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HIPAA Gets a Potential Counterpart in HISAA

Americans hear about cybersecurity incidents on a frequent basis. As the adage goes, it is not a matter of “if” a breach or security hack occurs; it is a matter of “when.” At no time was that more evident earlier this year when the healthcare industry was hit with the widespread ransomware attack on Change Healthcare, a subsidiary of the United Health Group. Because of the nature of the Change Healthcare shutdown and its impact across the industry, the U.S. Department of Health & Human Services (HHS) and its HIPAA enforcement arm, the Office for Civil Rights (OCR), conducted investigations and issued FAQ responses for those impacted by the cybersecurity event.

In further response, Senators Ron Wyden (D-OR) and Mark Warner (R-VA) introduced the Health Infrastructure Security and Accountability Act (HISAA) on September 26, 2024. Like HIPAA and HITECH before it, which established minimum levels of protection for healthcare information, HISAA looks to reshape how healthcare organizations address cybersecurity by enacting mandatory minimum security standards to protect healthcare information and by providing initial financial support to facilitate compliance. A copy of the legislative text can be found here, and a one-page summary of the bill can be found here.

To date, HIPAA and HITECH require covered entities and business associates to develop, implement, and maintain reasonable and appropriate “administrative, technical, physical” safeguards to protect electronic Protected Health Information or e-PHI. However, the safeguards do not specify minimum requirements; instead, they prescribe standards intended to be scalable, depending on the specific needs, resources, and capabilities of the respective organization. What this means is that e-PHI stored or exchanged among interconnected networks are subject to systems with often different levels of sophistication or protection.

Given the considerable time, effort, and resources dedicated to HIPAA/HITECH compliance, many consider the current state of voluntary safeguards as inadequate. This is especially the case since regulations under the HIPAA Security Rule have not been updated since 2013. As a result, Senators Wyden and Warner introduced HISAA in an effort to bring the patchwork of healthcare data security standards under one minimum umbrella and to require healthcare organizations to remain on top of software systems and cybersecurity standards.

Key pieces of HISAA, as proposed, include:

Mandatory Cybersecurity Standards—If enacted, the Secretary of HHS, together with the Director of the Cybersecurity and Infrastructure Security Agency (CISA) and the Director of National Intelligence (DNI), will oversee the development and implementation of required standards and the standards will be subject to review and update every two years to counter evolving threats.
Annual Audits and Stress Tests—Like current Security Risk Assessment (SRA) requirements, HISAA will require healthcare organizations to conduct annual cybersecurity audits and document the results. Unlike current requirements, these audits will need to be conducted by independent organizations to assess compliance, evaluate restoration abilities, and conduct stress tests in real-world simulations. While smaller organizations may be eligible for waivers from certain requirements because of undue burden, all healthcare organizations will have to publicly disclose compliance status as determined by these audits.
Increased Accountability and Penalties—HISAA would implement significant penalties for non-compliance and would require healthcare executives to certify compliance on an annual basis. False information in such certifications could result in criminal charges, including fines of up to $1 million and prison time for up to 10 years. HISAA would also eliminate fine caps to allow HHS to impose penalties commiserate with the level needed to deter lax behaviors, especially among larger healthcare organizations.
Financial Support for Enhancements—Because the costs for new standards could be substantial, especially for smaller organizations, HISAA would allocate $1.3 billion to support hospitals for infrastructure enhancements. Of this $1.3 billion, $800 million would be for rural and safety net hospitals over the first two years, and an additional $500 million would be available for all hospitals in succeeding years.
Medicare Payment Adjustments—Finally, HISAA enables the Secretary of HHS to provide accelerated Medicare payments to organizations impacted by cybersecurity events. HHS offered similar accelerated payments during the Change Healthcare event, and HISAA would codify similar authority to HHS for recovery periods related to future cyberattacks.

While HISAA will establish a baseline of cybersecurity requirements, compliance with those requirements will require a significant investment of time and resources in devices and operating systems/software, training, and personnel. Even with the proposed funding, this could result in substantial challenges for smaller and rural facilities to comply. Moreover, healthcare providers will need to prioritize items such as encryption, multi-factor authentication, real-time monitoring, comprehensive response and remediation plans, and robust training and exercises to support compliance efforts.

Finally, at this juncture, the more important issue is for healthcare organizations to recognize their responsibilities in maintaining effective cybersecurity practices and to stay updated on any potential changes to these requirements. Since HISAA was introduced in the latter days of a hectic (and historic) election season, we will monitor its progress as the current Congress winds down in 2024 and the new Congress readies for action with a new administration in 2025.

HHS Publishes Final Rule to Support Reproductive Health Care Privacy

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as well as the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act)—strengthens privacy protections related to the use and disclosure of reproductive health care information. HIPAA’s Privacy Rule limits the disclosure of protected health information (PHI) and is part of HHS’s efforts to ensure that patients will not be afraid to seek health care from, or share important information with, health care providers.

The Final Rule:

Prohibits the use or disclosure of PHI when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities.
Requires covered entities and business associates to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes.
Requires covered entities to modify their NPPs to support reproductive health care privacy.

“Since the fall of Roe v. Wade, providers have shared concerns that when patients travel to their clinics for lawful care, their patients’ records will be sought, including when the patient goes home,” OCR Director Melanie Fontes Rainer said in a news release. OCR administers the Privacy Rule, which requires most health care providers, health plans, health care clearinghouses (“covered entities”) and business associates to safeguard the privacy of PHI.

Commenters to an earlier notice of proposed rulemaking (“2023 NPRM”) raised concerns that PHI related to reproductive health care would be used and disclosed to expose both patients and providers to investigation and liability under state abortion laws, particularly new and revived laws. This Final Rule is intended to prohibit the disclosure of PHI related to lawful reproductive health care—a change from the current Privacy Rule where an entity is generally permitted, but not required, to disclose relevant and material information in a legitimate law enforcement inquiry.

Key Takeaways

New Category of Protected Health Information. The Final Rule changes the HIPAA Privacy Rule by defining a new category of protected health information and adds a new “prohibited use and disclosure” under the HIPAA Privacy Rule at 45 CFR 164.502—mandating that a covered entity or business associate may not use or disclose PHI:

To conduct a criminal, civil, or administrative investigation into any person for the mere act of seeking, obtaining, providing, or facilitating “reproductive health care”;
To impose criminal, civil, or administrative liability on any “person” for the mere act of seeking, obtaining, providing or facilitating “reproductive health care”; and
To identify any “person” for any of those above described purposes.

Prohibition. Under the Final Rule, HIPAA-covered entities and business associates who receive requests for protected health information must make a reasonable determination that one or more of the following conditions exists:

The reproductive health care is lawful in the state in which such health care is provided under the circumstances in which it is provided (e.g., if a resident of one state traveled to another state to receive reproductive health care, such as an abortion, that is lawful in the state where such health care was provided).
The reproductive health care is protected, required, or authorized by federal law, including the U.S. Constitution, regardless of the state in which such health care is provided (e.g., reproductive health care such as contraception is protected by the Constitution).

Presumption. Such care is presumed lawful unless the HIPAA-covered entity or business associate has

actual knowledge that the reproductive care was not lawful under the circumstances it was provided; or
factual information supplied by the requester demonstrating a substantial factual basis that the reproductive health care was not lawful under the specific circumstances in which it was provided.

