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The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) are two major U.S. federal laws designed to safeguard patient information. They are often referenced together in healthcare data privacy discussions, each serving a distinct purpose.
Since HIPAA and HITECH address unique yet complementary challenges in protecting sensitive health information, it can be confusing to confidently grasp the distinction between them.
This HIPAA vs. HITECH guide breaks down their overlaps and differences. You’ll know what each law means for your organization's compliance obligations and how to leverage it to build a resilient, patient-trusted data protection strategy.
What is HIPAA?
Enacted in 1996, HIPAA became the first U.S. law to establish federal standards for securing and handling protected health information (PHI).
PHI refers to any individually identifiable health information that is created, stored, or transmitted by a covered entity—organizations required to comply with HIPAA—or their business associates in connection with medical treatment, healthcare operations, or payment for healthcare services.
HIPAA has been expanded by additional rules, such as the Privacy and Security Rule that define how PHI must be handled, secured, and disclosed. While HIPAA contains additional rules, three essential rules form the foundation:
- Privacy Rule: Establishes guidelines for how PHI can be used or disclosed and defines individuals’ rights over their data. One of the core principles of this rule is the Minimum Necessary Rule, which demands that only the PHI needed for a given task be used or disclosed.
- Security Rule: Focuses on protecting electronic PHI (ePHI) by requiring healthcare organizations to implement specific administrative, physical, and technical safeguards.
- Breach Notification Rule: Requires covered entities to notify affected individuals, regulatory bodies, and sometimes even the media when PHI is compromised.
HIPAA also contains other rules, such as the Omnibus Rule and Enforcement Rule, which address other procedural and integration aspects of the law.
HIPAA compliance is mandatory for in-scope entities, including covered entities and their business associates. The table below outlines some examples:
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
What is HITECH?
The HITECH Act was enacted in 2009 as a part of the American Recovery and Reinvestment Act. Its primary purpose was to strengthen HIPAA’s Privacy and Security rules by encouraging healthcare organizations to adopt electronic health records (EHRs).
To support this shift, the Department of Health and Human Services (HHS) initially launched the Meaningful Use program in 2011 to incentivize care providers who implement EHRs. Those who adopted and demonstrated meaningful use of certified EHRs were rewarded financially. Some of the program’s aims were:
- Improved care coordination
- Increased efficiency
- Reduced costs
- Improved public health
- Increased involvement of patients and their caregivers in their healthcare
However, the Meaningful Use program officially ended for Medicare providers in 2018, and for Medicaid in 2021. The initiative has been replaced by the Promoting Interoperability program to continue guiding EHR best practices, with a special focus on interoperability and improving patient access to health information.
HITECH also laid the foundation for Health Information Exchanges (HIE), which enable secure, electronic sharing of EHR between providers, systems, and organizations. HIEs are systems that improve care coordination by allowing healthcare providers and patients to safely access and share critical medical information electronically.
One of HITECH's more significant contributions is that it strengthened HIPAA through amendments that expanded the enforcement scope, leading to an increase in non-compliance penalties. Now, patients must also be notified if their unsecured PHI is accessed, used, or disclosed without authorization, giving them more visibility and control over their data.
What do HIPAA and HITECH have in common?
The core feature of both HIPAA and HITECH is protecting the security and integrity of PHI, whether in physical or electronic form.
Another feature they share is outlining specific corrective actions in case of non-compliance. These can result in legal and financial penalties, depending on the nature and severity of the offense.
What are the differences between HIPAA and HITECH?
The distinctions between HIPAA and HITECH boil down to five areas:
- Scope
- Evolving role of business associates
- Penalties and fines
- Breach notification timelines
- Patient rights
1. Scope
HIPAA is the most important federal law in healthcare that governs the security and integrity of PHI. While its scope didn’t always include today’s digital-first environment, its rules have been adapted to support modern data protection needs.
HITECH builds on HIPAA’s foundation to support digital transformation and related accountability in healthcare ecosystems.
