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.
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Just in Time for the Holidays: Another HIPAA Settlement

Mcdermott Will Emery Law Firm

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

Mcdermott Will Emery Law Firm

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.)