Attestation Requirement. The Final Rule adds 45 CFR § 164.509(c) to require a covered entity or business associate, when it receives a request for PHI potentially related to reproductive health care, to obtain a signed attestation from the requester. However, obtaining the attestation does not relieve a covered entity or business associate from its responsibility to determine whether the reproductive health care that may be the subject of the requested information was lawful. An attestation must contain the following elements:

A description of the information requested that identifies the information in a specific fashion, including one of the following:
- The name(s) of any individual(s) whose protected health information is sought, if practicable;
- If that name is not practicable, the name(s) or other specific identification of the person(s) or class of person(s) who are requested to make the use or disclosure;
The name or other specific identification of the person(s) or class of persons to whom the covered entity is to make the requested use or disclosure;
A clear statement that the use or disclosure is not for a purpose prohibited under 45 CFR § 164.502(a)(5)(iii)(i.e., identifying any person under the newly added prohibition);
A statement that a person may be subject to criminal penalties if they use or disclose the reproductive health information improperly;
Must be in plain language and contain the elements set forth in 45 CFR § 164.509(c) (inclusion of other elements not set forth in 45 CFR § 164.509(c) is prohibited); and
Must be signed by the person requesting the disclosure (which may take an electronic format).

The Final Rule prohibits the attestation from being “combined with” any other document (yet allows additional supporting information or documentation needed for the request to be submitted with the attestation (for example, a clearly labelled subpoena). While covered entities can develop their own attestation form, to reduce the compliance burden, HHS plans to publish a model attestation form prior to the compliance date.

Notices of Policy Practices. With the new processes for using and disclosing reproductive health information, covered entities must update their Notices of Privacy Practices (NPPs) required under 45 CFR § 164.520. For purposes of this Final Rule, updates to the NPPs must describe among other things the types and uses of disclosures of PHI that are prohibited under 45 CFR 164.502(a)(5)(iii). The notice should also contain a description of the uses and disclosures for which an attestation is required under the new 45 CFR § 164.509. Further, the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs determined that this Final Rule meets the criteria in 5 USC § 804(2) for being a major rule because it is projected to have an annualized impact of more than $100,000,000 based on the number of covered entities and business associates that will have to implement these changes.

Practical Implications for HIPAA Covered Entities & Business Associates

Considering the significant changes this Final Rule introduces, there is no time like the present for covered entities and business associates to consider the compliance implications that a new category of PHI will have on existing HIPAA policies and procedures. In addition to developing and/or obtaining new attestation forms, making reasonable determinations of the lawfulness of reproductive health care and updating notices of privacy practices, privacy and security officers will likely need to evaluate the impact these changes will have on the policies that govern data dissemination, and the processes and procedures that may change as well. Covered entities and business associates will also likely want to include these changes into training for employees involved in these activities.

The Final Rule goes into effect on June 25, 2024, with a compliance date of December 23, 2024. The NPP requirements, however, take effect on February 16, 2026—consistent with OCR’s 42 CFR Part 2 Rule of February 16, 2024, so that covered entities regulated under both rules can implement changes to their NPPs at the same time.

HIPAA covered entities and business associates should consider the context and framework of the HIPAA Privacy Rule and these new modifications as they consider third-party requests for any PHI that may include reproductive health information (the current HIPAA Privacy Rule remains in effect until the new rule takes effect). If the new reproductive health prohibition is not applicable, HIPAA covered entities should still consider the fact that HIPAA otherwise permits, but does not require, them to disclose PHI under most of the HIPAA exceptions contained in 45 CFR § 164.512. Therefore, HIPAA affords covered entities the ability to protect the privacy interests of their patients, especially in the current post-Dobbs environment.

Covered entities and business associates now face the challenge of implementing these new requirements and training their workforce members on how to analyze and respond to requests that include reproductive health care information. Questions remain surrounding a covered entity or business associate’s burden of determining that the reproductive health care provided to an individual was in fact lawful. For example, if a complaint follows, does a covered entity have to account for the disclosures that are made? While the Final Rule is gender-neutral, what is the likelihood that it would be applied to men—could it? In any case, we will continue to monitor developments, including questions of how HIPAA and other privacy concerns interact with reproductive health care, in the wake of Dobbs. For more on the subject, please see our past blog on the 2023 proposed rule.

Ann W. Parks contributed to this article.

HIPAA Enforcement Continues Under Right of Access Initiative

On March 28, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the resolution of two additional cases as part of OCR’s HIPAA Right of Access Initiative.