“
With the expansion of information technology, HITECH extended HIPAA’s scope to apply to business associates of covered entities, introduced breach notification requirements, and imposed stricter penalties for HIPAA violations.”
Through its Privacy and Security Rules, HIPAA sets standards for the handling and safeguarding of both physical PHI, such as physical patient records, and ePHI, such as electronic health records.
On the other hand, HITECH puts a greater focus on ePHI. It was introduced to encourage healthcare providers to adopt EHRs and outlines financial incentives for organizations transitioning from paper-based systems to electronic ones.
2. Evolving role of business associates
HIPAA originally defined the role of business associates as entities that handle PHI on behalf of covered entities. However, it did not require these associates to comply with HIPAA rules directly. Moreover, the Privacy Rule did not enforce the use of business associate agreements (BAAs) at all.
HITECH changed the status quo in 2009 by expanding HIPAA’s reach to include business associates as directly accountable entities complying with HIPAA rules. HITECH also made BAAs legally enforceable and introduced penalties for non-compliance. The update ensured business associates had a more active role in the healthcare data security ecosystem.
In effect, HITECH made business associates equally responsible for protecting PHI as covered entities—it’s not only a contractual obligation but also a federal guideline.
3. Penalties and fines
Under HIPAA’s original framework, penalties for non-compliance were minimal and rarely enforced. At the time, the fines were about $100 per violation with an annual cap of $25,000. Another blocker was that the Department of Health and Human Services’ Office for Civil Rights (OCR), which oversees enforcement, often lacked the resources to investigate violations.
This changed with the introduction of HITECH, as it drastically increased the potential consequences for non-compliance. It increased the cap and introduced a tiered penalty structure based on the level of negligence and whether timely corrective actions were taken.
The amended penalty structure is as follows:
4. Breach notification timelines
Before 2009, HIPAA did not require healthcare providers or organizations to notify patients or the government when a PHI breach occurred. Instead, breach notifications were governed by state-specific laws, such as California’s Data Breach Notification Law mandating that a business or state agency inform the affected resident in case of a breach.
HITECH closed this gap by introducing the Breach Notification Rule, which was later incorporated into HIPAA. The rule clearly defines what constitutes a breach and sets mandatory reporting timelines that organizations must follow based on the scale and severity of the breach. Failing to comply with these requirements is considered a HIPAA violation and may result in significant penalties.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
5. Patient rights
HIPAA laid the foundation for safeguarding patient information, including requirements for documenting PHI disclosures. However, it initially did not give patients access to these records and disclosures.
The patient rights were granted in 2011, when HHS made an amendment to HITECH, allowing individuals to request an “accounting of disclosures” report from their healthcare providers. For complete transparency, these reports had to include the following information:
- The date of disclosure
- The recipient of the PHI
- A brief description of the information provided
- The purpose of the disclosure
This amendment increased the accountability of healthcare providers and their business associates toward patients. Since patients can now request such records, covered entities have to maintain accurate, accessible disclosure logs.
Should you prioritize HIPAA or HITECH compliance?
Both HIPAA and HITECH are mandatory frameworks, so non-compliance with either can lead to potential fines and legal penalties.
The good news is that the complementary nature of the two frameworks makes the compliance workflows more manageable than it might seem. Many HITECH provisions are extensions or additions to HIPAA that merely strengthen the existing safeguards around ePHI. That’s why most organizations start with HIPAA compliance, as it allows them to integrate HITECH requirements naturally over time.
Furthermore, treating HIPAA as your compliance foundation helps you implement industry-standard controls and strengthen your security posture, often with greater efficiency and ROI.
Potential challenges of pursuing HIPAA compliance
HIPAA demands rigorous technical, administrative, and physical safeguards, so it’s common to face challenges such as:
- Continuous monitoring: Organizations must continually track systems that store, process, and transmit PHI to be able to detect and respond to security incidents. This type of monitoring can drain internal resources.
