • Security awareness training: Provide security awareness training for employees and use AI for teachers to create informative slides and educate them about HIPAA compliance.

  • HIPAA compliance officer: Designate a HIPAA compliance officer to oversee compliance efforts.

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Countries:** Primarily the United States

Industry: Healthcare

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PCI DSS

Stands for P**ayment Card Industry Data Security Standard and was introduced in 2004. It is a security standard introduced to ensure that all companies that accept, process, store, or transmit card information maintain a secure environment. It is mandated by the major credit card companies, including Visa, Mastercard, American Express, Discover, and JCB. Cardholder name, account number, CVV/CVC, PIN, expiration date are some of the parameters which are protected under this regulation. A few rules in this standard include:

  • Do not store cardholder data longer than necessary: Cardholder data should only be stored for as long as it is needed to process transactions.

  • Restrict access to cardholder data: Access to cardholder data should be restricted to authorized personnel.

  • Protect cardholder data with encryption: Cardholder data should be encrypted both at rest and in transit.

  • Install and maintain a firewall: A firewall should be configured to protect cardholder data from unauthorized access.

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Countries:** Globally mandated

Industry: eCommerce, FinTech, and any business that handles card payments.

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COPPA

Stands for C**hildren’s Online Privacy Protection Act, which was introduced in 1998. It was introduced to protect children’s privacy by setting up rules and guidelines for the websites and mobile apps which collect the data of children who are under the age of 13. A part of the Act also requires parental consent before collecting the personal information of children. It was introduced to safeguard the strata of society which are extremely vulnerable, i.e. children below 13. Some of the rules on COPPA include:

  • Limit the collection of personal information: Websites and online services should only collect personal information that is necessary for the purposes of the service.

  • Provide clear and comprehensive privacy notices: Privacy notices should not be subtle. It should explicitly explain how personal information is collected, used, and disclosed.

  • Allow parents to review and delete their child's information: Parents must be able to review their child's personal information and delete it.

  • Parental control options: Websites and mobile apps should be equipped with proper parental control options. Ex: How the parents can create a separate child profile on Netflix to ensure the content children receive is not explicit.

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Countries:** United States

Industry: Any industry or software targeting children.

** Does your website or mobile app comply with the regulatory standards? Contact today to check... **Contact us

SCORM

Stands for S**harable Content Object Reference Model, which was introduced in 2001, is more of a set of rules and best practices rather than a regulation which ideally can be followed by the businesses and software products that deal in e-learning. It is a set of specifications for e-learning content that allows content to be reused, tracked, and managed across different learning management systems (LMS). The EdTech development company that creates e-learning content can follow SCORM to ensure that their content is compatible with a wide range of LMS platforms. Four important properties include:

  • Reusable: SCORM content can be reused across different LMS platforms and courses.

  • Trackable: SCORM allows LMS platforms to track learner progress and provide feedback.

  • Manageable: SCORM content can be easily managed and updated.

  • Interoperable: SCORM content is designed to be compatible with different LMS platforms.

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Countries:** Globally

Industry: Typically EdTech and businesses in e-learning industry.

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PIPEDA

Stands for P**ersonal Information Protection and Electronic Documents Act and was introduced in Canada in 2000 and can be considered as a counterpart to the European GDPR. PIPEDA is a federal law which aims for the safe collection, use, disclosure, and storage of personal information. PIPEDA applies to all the organizations, software, and mobile apps who wish to handle the data of Canadians, regardless of their location. This means PIPEDA applies to all the organizations located in Canada as well as those who are located outside but conduct business in Canada. Some important rules of PIPEDA include:

  • Consent: Organizations must obtain consent from individuals before collecting, using, or disclosing their personal information.

  • Challenge of the Handling of Information: Individuals have the right to challenge the handling of their personal information.

  • Openness: Organizations must make their privacy policies available to individuals.

  • Data Breach Notification: Organizations must report data breaches to the Privacy Commissioner of Canada.

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Countries:** Canada

Industry: Every industry handling data of Canadians.