The Right of Access Initiative was launched by OCR in 2019 “to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule” as explained by OCR. In the March 28 announcement, OCR indicated its continuing commitment to enforce compliance with the HIPAA Rules, including the “foundational” Right of Access provision. With the two most recent cases, there have now been 27 investigations and settlements under the Right of Access Initiative (see full chart below).

Nearly all of the investigations in the Right of Access Initiative involve a single individual unable to obtain a copy of some or all of their protected health information from a health care provider or to do so within the timeframe required or in accordance with fees permitted by the HIPAA Privacy Rule. In some cases, additional issues found during the investigation, such as failure to have conducted a HIPAA risk assessment or lack of HIPAA policies, are part of the settlement. In all cases, in addition to the monetary penalty, the settlement has included a Corrective Action Plan imposing various obligations, such as policy development, training, and mandatory reporting to OCR.

The Right of Access Initiative remains one of the most active areas of HIPAA enforcement. In its most recent Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance, OCR noted that right of access was the third most common issue of complaints resolved. Moreover, the Right of Access Initiative coordinates with the ONC 2020-2025 Federal HIT Strategic Plan and the goal of “Providing patients and caregivers with more robust health information.” It is a core tenant of the Federal HIT Strategic Plan that access to health information will “better support person-centered care and patient empowerment.”

Article By Allen R. Killworth and Zeina Abu-Hijleh of Epstein Becker & Green, P.C.

For more health law legal news, click here to visit the National Law Review.

U.S. Department of Education Says Title IX Protects LGBTQ Students

Yesterday, the Office of Civil Rights (OCR) for the U.S. Department of Education released a new Notice of Interpretation clarifying the Department’s position that Title IX prohibits discrimination against gay and transgender students. The interpretation, applicable to both colleges and universities and K-12 institutions which accept federal funding, follows the U.S. Supreme Court’s holding in Bostock v. Clayton County that Title VII prohibits workplace discrimination based on sexual orientation or gender identity. OCR’s announcement is a departure from the previous administration’s position, which declined to extend Title IX’s protections to transgender students. While the Notice does not have the effect of law, it signals OCR’s intentions as it enforces Title IX going forward. “We just want to double down on our expectations,” said DOE Secretary Miguel A. Cardona. “Students cannot be discriminated against because of their sexual orientation or their gender identity.”

OCR’s Notice states that its interpretation is meant to align Title VII and Title IX, acknowledging that courts regularly rely on interpretations of Title VII to inform decisions based on Title IX. The interpretation also follows a March 2021 memorandum from the U.S. Department of Justice, which similarly interpreted the Bostock decision to apply to Title IX. OCR’s announcement has been welcomed by many schools, which had been forced to juggle conflicting Title IX and Title VII standards in the wake of the Bostock decision. Still others have questioned the interpretation’s impact, including schools in locations where the interpretation is in conflict with state or local law. And OCR’s Notice expressly acknowledges that the interpretation does not change the Title IX exemption for education institutions controlled by a religious organization to the extent that the law is not consistent with the organization’s religious tenets.

OCR’s announcement comes during the summer months—as many schools are updating their policies and procedures—and while many institutions anxiously await OCR’s announcement of further guidance and regulations related to Title IX, particularly regarding further guidance regarding the 2020 Title IX regulations. The interpretation also leaves open several key questions including, for example, its impact on single sex institutions or campus affinity groups or how broadly the department will define gender identity. But as schools prepare for the 2021 fall semester, administrators should be ready to address allegations of discrimination based on sexual orientation or gender identity as part of Title IX compliance efforts.

OCR’s Notice of Interpretation may be found in its entirety here.

ARTICLE BY Amanda Norris Ames, Benita N. Jones

Beth Tyner Jones, amd Rebecca C. Fleishman of

Womble Bond Dickinson (US) LLP

For more articles on the OCR, visit the NLRCivil Rights section.

