HIPAA Compliance for Healthcare Software Development

Due to the enormous revolution of technology in the recent and upcoming centuries, every development sector requires improvements in the equipment they use. The whole world requires software and hardware engineers who can develop and develop the necessary materials and software to run their work. Some sectors that need technological advancements include the education sector, healthcare sector, transport and communication system, and other state sectors of great importance. Since the inception of supercomputers, the number of people who learn computer language and programming is increasing year after another.

The healthcare sector needs some software that will help keep records of particular medicine and health records of patients in the form of electrical software. The government uses various apps to provide information about specific illnesses and their possible medication. Software developers are essential in the integration of healthcare apps. The overall software market of healthcare software worldwide grows at 13% and may reach 76.45 by 2025. The rate might increase by 43.9% in 2027. The growth shall gradually grow because of the eruption of covid-19 in the entire world. The development of healthcare apps will majorly be witnessed in specific areas, including wearable technology, the internet of medical things, telemedicine, artificial intelligence, and augmented and virtual reality. All places that shall witness the changes in technology will have several advantages to human health and will help in medical discoveries, reduce the cost of health care, and improve patients’ health.

HIPAA exists to help you to create a healthcare app. Your app needs to interact with electronically protected health information. HIPAA means Healthcare Insurance Portability & Accountability Act. The law requires business associates and the covered entities to self-regulate and comply with the set standards concerning their security systems. The USA has various data protection laws that govern and regulates whatever an individual or entities practice. HIPAA is one of the data protection laws. We shall learn about the process of developing software that complies with HIPAA rules and regulations.

The healthcare software that need to comply with HIPAA rules

Any person that develops a mobile healthcare app or healthcare software should follow HIPAA rules. Below are some of the questions to answer before developing the healthcare app or software:

The type of entity that shall use the application

The onus for compliance will fail with the business associates or covered entity according to HIPAA. Some of the covered entities include health plans, healthcare providers, or healthcare clearinghouses.

The type of data that the application will use, store or share

HIPAA rules regulate healthcare apps that plan to record, communicate or store PHI when in use. Electronically protected health information and Protected health information contains data concerning the patient, including email address, name, location, payment information, imaging or lab results, date of birth, device identifiers, SSN, addresses, and medical history.

Examples of mHealth and healthcare apps that need to comply with HIPAA rules include private messaging, secure or telemedicine apps, HER apps, healthcare apps that help to communicate and collect data from relaying to the healthcare workers, lab results or medical records apps and patients medication compliance or patient monitoring apps.

Healthcare software developers should be aware of HIPAA requirements regarding specific workflows, including PHI removal or security control. With the number of wearable tracking devices or mobile marketplace, the mHealth apps are booming. Not all apps need to comply with HIPAA rules. HIPAA is limited to regulating third-party health apps used by physicians though chosen and used by patients. HIPAA can cover the third party when the app developer is a business associate of a covered entity. Some of the apps not covered by HIPAA include exercise or fitness apps, mental health tracking or personal health apps, and diet or nutrition tracking apps.

Requirements of HIPAA compliance 

Apps need to meet the requirements given by HIPAA and the rules related to legislation and amendments. HIPAA has many rules and penalties and some liberty on how app developers can apply some restrictions, therefore, making HIPAA both vague and strict.

hipaa compliant software requirements

Rules and regulations required by healthcare software applications 

  • The HIPAA privacy rules

The HIPAA Privacy Rule was first enacted in 2002 to protect the confidentiality of patient medical information. HIPAA privacy rules apply to healthcare institutions and plans, medical cleaners, and business partners who have access to protected health information. Protected health information consists of 18 “personally identifiable health information” that may disclose the patient’s identity, medical history, or payment history individually or collectively. HIPAA privacy rules do not apply only to written data. The HIPAA Privacy Rules also protect videos and images that contain personally identifiable health information. PHI may only disclose to a third party with the patient’s consent unless the disclosure is related to health care treatment, healthcare payments, or healthcare operations. Even if these conditions are met, the target entity and business partner must comply with the “minimum mandatory rules” regardless of the circumstances. There are different types of threats to PHI integrity.

  • HIPAA security rules

Which specific HIPAA security requirements determine the security rules? Security rules require entities to analyze their security needs and take appropriate and appropriate security measures following HIPAA security requirements. Safety rules do not specify which particular HIPAA safety requirements or standards should be used by a specific organization of a specific size. Financial institutions have room to decide which security measures work best.

Security rules require that entities consider when implementing security measures: Size, complexity, and functionality.

  • Hardware and software technical infrastructure

Safety measures costs; the Potential and potential risks of the API needs to be considered. Security rules also require that the entity in question is not “quiesced.” Target entities should continually review and modify security measures to ensure ePHI is always protected. What are the three criteria of the HIPAA Safety Regulations? The HIPAA Safety Regulations include what is known as three mandatory implementation standards. The target entity and BA must comply with each of these. Security rules require three types of security measures: management, physical, and technology.

  • The breach notification rule

Following an unprotected PHI breach, the subject entity must notify stakeholders, the Secretary of Health and, and in some cases, the media, of the breach. Business partners must inform the affected entity if a crime is committed at or through the business partner. This technology issues notifications following Health Information Technology (HITECH) Law for Health Economics and Clinical Law and other applicable federal or state notice laws. Caution is required if the PHI is secure by encryption, but the secretary must keep the encryption key on a separate device than the data to be encrypted or decrypted. The content of this policy is not intended to require the components of interest to provide information to lawyers/clients, qualified mental health professionals, or other privileged individuals. In addition, the NIU Hybrid Eligible entity does not disclose the names of employees or other persons involved in breaches or certain sanctions against such employees.


Developers need to learn the process of developing software of healthcare that complies with above rules. The HIPAA provides the tools that people require to make laws concerning healthcare software. HIPAA shall also regulate the creation of new apps. The developers of apps need to conduct a risk assessment before developing a healthcare app. The data in the healthcare app needs to be secured and minimized.

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Written by:

Muzammil K

Muzammil K is the Marketing Manager at Aalpha Information Systems, where he leads marketing efforts to drive business growth. With a passion for marketing strategy and a commitment to results, he's dedicated to helping the company succeed in the ever-changing digital landscape.

Muzammil K is the Marketing Manager at Aalpha Information Systems, where he leads marketing efforts to drive business growth. With a passion for marketing strategy and a commitment to results, he's dedicated to helping the company succeed in the ever-changing digital landscape.