United States: HIPAA Settlement Emphasizes Importance Of Risk Analysis And Media Control Policies

Last Updated: September 15 2015
Article by Kim Metzger

On September 2, 2015, the U.S. Department of Health & Human Services' Office for Civil Rights (OCR) – which enforces the HIPAA Privacy, Security, and Breach Notification Rules – announced that it reached a Resolution Agreement and Corrective Action Plan (RA/CAP) with the Cancer Care Group, P.C., to settle potential Security Rule violations.  The covered entity will pay $750,000 and institute a "robust" corrective action plan.

Cancer Care Group, P.C., is a 13-member physician practice serving Indiana hospitals and clinics.  In August 2012, the group notified OCR that a laptop containing unsecured protected health information (PHI) for approximately 55,000 patients had been stolen from an employee's car.  The information included names, addresses, dates of birth, Social Security numbers, insurance information, and clinical information.

The OCR's investigation revealed the covered entity had been in "widespread non-compliance" with the Security Rule since before the breach.  The group had not performed an enterprise-wide risk analysis, and did not have a written policy in place to address the "common practice" of removing hardware and electronic media containing PHI from the facility.  According to OCR, a risk analysis could have identified removal of unencrypted backup media as an area of significant risk to the organization, and a written policy could have directed employees as to their responsibilities under these circumstances.   Under the terms of the CAP, Cancer Care will conduct a risk analysis; develop and implement a risk management plan; review and revise policies and procedures; and review and revise its training program. 

The Cancer Care RA/CAP emphasizes the importance of a robust, thorough, entity-wide risk assessment for ePHI.  According to OCR Director Jocelyn Samuels: 

"Organizations must complete a comprehensive risk analysis and establish strong policies and procedures to protect patients' health information .... Further, proper encryption of mobile devices and electronic media reduces the likelihood of a breach of protected health information."

The HIPAA Security Rule requires covered entities and business associates to conduct an "accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information" they hold.  (45 CFR 164.308(a)(1)(ii)(A)).  Small health care providers are not exempt from this requirement.  While entities are not required to outsource their risk assessment, the services of an experienced professional will assist in providing a RA that will withstand an OCR compliance review.  The regulations do not specify a particular form of risk assessment, and there are many approaches to take.  However, the risk assessment must begin with a thorough data map that identifies all locations and flows of ePHI – including portable electronic devices and copiers that store data.  Most importantly, the risk assessment is not a "once and done" process.  The entity must review, correct, modify, and update its RA to account for changes in the law as well as in the entity's environment and ePHI locations and flows.

There is no better time for covered entities and business associates to evaluate their risk assessment and ensure they are in compliance.  As OCR Director Jocelyn Samuels emphasized during her keynote address at a September 2, 2015 HIPAA security conference in Washington, D.C., the upcoming second round of OCR compliance audits will focus on key compliance areas such comprehensive and timely risk assessment.[1]  Director Samuels noted she hopes the audit process will "send a message that complying with HIPAA is serious business."  Id.

The Cancer Care RA/CAP also emphasizes the importance of security for laptops and other portable electronic devices.  The federal government's Office of the National Coordinator for Health Information Technology (ONC) offers health care providers and other organizations suggestions for managing mobile devices used by health care providers and professionals:

  • Decide whether mobile devices will be used to access, receive, transmit, or store ePHI or used as part of the organization's internal networks or systems (for example, the EHR system).
  • Assess how mobile devices affect the risks (threats and vulnerabilities) to the organization's ePHI.
  • Identify the organization's mobile device risk management strategy, including privacy and security safeguards.
  • Develop, document, and implement the organization's mobile device policies and procedures to safeguard PHI.
  • Train providers and professionals on best practices for mobile device privacy and security.

ONC also offers its Top 10 Tips for Cybersecurity in Health Care, which emphasize mobile device security:

  1.      Establish a security culture.

  • Build a security-minded educational culture so good habits and practices become automatic.
  • Conduct information security education frequently, on an ongoing basis.
  • Ensure managers and other leaders set a good example in attitude and action.
  • Make taking responsibility for information security a core organizational value.

2.      Protect mobile devices.

  • Ensure mobile devices are equipped with strong authentication and access controls (ensure laptops have password protection, and enable password protection on mobile devices; take extra physical control precautions if password protection is not provided).
  • Protect wireless transmissions from intrusion.
  • Do not transmit unencrypted protected health information across public networks.
  • Encrypt data when it is necessary to commit health information to a mobile device, or remove a device from a secure area.
  • Do not use mobile devices that cannot support encryption.
  • Install and activate remote wiping and/or remote disabling.
  • Disable and do not install or use file sharing applications.
  • Install and enable security software, and keep it up-to-date.
  • Research mobile applications before downloading.
  • Maintain physical control:  keep it with you or lock it in a secure location; lock the screen when not in use; do not let others use it.