- Extensive documentation and evidence collection: Organizations must keep thorough and up-to-date documentation of their policies, procedures, employee training, and security measures, which can divert attention from core operations.
- Regular risk assessments and audits: HIPAA requires that organizations regularly assess security risks and vulnerabilities. These audits must be comprehensive and documented, which can be challenging for overstretched internal teams.
- Potential regulatory changes: HIPAA regulations and enforcement standards can evolve, and missing updates could mean costly non-compliance.
- Third-party risk management: Even after managing third-party risks via BAAs, the risks in your vendor risk landscape are not always visible. So, some vulnerabilities can still go unaddressed.
Teams can mitigate many of these challenges by leveraging automation tools like Vanta to streamline the compliance process. Such tools can monitor risks in real time, collect required evidence to demonstrate compliance, and simplify creating BAAs, among other tasks.
Streamline HIPAA compliance with Vanta
Vanta is a leading compliance and trust management platform that streamlines achieving and maintaining HIPAA compliance. With its out-of-the-box HIPAA product, you can automate up to 85% of evidence collection and get step-by-step guidance on how to meet the regulations’ requirements.
Vanta can highlight gaps in your compliance posture, suggest remediation strategies, and ultimately automate the process. You can also access 35+ other compliance frameworks such as SOC 2 and ISO 27001, as well as custom frameworks for your unique regulatory landscape.
Vanta’s HIPAA solution offers many time-saving capabilities that support your path to compliance, including:
- Real-time monitoring and instant security reports
- Pre-built policy templates
- Integration with over 375 business tools to collect evidence
- A unified dashboard for tracking everything related to HIPAA
- Built-in training solutions
- Creating and tracking BAAs
With Vanta, you can also build custom frameworks tailored to your compliance program. For instance, you can add custom HITECH controls over the platform’s built-in HIPAA controls and save time managing multiple frameworks and standards.
You can schedule a custom demo to get a personalized overview of how Vanta can support your business.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Additional resources
HIPAA vs. HITECH: Differences and similarities explained
Looking to streamline the work for HIPAA compliance?
The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) are two major U.S. federal laws designed to safeguard patient information. They are often referenced together in healthcare data privacy discussions, each serving a distinct purpose.
Since HIPAA and HITECH address unique yet complementary challenges in protecting sensitive health information, it can be confusing to confidently grasp the distinction between them.
This HIPAA vs. HITECH guide breaks down their overlaps and differences. You’ll know what each law means for your organization's compliance obligations and how to leverage it to build a resilient, patient-trusted data protection strategy.
What is HIPAA?
Enacted in 1996, HIPAA became the first U.S. law to establish federal standards for securing and handling protected health information (PHI).
PHI refers to any individually identifiable health information that is created, stored, or transmitted by a covered entity—organizations required to comply with HIPAA—or their business associates in connection with medical treatment, healthcare operations, or payment for healthcare services.
HIPAA has been expanded by additional rules, such as the Privacy and Security Rule that define how PHI must be handled, secured, and disclosed. While HIPAA contains additional rules, three essential rules form the foundation:
- Privacy Rule: Establishes guidelines for how PHI can be used or disclosed and defines individuals’ rights over their data. One of the core principles of this rule is the Minimum Necessary Rule, which demands that only the PHI needed for a given task be used or disclosed.
- Security Rule: Focuses on protecting electronic PHI (ePHI) by requiring healthcare organizations to implement specific administrative, physical, and technical safeguards.
- Breach Notification Rule: Requires covered entities to notify affected individuals, regulatory bodies, and sometimes even the media when PHI is compromised.
HIPAA also contains other rules, such as the Omnibus Rule and Enforcement Rule, which address other procedural and integration aspects of the law.
HIPAA compliance is mandatory for in-scope entities, including covered entities and their business associates. The table below outlines some examples:
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
What is HITECH?
The HITECH Act was enacted in 2009 as a part of the American Recovery and Reinvestment Act. Its primary purpose was to strengthen HIPAA’s Privacy and Security rules by encouraging healthcare organizations to adopt electronic health records (EHRs).
To support this shift, the Department of Health and Human Services (HHS) initially launched the Meaningful Use program in 2011 to incentivize care providers who implement EHRs. Those who adopted and demonstrated meaningful use of certified EHRs were rewarded financially. Some of the program’s aims were:
- Improved care coordination
- Increased efficiency
- Reduced costs
- Improved public health
- Increased involvement of patients and their caregivers in their healthcare
However, the Meaningful Use program officially ended for Medicare providers in 2018, and for Medicaid in 2021. The initiative has been replaced by the Promoting Interoperability program to continue guiding EHR best practices, with a special focus on interoperability and improving patient access to health information.
HITECH also laid the foundation for Health Information Exchanges (HIE), which enable secure, electronic sharing of EHR between providers, systems, and organizations. HIEs are systems that improve care coordination by allowing healthcare providers and patients to safely access and share critical medical information electronically.
One of HITECH's more significant contributions is that it strengthened HIPAA through amendments that expanded the enforcement scope, leading to an increase in non-compliance penalties. Now, patients must also be notified if their unsecured PHI is accessed, used, or disclosed without authorization, giving them more visibility and control over their data.
What do HIPAA and HITECH have in common?
The core feature of both HIPAA and HITECH is protecting the security and integrity of PHI, whether in physical or electronic form.
Another feature they share is outlining specific corrective actions in case of non-compliance. These can result in legal and financial penalties, depending on the nature and severity of the offense.
What are the differences between HIPAA and HITECH?
The distinctions between HIPAA and HITECH boil down to five areas:
- Scope
- Evolving role of business associates
- Penalties and fines
- Breach notification timelines
- Patient rights
1. Scope
HIPAA is the most important federal law in healthcare that governs the security and integrity of PHI. While its scope didn’t always include today’s digital-first environment, its rules have been adapted to support modern data protection needs.
HITECH builds on HIPAA’s foundation to support digital transformation and related accountability in healthcare ecosystems.
“
With the expansion of information technology, HITECH extended HIPAA’s scope to apply to business associates of covered entities, introduced breach notification requirements, and imposed stricter penalties for HIPAA violations.”
Through its Privacy and Security Rules, HIPAA sets standards for the handling and safeguarding of both physical PHI, such as physical patient records, and ePHI, such as electronic health records.
On the other hand, HITECH puts a greater focus on ePHI. It was introduced to encourage healthcare providers to adopt EHRs and outlines financial incentives for organizations transitioning from paper-based systems to electronic ones.
2. Evolving role of business associates
HIPAA originally defined the role of business associates as entities that handle PHI on behalf of covered entities. However, it did not require these associates to comply with HIPAA rules directly. Moreover, the Privacy Rule did not enforce the use of business associate agreements (BAAs) at all.
HITECH changed the status quo in 2009 by expanding HIPAA’s reach to include business associates as directly accountable entities complying with HIPAA rules. HITECH also made BAAs legally enforceable and introduced penalties for non-compliance. The update ensured business associates had a more active role in the healthcare data security ecosystem.
In effect, HITECH made business associates equally responsible for protecting PHI as covered entities—it’s not only a contractual obligation but also a federal guideline.
3. Penalties and fines
Under HIPAA’s original framework, penalties for non-compliance were minimal and rarely enforced. At the time, the fines were about $100 per violation with an annual cap of $25,000. Another blocker was that the Department of Health and Human Services’ Office for Civil Rights (OCR), which oversees enforcement, often lacked the resources to investigate violations.
This changed with the introduction of HITECH, as it drastically increased the potential consequences for non-compliance. It increased the cap and introduced a tiered penalty structure based on the level of negligence and whether timely corrective actions were taken.
The amended penalty structure is as follows:
4. Breach notification timelines
Before 2009, HIPAA did not require healthcare providers or organizations to notify patients or the government when a PHI breach occurred. Instead, breach notifications were governed by state-specific laws, such as California’s Data Breach Notification Law mandating that a business or state agency inform the affected resident in case of a breach.