New OCR Checklist Outlines How Health Care Facilities Can Fight Cyber Extortion

As technology has advanced, cyber extortion attacks have risen, and they will continue to be a major security issue for organizations. Cyber extortion can take many forms, but it typically involves cybercriminals demanding money to stop or delay their malicious activities, which include stealing sensitive data or disrupting computer services. Health care and public health sector organizations that maintain sensitive data are often targets for cyber extortion attacks.

Ransomware is a form of cyber extortion where attackers deploy malware targeting an organization’s data, rendering it inaccessible, typically by encryption. The attackers then demand money in exchange for an encryption key to decrypt the data. Even after payment is made, organizations may still lose some of their data.

Other forms of cyber extortion include Denial of Service (DoS) and Distributed Denial of Service (DDoS) attacks. These attacks normally direct a high volume of network traffic to targeted computers so the affected computers cannot respond and are otherwise inaccessible to legitimate users. Here, an attacker may initiate a DoS or DDoS attack against an organization and demand payment to stop the attack.

Additionally, cyber extortion can occur when an attacker gains access to an organization’s computer system, steals sensitive data from the organization and threatens to publish that data. The attacker threatens revealing sensitive data, including protected health information (PHI), to coerce payment.

On January 30, 2018, the HHS Office for Civil Rights (OCR) published a checklist to assist HIPAA covered entities and business associates on how to respond to a cyber extortion attack. Organizations can reduce the chances of a cyber extortion attack by:

Implementing a robust risk analysis and risk management program that identifies and addresses cyber risks holistically, throughout the entire organization;
Implementing robust inventory and vulnerability identification processes to ensure accuracy and thoroughness of the risk analysis;
Training employees to better identify suspicious emails and other messaging technologies that could introduce malicious software into the organization;
Deploying proactive anti-malware solutions to identify and prevent malicious software intrusions;
Patching systems to fix known vulnerabilities that could be exploited by attackers or malicious software;
Hardening internal network defenses and limiting internal network access to deny or slow the lateral movement of an attacker and/or propagation of malicious software;
Implementing and testing robust contingency and disaster recovery plans to ensure the organization is capable and ready to recover from a cyber-attack;
Encrypting and backing up sensitive data;
Implementing robust audit logs and reviewing such logs regularly for suspicious activity; and
Remaining vigilant for new and emerging cyber threats and vulnerabilities.

If a cyber extortion attack does happen, organizations should be prepared to take the necessary steps to prevent any more damage. In the event of a cyber-attack or similar emergency an entity:

Must execute its response and mitigation procedures and contingency plans;
Should report the crime to other law enforcement agencies, which may include state or local law enforcement, the Federal Bureau of Investigation (FBI) and/or the Secret Service. Any such reports should not include protected health information, unless otherwise permitted by the HIPAA Privacy Rule;
Should report all cyber threat indicators to federal and information-sharing and analysis organizations (ISAOs), including the Department of Homeland Security, the HHS Assistant Secretary for Preparedness and Response, and private-sector cyber-threat ISAOs.
Must report the breach to OCR as soon as possible, but no later than 60 days after the discovery of a breach affecting 500 or more individuals, and notify affected individuals and the media unless a law enforcement official has requested a delay in the reporting. An entity that discovers a breach affecting fewer than 500 individuals has an obligation to notify individuals without unreasonable delay, but no later than 60 days after discovery; and OCR within 60 days after the end of the calendar year in which the breach was discovered.

Jenna Moran and Matthew S. Arend and Sydney N. Pahren of Dinsmore & Shohl LLP.

Just in Time for the Holidays: Another HIPAA Settlement

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution Agreement and Corrective Action Plan (CAP) to settle alleged violations of the HIPAA Security Rule, which governs the safeguarding of electronic protected health information (ePHI). OCR initiated an investigation into ACMHS’s compliance with HIPAA after receiving a March 2, 2012 notification from the provider regarding a breach of unsecured ePHI affecting 2,743 individuals. The breach resulted from malware that compromised ACMHS’s information technology resources.

