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.

Footnote

[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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions