The healthcare sector is under increasing pressure. While electronic health records (EHRs), telemedicine, AI, and other healthtech innovations are transforming healthcare delivery, they also amplify the risk of data breaches and regulatory violations.
In 2024 alone, over 276 million individuals’ protected health information (PHI) was exposed or stolen, according to the Office of Civil Rights (OCR).
The average cost of a breach in U.S. healthcare is nearly $10 million, one of the highest costs across all industries.
Meanwhile, regulatory bodies have been actively imposing penalties: HIPAA fines in 2025 range from several thousand to over $2 million, depending on severity. A high number of these violations involve willful neglect.
For SMBs operating in healthcare who are applying for contract awards or seeking partnerships, this article will provide useful insights on how to implement proper information security practices and maintain cybersecurity compliance in healthcare.
Critical healthcare cybersecurity regulations
Cybersecurity compliance in healthcare refers to the policies and procedures organizations must put in place to protect PHI. It also involves demonstrating adherence to all relevant regulations and standards. It ensures that healthcare providers and their business associates safeguard patient data, reduce operational and financial risk, and maintain trust in an increasingly digital care environment.
All organizations handling ePHI are required to comply with HIPAA and HITECH. While there is no formal HIPAA compliance certification, healthcare organizations often choose (or are required to) demonstrate their compliance with HIPAA through formal audits and certifications. The most common ones are HITRUS and SOC 2 + HIPAA.
HIPAA & HITECH
HIPAA (Health Insurance Portability and Accountability Act) was enacted in 1996 to establish national standards for protecting sensitive patient health information (PHI) by ensuring the confidentiality, integrity, and availability of electronic PHI (ePHI). It aims to safeguard privacy, security, prevent fraud, and ensure the portability of health information. HIPAA is a federal law, meaning compliance is mandatory for all covered entities. This includes healthcare providers, health plans, clearinghouses, and any business associates that handle PHI within the U.S. healthcare system.
HIPAA was originally enacted without accounting for the rapid expansion of the internet and web-based applications, leaving important gaps in privacy and security protections. To close those gaps, the HITECH Act (Health Information Technology for Economic and Clinical Health Act) was introduced in 2009. The Act built on HIPAA by promoting the adoption of electronic health records (EHRs) and imposing stricter breach notification rules. It also expanded HIPAA’s scope by making business associates directly liable for compliance, strengthening enforcement mechanisms, increasing penalties for violations, and elevating security requirements across the healthcare ecosystem.
HITRUST CSF
The HITRUST (Health Information Trust Alliance Common Security Framework) is a certifiable risk management framework that integrates multiple regulations and frameworks, including HIPAA, NIST, ISO 27001, and PCI DSS, into a single, scalable approach. Developed in 2007, it provides healthcare organizations with a structured methodology for managing risk and demonstrating compliance with industry security and privacy standards.
The HITRUST CSF integrates security controls across 19 domains that address critical areas such as access control, network security, incident management and response, data privacy, etc. The collection of control requirements varies based on an organization’s risk profile, regulations, and chosen assessment level.
Although HITRUST certification is not legally mandated, many healthcare organizations, payers, and providers prefer or require it for their third-party vendors.
SOC 2
SOC 2 (Service Organization Control 2) was developed by the American Institute of Certified Public Accountants (AICPA) to evaluate an organization’s ability to protect sensitive data. In the healthcare sector, SOC 2 compliance is crucial for third-party vendors handling sensitive patient data.
While not a legal requirement, many healthcare organizations mandate SOC 2 compliance to ensure their service providers implement stringent security, availability, and confidentiality controls. A SOC 2 audit verifies that an organization has implemented the required controls and complies with the Trust Services Criteria (TSC). These criteria include security (which is mandatory), as well as availability, processing integrity, confidentiality, and privacy, which are selected based on business needs.SOC 2 + HIPAA is a type of audit that addresses HIPAA requirements in addition to the standard SOC 2 objectives.
Healthcare compliance program
A healthcare compliance program involves implementing policies and procedures designed to support compliance with federal, state, local, and industry regulations. It also includes following voluntary standards in the healthcare industry, such as HIPAA, HITRUST, and SOC 2.There is no one-size-fits-all healthcare compliance program, as all organizations differ in their purpose and scope. However, the common elements of the compliance program in healthcare:
Establishing applicability and scope
First, organizations need to scope their environment to understand which regulations and standards are applicable to an organization’s activities. Scoping includes assessing the effectiveness of existing compliance measures, and developing a plan to fill the gaps in compliance and other threats or vulnerabilities.
Designate a compliance officer and/or compliance team
Several regulations (i.e., HIPAA) require healthcare organizations to designate a privacy and/or security official who has the responsibility of delivering the healthcare compliance program. This may be either a dedicated team member with applicable expertise and skills (generally with IT background) or a Chief Information Security Officer.
Ensure effective staff training and communication
Healthcare compliance training is typically split into two parts. Privacy training is provided to employees who handle sensitive information, while security awareness training is required for all members of the workforce..
Effective lines of communication are essential to a healthcare compliance program, allowing members of the workforce to be informed of policy changes and enabling compliance teams to be alerted to potential compliance violations.
Conduct internal monitoring and auditing.
It is essential to recognize that having a healthcare compliance program does not guarantee compliance. Compliance is a multifaceted activity that requires internal monitoring and auditing to ensure that people, processes, and technology are contributing to the organization’s compliance activities as expected.