OCR’s investigation found that ACMHS (1) had never performed an accurate and thorough risk assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS; (2) had never implemented Security Rule policies and procedures; and (3) since 2008, had failed to implement technical security measures to guard against unauthorized access to ePHI transmitted electronically, by failing to ensure that appropriate firewalls were in place and regularly updated with available patches.

ACMHS agreed to pay $150,000 and to comply with the requirements set forth in the CAP to settle the allegations. The CAP has a two-year term and obligates ACMHS to take the following actions:

Revise, adopt and distribute to its workforce updated Security Rule policies and procedures that have been approved by OCR
Develop and provide updated security awareness training (based on training materials approved by OCR) to applicable workforce members, and update and repeat the training annually
Conduct annual risk assessments of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS, and document the security measures implemented to reduce the risks and vulnerabilities to a reasonable and appropriate level
Investigate and report to OCR any violations of its Security Rule policies and procedures by workforce members
Submit annual reports to OCR describing ACMHS’s compliance with the CAP

In announcing the settlement, OCR Director Jocelyn Samuels said, “[s]uccessful HIPAA compliance requires a common sense approach to assessing and addressing the risks to ePHI on a regular basis. This includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.” A copy of the Resolution Agreement and CAP can be found here.

The settlement is another reminder that covered entities and business associates should ensure that they have taken steps necessary and appropriate to safeguard the ePHI in their possession. Conducting regular ePHI risk assessments, addressing any identified security vulnerabilities, implementing and updating comprehensive HIPAA policies and procedures, and appropriately training workforce members who have access to ePHI are all steps that covered entities and business associates must take to comply with HIPAA and protect ePHI.

Office for Civil Rights (OCR) to Begin Phase 2 of HIPAA Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security and breach notification standards (HIPAA Standards) as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Unlike the pilot audits during 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR will conduct Phase 2 Audits of both covered entities and business associates. The Phase 2 Audit Program will focus on areas of greater risk to the security of protected health information (PHI) and pervasive noncompliance based on OCR’s Phase I Audit findings and observations, rather than a comprehensive review of all of the HIPAA Standards. The Phase 2 Audits are also intended to identify best practices and uncover risks and vulnerabilities that OCR has not identified through other enforcement activities. OCR will use the Phase 2 Audit findings to identify technical assistance that it should develop for covered entities and business associates. In circumstances where an audit reveals a serious compliance concern, OCR may initiate a compliance review of the audited organization that could lead to civil money penalties.

The following sections summarize OCR’s Phase 1 Audit findings, describe the Phase 2 Audit program and identify steps that covered entities and business associates should take to prepare for the Phase 2 Audits.

Phase 1 Audit Findings

OCR audited 115 covered entities under the Phase 1 Audit program, with the following aggregate results:

There were no findings or observations for only 11% of the covered entities audited;
Despite representing just more than half of the audited entities (53%), health care providers were responsible for 65% of the total findings and observations;
The smallest covered entities were found to struggle with compliance under all three of the HIPAA Standards;
Greater than 60% of the findings or observations were Security Standard violations, and 58 of 59 audited health care provider covered entities had at least one Security Standard finding or observation even though the Security Standards represented only 28% of the total audit items;
Greater than 39% of the findings and observations related to the Privacy Standards were attributed to a lack of awareness of the applicable Privacy Standard requirement; and
Only 10% of the findings and observations were attributable to a lack of compliance with the Breach Notification Standards

The Phase 2 Audit Program

Selection of Phase 2 Audit Recipients

Unlike the Phase 1 Audit Program, which focused on covered entities, OCR will conduct Phase 2 Audits of both covered entities and business associates. OCR has randomly selected a pool of 550–800 covered entities through the National Provider Identifier database and America’s Health Insurance Plans’ databases of health plans and health care clearinghouses. OCR will issue a mandatory pre-audit screening survey to the pool of covered entities this summer. The survey will address organization size measures, location, services and contact information. Based on the responses, the agency will select approximately 350 covered entities, including 232 health care providers, 109 health plans and 9 health care clearinghouses, for Phase 2 Audits. OCR intends to select a wide range of covered entities and will conduct the audits between October 2014 and June 2015.

