Is FISMA required for HIPAA compliant software?

FISMA is not universally required for software that is HIPAA compliant, but it becomes relevant when federal contracts or data handling obligations are involved. The decision to pursue adherence to FISMA depends on the organization’s operational context and contractual requirements.

What is FISMA? 

FISMA, enacted in 2002 as part of the Electronic Government Act, is designed to ensure the information security within federal agencies and their contractors. According to a Rochester Educational paper on the topic, “In the context of FISMA, the term ‘information security’ means protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to ensure the confidentiality, integrity, and availability of the data.”

It requires that federal agencies develop, document, and implement comprehensive information security programs that protect the confidentiality, integrity, and availability of their information systems. This triad, confidentiality, integrity, and availability, is central to FISMA’s approach to information security.

FISMA’s purview goes beyond federal agencies, which means that organizations working under federal contracts must also comply with its requirements. The act requires agencies to take measures like conduct risk assessments, implement security controls based on those risks, and report annually on their security posture to the Office of Management and Budget (OMB) and Congress. The National Institute of Standards and Technology (NIST) is responsible for FISMA compliance by providing detailed guidelines and standards, such as the NIST Special Publication 800 series.

How the compliance process works 

The FISMA compliance process is a structured, multi-step lifecycle designed to ensure that federal information systems are adequately protected throughout their operational life. The Sensors (Basel) study ‘’ provides insight into the compliance process, stating, “Federal agencies are required to ensure continuous system monitoring and each agency receives annual grade on FISMA compliance [40];”

• It begins with identifying and categorizing information systems based on their impact on confidentiality, integrity, and availability, following the Federal Information Processing Standards (FIPS) 199 guidelines. The categorization helps agencies determine the level of security controls necessary for each system according to its risk profile.
• Once systems are categorized, agencies select baseline security controls from the NIST Special Publication 800-53. These controls are tailored to the system’s risk level and refined through risk assessments that consider threats, vulnerabilities, and potential impacts. The selected controls are then implemented to mitigate identified risks.
• Following implementation, the next step is the assessment of security controls. It involves testing and evaluating whether the controls are effective and operating as intended. Independent assessors or internal security teams conduct these assessments, identifying any gaps or weaknesses in the system. Based on the assessment results, agencies must address deficiencies through corrective actions to enhance security measures.
• After successful assessment, the system undergoes an authorization process, where a designated official reviews the security documentation and assessment results to decide whether the system’s risk level is acceptable for operation. The formal authorization is known as the Authority to Operate (ATO) and is a prerequisite for the system to go live or continue operating.
  
  

Why is FISMA useful for HIPAA compliant software organizations 

Chapter 2: Research Environment from the Agency for Healthcare Research and Quality (US) notes, “Most regulatory security frameworks, such as the Health Information Portability and Accountability Act (HIPAA) and Federal Information Security Management Act (FISMA), focus on controlling the confidentiality, integrity, and availability of information.”

FISMA is useful for HIPAA compliant software organizations interested in working with federal agencies and associated organizations. While HIPAA focuses on protecting patient health data within the healthcare sector, FISMA’s security controls and risk management processes offer a form of accountability. Through its alignment with NIST standards, it offers detailed guidance on implementing these protections systematically. 

Organizations that comply with FISMA are likely to have mature security programs that address many HIPAA security rule requirements. 

The challenges that come with achieving FISMA compliance 

According to the Journal of Biomedical Information study ‘Towards a Privacy Preserving Cohort Discovery Framework for Clinical Research Networks’ which looks at data privacy in accordance to relevant legislation, “Health IT professionals and health practitioners often assume the data are sufficiently secure when they live in a data center that meets compliance responsibilities (e.g., the HIPAA Security Rule22 and FISMA32).”

A challenge in acquiring adherence to FISMA is managing the increased security controls and documentation. FISMA requires detailed categorization of information systems, formal risk assessments, implementation of a wide range of controls, continuous monitoring, and annual reporting to federal oversight bodies. The level of rigor demands administrative effort and technical expertise. The need to maintain extensive documentation and perform regular assessments can strain organizations, especially smaller vendors or those without dedicated compliance teams.

Another challenge is reconciling differences in privacy and security approaches. HIPAA’s privacy rule restricts the use and disclosure of identifiable health information. FISMA, while also concerned with confidentiality, places a strong emphasis on system-wide security controls and risk management applicable to all federal information systems. This can create conflicts or redundancies in how data protection policies are instilled. 

Is FISMA worth it?

Adhering to FISMA is worth it for HIPAA-compliant software like Paubox if federal contracts or data handling obligations exist, or if the organization seeks to demonstrate superior security assurance. FISMA’s structured risk management approach and continuous monitoring processes help organizations maintain robust defenses against cyber threats. 

It improves trust and competitive advantage in markets where federal contracts or grants are involved. For platforms like Paubox that specialize in HIPAA compliant email and communication solutions for healthcare, FISMA compliance can serve as a differentiator by showcasing adherence to stringent federal standards.

The decision to pursue compliance with the regulations of FISMA should consider the associated costs and resource commitments. Implementing and maintaining FISMA controls requires investment in security infrastructure, personnel, and compliance management. For organizations that do not work directly with federal agencies or whose clients do not require FISMA, the benefits may not justify the costs.

FAQs

What types of federal contracts are available for software platforms?

Software platforms typically engage in fixed-price contracts, cost-reimbursement contracts, and time-and-materials contracts. Fixed-price contracts pay a set amount upon delivery, cost-reimbursement contracts cover allowable expenses with oversight, and time-and-materials contracts bill based on hours worked and materials used.

What is the typical federal government contracting process for software providers?

The process begins with the pre-award phase, including needs identification and solicitation (RFPs or RFQs), followed by contract award and negotiation. Post-award, contract management involves monitoring deliverables, compliance, amendments, and renewals under close scrutiny.

What are the compliance requirements for federal software contracts?

Contracts often require adherence to federal regulations such as FAR, cybersecurity standards (e.g., NIST frameworks), audit trails, and documentation of approvals.

How can contract management software help with federal contracts?

Automation tools streamline contract approvals, reduce manual errors, maintain audit trails, and improve compliance. For example, digital workflows can shorten approval times from weeks to days and provide searchable, timestamped records for audits.