Common compliance challenges for healthcare organizations
Organizations operating in the U.S. healthcare market face numerous challenges that significantly complicate medical compliance.
Legacy systems
A study of 2021 reports that 73% of healthcare organizations still use legacy information systems. This makes integration, patching, and monitoring very difficult while complicating timely breach detection or secure data sharing. And there is proof: IBM’s 2025 Cost of a Data Breach report placed U.S. healthcare at an average breach cost of US$9.77 million, the highest across all industries. Much of the added cost is due to legacy IT environments that are complex to maintain, difficult to secure, and costly to recover.
Insufficient staff training and awareness
Furthermore, staff training and awareness are often insufficient. Even when cybersecurity policies exist on paper, human error, such as falling for phishing scams or misconfiguring access, remains a significant cause of data breaches. Generally, health staff have poor awareness of the consequences of certain behaviors, and a lack of policies and reinforcement of secure behavior is a common occurrence.
Complex vendor ecosystem & third-party risks
In healthcare, third-party cybersecurity risks arise from external service providers whose inadequate information security and compliance practices can lead to data breaches, operational disruptions, as well as financial and reputational losses.
The 2024 ransomware attack on Change Healthcare, a major healthtech company serving healthcare organizations with various services and solutions, stands as a landmark example. This single, yet sophisticated attack caused massive disruption to healthcare providers across the US for several weeks and compromised approximately 190 million individuals' data. The consequences of such a breach include reputational damage and steep fines for HIPAA non-compliance.
Resource constraints
Although healthtech organizations strive to deliver uninterrupted healthcare services, the necessary emphasis is not given to the security aspect in terms of upkeep (e.g., keeping software updated and systems secure). The problem is compounded by a shortage of skilled cybersecurity professionals. According to ISC, the global cybersecurity workforce gap grew to nearly 4 million professionals, with healthcare cited among the most heavily impacted sectors. This shortage leaves many organizations unable to maintain operations at the required pace without compromising security assurance. Many hospitals and health systems operate on thin margins, forcing leadership to prioritize clinical care over IT investments. As a result, cybersecurity and compliance budgets remain limited.
Rapidly changing technology and regulatory environment
Keeping up with compliance is becoming harder as technologies and rules evolve quickly. In January 2025, the HHS proposed significant updates to the HIPAA Security Rule. The changes include stronger encryption requirements, stricter risk analysis requirements, and the implementation of multi-factor authentication. At the same time, HITRUST CSF released version 11.5.0 in April 2025, expanding and refining its control set across 19 domains. For healthcare organizations, especially those already strained by resource constraints and legacy IT systems, this constant shift in requirements makes it increasingly difficult to stay compliant while maintaining day-to-day operations.
Best practices for achieving and maintaining compliance
Given the increasing complexity of the cybersecurity landscape in healthcare, organizations must enhance their approaches to protecting patient data and maintaining regulatory compliance. While the compliance recommendations and approaches vary depending on the organization, some common best practices for healthcare compliance still exist:
- Conduct comprehensive risk assessments. Assess risks associated with data handling and using healthtech devices, including cloud-based EHRs and AI systems. Identify potential vulnerabilities and implement measures to mitigate them.
- Invest in necessary security measures. Implement encryption, access control, and intrusion detection systems to protect ePHI. Ensure that all third-party vendors who touch sensitive healthcare data adhere to the necessary requirements. Ensure that your agreements clearly specify the responsibilities of each party.
- Enhance employee training. Ensure that all employees are trained in cybersecurity best practices. This includes recognizing phishing attempts, securing mobile devices, and understanding the importance of data protection.
- Strengthen compliance efforts. Stay informed about changes to HIPAA, SOC 2, HITRUST and other relevant regulations and standards. Regularly review and update policies and procedures to ensure ongoing compliance, particularly when adopting new technologies, experiencing a data breach or reorganizing your company.
- Develop an incident response plan. Having a comprehensive and functional incident response plan will enable the organization to swiftly identify, isolate, and eradicate security breaches. The plan will govern how security incidents are handled and will also document key stakeholders and escalation procedures.
Maintain cybersecurity compliance in healthcare with Planet 9
Planet 9 is your cybersecurity and compliance partner who helps navigate critical healthcare cybersecurity standards and regulations and helps achieve and sustain HIPAA, HITRUST, and SOC 2 certifications.
Planet 9 compliance services offer a comprehensive approach to ensuring and maintaining healthcare compliance, which includes:
- Conducting a discovery to understand the client’s organization, business processes, and technologies.
- Performing a HIPAA evaluation to identify safeguards in place and compliance gaps.
- Performing a risk assessment to identify risks to PHI.
- Developing a roadmap for addressing the identified compliance gaps and risks
- Assisting the client in executing the roadmap.
You can also utilize the Planet 9 HIPAA Vitals application to assess your HIPAA compliance. The HIPAA Vitals assessment is based on several reputable sources, including the Office of Civil Rights (OCR) Audit Protocol, NIST 800-66 Rev. 1, HIPAA Security Series issued by the Department of Health and Human Services (DHHS), and years of experience implementing HIPAA requirements in different organizations by our professionals.
Feel free to contact the Planet 9 team for help with your security and compliance challenges. We’ll be happy to assist!
Website: https://planet9security.com
Email: info@planet9security.com
Phone: 888-437-3646