HITECH closed this gap by introducing the Breach Notification Rule, which was later incorporated into HIPAA. The rule clearly defines what constitutes a breach and sets mandatory reporting timelines that organizations must follow based on the scale and severity of the breach. Failing to comply with these requirements is considered a HIPAA violation and may result in significant penalties.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
5. Patient rights
HIPAA laid the foundation for safeguarding patient information, including requirements for documenting PHI disclosures. However, it initially did not give patients access to these records and disclosures.
The patient rights were granted in 2011, when HHS made an amendment to HITECH, allowing individuals to request an “accounting of disclosures” report from their healthcare providers. For complete transparency, these reports had to include the following information:
- The date of disclosure
- The recipient of the PHI
- A brief description of the information provided
- The purpose of the disclosure
This amendment increased the accountability of healthcare providers and their business associates toward patients. Since patients can now request such records, covered entities have to maintain accurate, accessible disclosure logs.
Should you prioritize HIPAA or HITECH compliance?
Both HIPAA and HITECH are mandatory frameworks, so non-compliance with either can lead to potential fines and legal penalties.
The good news is that the complementary nature of the two frameworks makes the compliance workflows more manageable than it might seem. Many HITECH provisions are extensions or additions to HIPAA that merely strengthen the existing safeguards around ePHI. That’s why most organizations start with HIPAA compliance, as it allows them to integrate HITECH requirements naturally over time.
Furthermore, treating HIPAA as your compliance foundation helps you implement industry-standard controls and strengthen your security posture, often with greater efficiency and ROI.
Potential challenges of pursuing HIPAA compliance
HIPAA demands rigorous technical, administrative, and physical safeguards, so it’s common to face challenges such as:
- Continuous monitoring: Organizations must continually track systems that store, process, and transmit PHI to be able to detect and respond to security incidents. This type of monitoring can drain internal resources.
- Extensive documentation and evidence collection: Organizations must keep thorough and up-to-date documentation of their policies, procedures, employee training, and security measures, which can divert attention from core operations.
- Regular risk assessments and audits: HIPAA requires that organizations regularly assess security risks and vulnerabilities. These audits must be comprehensive and documented, which can be challenging for overstretched internal teams.
- Potential regulatory changes: HIPAA regulations and enforcement standards can evolve, and missing updates could mean costly non-compliance.
- Third-party risk management: Even after managing third-party risks via BAAs, the risks in your vendor risk landscape are not always visible. So, some vulnerabilities can still go unaddressed.
Teams can mitigate many of these challenges by leveraging automation tools like Vanta to streamline the compliance process. Such tools can monitor risks in real time, collect required evidence to demonstrate compliance, and simplify creating BAAs, among other tasks.
Streamline HIPAA compliance with Vanta
Vanta is a leading compliance and trust management platform that streamlines achieving and maintaining HIPAA compliance. With its out-of-the-box HIPAA product, you can automate up to 85% of evidence collection and get step-by-step guidance on how to meet the regulations’ requirements.
Vanta can highlight gaps in your compliance posture, suggest remediation strategies, and ultimately automate the process. You can also access 35+ other compliance frameworks such as SOC 2 and ISO 27001, as well as custom frameworks for your unique regulatory landscape.
Vanta’s HIPAA solution offers many time-saving capabilities that support your path to compliance, including:
- Real-time monitoring and instant security reports
- Pre-built policy templates
- Integration with over 375 business tools to collect evidence
- A unified dashboard for tracking everything related to HIPAA
- Built-in training solutions
- Creating and tracking BAAs
With Vanta, you can also build custom frameworks tailored to your compliance program. For instance, you can add custom HITECH controls over the platform’s built-in HIPAA controls and save time managing multiple frameworks and standards.
You can schedule a custom demo to get a personalized overview of how Vanta can support your business.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
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