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EU MDR

Stands for M**edical Device Regulation which was introduced in 2017 in Europe. It is a comprehensive regulatory framework that governs the production and distribution of medical devices in the European Union (EU). It is aimed at ensuring the safety, performance, and quality of medical devices, including diagnostic tools and software used in healthcare. It requires manufacturers to meet stricter clinical data requirements, post-market surveillance, and labeling, among other things. A healthcare app development company should also complain about MDR in case they are developing software that interacts with a medical device.

  • Risk management: Software development companies must conduct a risk management process to identify and assess potential risks associated with their medical device software.

  • Notified body involvement: Software development companies must involve a notified body in the assessment of their medical device software.

  • Unique device identification (UDI): Software development companies must apply UDI to their medical device software.

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Countries:** EU member states and manufacturers who wish to sell devices in Europe.

Industry: Healthcare

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ISO/ICE 27001

This is an international standard introduced in 2005 for managing information security. It provides a framework or set of rules the organization should follow in order to establish, implement, maintain, and continuously improve an Information Security Management System (ISMS). By implementing risk management strategies, its aim is to protect the organization’s sensitive information, be it financial data, personal data, intellectual property. It is essential for software development companies to obtain an ISO 27001 certificate and follow the standard as it establishes a systematic approach to managing sensitive information, ensuring data security, integrity, and confidentiality. Adhering to this standard builds trust among clients.

Countries:** Globally

Industry: Industry agnostic. Applicable to all who handle sensitive data. Core industry include FinTech, EdTech, ECommerce, Healthcare, etc.

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PDPL

Stands for Saudi Arabia P**ersonal Data Protection Law. Introduced in 2023, this law can be considered as a Saudi Arabia’s GDPR, where the software agencies and organizations who intend to collect, store, manage, and use the personal data of the people of Saudi Arabia, need to comply with PDPL to ensure a fair usage of the personal data. Similar to GDPR, it has some similarities in its rules:

  • Obtain consent: It is mandatory for the companies to obtain the consent of the users before collecting, storing, using, and sharing the personal data.

  • Data minimization: Companies can only collect the data required for the purpose intended. Non-relevant data cannot be collected.

  • Security: Companies are liable to maintain the highest level of security for personal data to avoid data theft, unauthorized disclosure, and loss of data.

  • Cross-border transfers: Companies must comply with specific requirements for transferring personal data to other countries.

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Countries:** Saudi Arabia

Industry: Industry agnostic. Applies to all organizations who want collect, store, manage, and use the personal data of Saudi Arabia residents.

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APA

Stands for A**ustralian Privacy Act. Introduced in 1988, it is an Act aimed for fair and transparency in data collection, storage, usage, and sharing of the personal data of Australians. The Act as Australia’s GDPR to protect the unauthorized use of personal data. Any company, irrespective of the industry they are in, needs to abide by this law and inform the residents about what data will be collected, where the data will be used, why it is collected, and other aspects. Software development and technology startups, irrespective of their location across the globe, need to comply with the Act should they wish to handle Australian resident data.

  • Direct marketing: The APA imposes restrictions on the use of personal information for direct marketing purposes. Software companies must provide individuals with an opportunity to opt-out of direct marketing communications.

  • Cross-border data transfers: If a software company transfers personal information to a country outside of Australia, it must ensure that the recipient country has adequate data protection laws in place.

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Countries:** Australia

Industry: Industry agnostic. Applies to any company which intends to manage personal data of Australians.

Conclusion

Adhering to software development regulatory compliances is crucial for ensuring the safety, security, and privacy of user data. Whether developing a web-based application, a mobile app, or healthcare app development, these standards act as a foundation for building trustworthy and compliant software products. As the regulatory landscape continues to evolve globally, businesses and developers must stay updated with these guidelines to avoid potential legal issues and maintain user trust. At Nimblechapps, a top mobile app development company, we understand the importance of these regulations and strive to deliver secure and compliant healthcare app development solutions that meet industry-specific standards.