Building healthcare software typically means handling a lot of sensitive data, such as medical histories and patient information. If you choose to outsource your healthcare software development process, you must still ensure HIPAA compliance. The stringent regulations established by HIPAA are crucial for safeguarding your patients and maintaining the integrity of your organization.
How Does HIPAA Impact Healthcare Software Development?
The Healthcare Information Portability and Accountability Act (HIPAA) was enacted to help protect workers and their dependents who lost insurance coverage due to a change in employment. It also serves to safeguard the confidentiality of patients’ health information. The law requires any entity that prints, stores, reviews, or accesses personally identifiable health information to take certain steps to keep data secure.
However, it’s important to note that not every software project connected to health requires HIPAA compliance.
The regulations apply to the use, storage, collection, or dissemination of protected health information by an entity other than the individual. Thus, for example, if you are developing a mobile app that allows an athlete to record his pulse rate or workout duration for his personal analysis, HIPAA regulations do not apply. If, however, this same app has the ability to transmit the data to the team’s physician, it must be HIPAA compliant, even if the option to transmit is never used.
Assuming that you have determined that the project requires HIPAA compliance, you must bear the responsibility for ensuring it meets all regulations. HIPAA compliance requires safeguards that are classified as administrative, technical, or physical. When developing a project that must be HIPAA compliant, you should ensure that your company meets the minimum standards in all three categories.
Meeting the Requirements of HIPAA and HITECH
HIPAA was enacted in 1996, before smartphones, tablets, wearable devices, and cloud computing. Advances in technology have increased the difficulty of complying with the regulations. The passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) raised the stakes even further.
HITECH serves to encourage the use of electronic health records by penalizing healthcare providers who do not make “meaningful use” of digitized records. It rewards providers that do with the opportunity to receive incentive payments from the federal government.
Since HITECH does not supersede HIPAA, all healthcare software development must comply with both HITECH and HIPAA.
1. Administrative Duties
- Appoint a privacy officer.
- Conduct an annual risk assessment.
- Create or administer a program to train employees about HIPAA compliance.
- If needed, execute a business associate agreement with any partner or subcontractor involved in the project.
- Periodically review procedures and policies, updating as needed.
2. Technical Duties
- Require a unique user ID or number to identify and track activity on the software.
- Verify the identity of each user or entity accessing the program with an identification feature.
- An emergency access procedure is mandatory for obtaining information during an emergency.
- Include an automatic log-off after a set period of inactivity.
- Use a mechanism for encrypting and decrypting data.
- Put security measures and integrity controls in place to ensure data cannot be modified without detection for as long as the data exists.
- Provide audit controls to record activity and permit review.
- Include an electronic mechanism to authenticate protected health information and ensure it is not subjected to unauthorized deletions or alterations.
3. Physical Safeguards
- A required disaster recovery and contingency operations plan.
- Policies and procedures in place to protect the facility and information stored there from unauthorized physical access, theft, or tampering.
- Restrict access to development or testing data to only those with a validated need for access.
- Document all modifications or repairs to the facility that could affect physical security (such as locks, doors, or hardware).
- Implement disposal policies and procedures for electronic media and storage devices.
- Maintain records of the movement of hardware (such as servers) and media (such as flash drives).
- If equipment must be moved, providers must first make a complete and retrievable copy of the data.
- Secure workstations so only authorized users can access them.
- Set policies and procedures that define which functions can be performed on a workstation, how functions must be performed, and the physical attributes of an individual workstation or category of workstations.
Best Practices in Outsourcing Healthcare Software Development
Primarily, you should ensure your outsourcing partner can meet HIPAA requirements. But that alone doesn’t mean a developer is reliable and capable. Equally important is how professional, skilled, and dedicated the outsourcing partner is when handling your project.
Consequently, you may look for additional indicators that help you feel confident in your outsourced healthcare software developer.
- Security: Require two-factor authentication, such as swiping a badge and entering a code, to access protected data.
- Video surveillance: Maintain video logs for a minimum of three months.
- Visitors’ log: Require visitors to sign in. Audits should confirm a direct match between the video logs and the visitors’ log.
- Documented procedures: Consistently document policies and procedures. Employees should give consistent answers to questions about specific policies or procedures.
There is no concept of safe harbor in HIPAA.
It does not matter whether you accidentally transmit data to an unauthorized recipient, allow an unauthorized employee to access protected health information, or fail to maintain proper system security against hackers. You can face hefty fines of up to $50,000 for each record or violation. In some cases, you could even face criminal charges.
Therefore, it is essential that you ensure that your company is fully compliant with HIPAA. Additionally, this includes any associates or subcontractors you use.
Find a Reliable Healthcare Software Development Team You Can Trust
At Xperity, we take security very seriously. Our healthcare software development facilities employ qualified third-party services to continuously audit and ensure HIPAA compliance. Staff members receive extensive training to make sure that the facility, equipment, and all of our clients’ data receive the protection that confidential information requires.
Partner with an outsourcing team that prioritizes security and compliance for your organization. Learn more about outsourcing healthcare software development projects with Xperity by contacting our team!