3.      Maintain good computer habits.

  • Configuration management
    • Uninstall unessential software applications.
    • Use caution when accepting default or standard configurations when installing software.
    • Ask whether your EHR developer maintains an open connection to installed software to provide updates and support – if so, ensure a secure connection at the firewall and request that this access be disabled when not in use.
    • Disable remote file sharing and remote printing within the operating system.
  • Software maintenance
    • Automate software updates to occur regularly.
    • Monitor for critical and urgent patches and updates that require immediate attention, and act upon them as soon as possible.
  • Operating system maintenance
    • Disable user accounts for former employees quickly and appropriately.  Close access to the accounts of involuntarily terminated employees before serving notice of termination.
    • Before disposal, sanitize computers and other devices that have had data stored on them.  The National Institute of Standards and Technology (NIST) publishes guidelines for disposal.
    • Archive old data files for storage if needed, or clean them off the system if not needed, subject to applicable data retention requirements.
    • Fully uninstall software that is no longer needed, including trial software and old versions of current software.
    • Work with your IT team or other resources to perform malware, vulnerability, configuration, and other security audits on a regular basis.

4.      Use a firewall.

  • Unless the EHR is completely disconnected from the Internet, install a firewall to protect against outside intrusions and threats.
  • Large practices that use a Local Area Network (LAN) should consider a hardware firewall.

5.      Install and maintain anti-virus software.

  • Use an anti-virus product that provides continuously updated protection against malware, viruses, and other code that attacks computers through web downloads, CDs, email, and flash drives.
  • Keep anti-virus software up-to-date.

6.      Plan for the unexpected.

  • Create regular and reliable data backups.
  • Consider storing backup far from the main system.
  • Protect backup media with access controls.
  • Test backup media regularly for ability to properly restore data.
  • Have a sound recovery plan.  Know what data was backed up, when backups were done, where backups are stored, and what equipment is needed to restore backups.
  • Keep the recovery plan securely and remotely, where an identified person has responsibility to produce it in an emergency.

7.      Control access to health information.

  • Configure electronic records to grant access only to people with a need to know.
  • Set access permissions using an access control list.  Before setting permissions, identify which files should be accessible to which staff members.
  • Configure role-based access as needed.  In role-based access, a staff member's role within the organization (for example:  physician, nurse, billing specialist) determines what information he or she may access.  Assign staff to the correct roles, and set access permissions for each role correctly, on a need-to-know basis.

8.      Use strong passwords and change them regularly.

  • Choose passwords that wrongdoers cannot easily guess.  For example, a strong password may be of a certain length (the longer the better), combining upper- and lower-case letters, and special characters such as punctuation marks.
  • Do not include personal information in passwords, such as birthdates, one's own name or the names of family members or pets, Social Security numbers, or information on social networking sites or other locations that others could easily discover.
  • Require multi-factor authentication, such as passwords plus fingerprint scans or randomly-generated PINs. 
  • Configure systems so that passwords must be regularly changed.
  • Develop a password reset process to provide quick and easy assistance for forgotten passwords.  This will discourage staff from writing down passwords.

9.      Limit network access.

  • Prohibit installation of software without prior approval.
  • Set any wireless router to operate only in encrypted mode.
  • Prohibit casual network access by visitors.
  • Ensure that file sharing, instant messaging, and other peer-to-peer applications have not been installed without explicit review and approval.

10.  Control physical access.

  • Limit the opportunity for devices to be tampered with, lost, or stolen.
  • Document and enforce policies limiting physical access to devices and information.

The Security Rule risk assessment is a cornerstone of compliance and is mandatory for covered entities and business associates of all sizes.  The Cancer Care RA/CAP emphasizes the importance of both risk assessment and portable mobile device security.  Attending to the ONC's guidance, and engaging an experienced professional, can assist covered entities and business associates in meeting their compliance goals.  This, in turn, will safeguard patient data, lessen the likelihood of a breach, and enable the entity to perform well in the event of an OCR compliance audit.


[1] Marianne Kolbasuk McGee, New HIPAA Compliance Audit Details Revealed, http://www.govinfosecurity.com/hipaa-compliance-audits-on-way-a-8518 (accessed September 3, 2015).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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