OCR will notify and send data requests to the 350 selected covered entities this fall. The data requests will ask the covered entities to identify and provide contact information for their business associates. OCR will select the business associates that will participate in the Phase 2 Audits from this pool.

Audit Process

OCR will audit approximately 150 of the 350 selected covered entities and 50 of the selected business associates for compliance with the Security Standards, 100 covered entities for compliance with the Privacy Standards and 100 covered entities for compliance with the Breach Notification Standards. OCR will initiate the Phase 2 Audits of covered entities by sending the data requests this fall and then initiate the Phase 2 Audits of business associates in 2015.

Covered entities and business associates will have two weeks to respond to OCR’s audit request. The data requests will specify the content, file names and other documentation requirements, and the auditors may contact the covered entities and business associates for clarifications or additional documentation. OCR will only consider current documentation that is submitted on time. Failure to respond to a request could lead to a referral to the applicable OCR Regional Office for a compliance review.

Unlike the Phase 1 Audits, OCR will conduct the Phase 2 Audits as desk reviews with an updated audit protocol and not on-site at the audited organization. OCR will make the Phase 2 Audit protocol available on its website so that entities may use it for internal compliance assessments.

The Phase 2 Audits will target HIPAA Standards that were sources of high numbers of non-compliance in the Phase 1 Audits, including: risk analysis and risk management; content and timeliness of breach notifications; notice of privacy practices; individual access; Privacy Standards’ reasonable safeguards requirement; training to policies and procedures; device and media controls; and transmission security. OCR also projects that Phase 2 Audits in 2016 will focus on the Security Standards’ encryption and decryption requirements, facility access control, breach reports and complaints, and other areas identified by earlier Phase 2 Audits. Phase 2 Audits of business associates will focus on risk analysis and risk management and breach reporting to covered entities.

OCR will present the organization with a draft audit report to allow management to comment before it is finalized. OCR will then take into account management’s response and issue a final report.

What Should You Do to Prepare for the Phase 2 Audits?

Covered entities and business associates should take the following steps to ensure that they are prepared for a potential Phase 2 Audit:

Confirm that the organization has recently completed a comprehensive assessment of potential security risks and vulnerabilities to the organization (the Risk Assessment);
Confirm that all action items identified in the Risk Assessment have been completed or are on a reasonable timeline to completion;
Ensure that the organization has a complete inventory of business associates for purposes of the Phase 2 Audit data requests;
If the organization has not implemented any of the Security Standards’ addressable implementation standards for any of its information systems, confirm that the organization has documented (i) why any such addressable implementation standard was not reasonable and appropriate and (ii) all alternative security measures that were implemented;
Ensure that the organization has implemented a breach notification policy that accurately reflects the content and deadline requirements for breach notification under the Breach Notification Standards;
Health care provider and health plan covered entities should ensure that they have a compliant Notice of Privacy Practices and not only a website privacy notice;
Ensure that the organization has reasonable and appropriate safeguards in place for PHI that exists in any form, including paper and verbal PHI;
Confirm that workforce members have received training on the HIPAA Standards that are necessary or appropriate for a workforce member to perform his/her job duties;
Confirm that the organization maintains an inventory of information system assets, including mobile devices (even in a bring your own device environment);
Confirm that all systems and software that transmit electronic PHI employ encryption technology or that the organization has a documented the risk analysis supporting the decision not to employ encryption;
Confirm that the organization has adopted a facility security plan for each physical location that stores or otherwise has access to PHI, in addition to a security policy that requires a physical security plan; and
Review the organization’s HIPAA security policies to identify any actions that have not been completed as required (e.g., physical security plans, disaster recovery plan, emergency access procedures, etc.)

ARTICLE BY

Patrick Callaghan

Daniel F. Gottlieb

Edward G. Zacharias

Of:

McDermott Will & Emery

Tag: OCR

HIPAA Gets a Potential Counterpart in HISAA

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