2016 News Stories

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New NIST Guide for Cybersecurity Event Recovery Released

On December 23, 2016, the National Institute of Standards and Technology (NIST) released a little Christmas gift, a new final Special Publication 800-184 an excellent overall Guide for Cybersecurity Event Recovery that now incorporates incident handling and contingency planning.  The press release (at https://www.nist.gov/news-events/news/2016/12/nist-guide-provides-way-tackle-cybersecurity-incidents-recovery-plan ) provides a good overview, and the Guide is available at:   http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-184.pdf  

From the press release: "The publication supplies tactical and strategic guidance for developing, testing and improving recovery plans, and calls for organizations to create a specific playbook for each possible cybersecurity incident. The guide provides examples of playbooks to handle data breaches and ransomware.”  This approach supports my view that developing and working through drills on various scenarios is one of the best ways to be prepared for a nasty security event.  Bravo!

21st Century Cures Act Includes Health IT and HIPAA Impacts

On December 8, 2016, AHIMA published an informative guide to the Health IT and HIM related sections of the 21st Century Cures Act, now signed by President Obama.  There are numerous sections pertinent to those in HIPAA compliance, and this overview guide from AHIMA is easy to use and understand.  

In fact, many of the things called for relating to HIPAA, such as guidance on sharing information with family, friends, and others involved with an individual’s care, are already in the works at HHS Office for Civil Rights, but the legislation provides a solid foundation for these activities.

This legislation has non-trivial, wide ranging impacts on HIPAA.  See the AHIMA guide at:  http://bok.ahima.org/doc?oid=302012  

NIST Issues Guide to Securing Mac OS X for Security Pros

On December 12, 2016 NIST announced the Release of Special Publication 800-179, Guide to Securing Apple OS X 10.10 Systems for IT Professionals: A NIST Security Configuration Checklist. This Special Publication has been approved as final, and is available at:  http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-179.pdf  

SP 800-179 aims to assist IT professionals in securing Apple OS X 10.10 desktop and laptop systems within various environments providing detailed information about the security features of OS X 10.10 and security configuration guidelines. The publication recommends and explains tested, secure settings with the objective of simplifying the administrative burden of improving the security of OS X 10.10 systems in three types of environments: Standalone, Managed, and Specialized Security-Limited Functionality. 

Additional project resources are at: https://github.com/usnistgov/applesec

Phony OCR E-mails are Phishing Attacks; Avoid hhs-gov.us

On November 28 and 30, HHS Office for Civil Rights announced that a phishing e-mail is being circulated on mock HHS Departmental letterhead.  The e-mail appears to be an official government communication, and targets employees of HIPAA covered entities and their business associates, prompting recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program.  The link directs individuals to a non-governmental website marketing a firm’s cybersecurity services.

In no way is this firm associated with the U.S. Department of Health and Human Services or the Office for Civil Rights.  The links in the e-mail lead to addresses in the domain “hhs-gov.us” which is not an official HHS domain.  HHS addresses end in “hhs.gov”.  For more information on the HIPAA Audit program and this announcement, see:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html  

Oh, and By The Way, Business Associate Audits Have Begun

Almost as a footnote in the November 30 announcement above, HHS Office for Ciliv Rights has announced that the first notices for audits have been sent to the Business Associates being targeted for the current round of audits.  If you are a HIPAA Business Associate and any of your customers were selected in the covered entity audits this year, you could be selected for an audit.  Be sure to watch your e-mail and spam filters for the message from HHS!

Where the Network Goes, HIPAA goes; $650K for No Firewall

On November 22, 2016, HHS Office for Civil Rights announced a $650,000 settlement for potential HIPAA violations at UMass Amherst, for not protecting networks with a firewall, leading to a breach of PHI.  In addition, UMass Amherst had not properly designated itself as a Hybrid entity, leaving some HIPAA-covered portions without the appropriate safeguards.  It should be noted that the penalty was lower than might be expected for the violation, because of the net operating loss for the University at the time.  See the press release and agreement at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/umass  

NIST Updates Small Business Information Security Guide

On November 14, 2016, The National Institute of Standards and Technology (NIST) released Interagency Report NISTIR 7621 Revision 1, Small Business Information Security: The Fundamentals. NIST developed this interagency report as a reference guideline about cybersecurity for small businesses. This document is intended to present the fundamentals of a small business information security program in non-technical language.  It is a great overview of what goes into an information security program.  See: http://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.7621r1.pdf

Secure That Server Properly On Installation, OR ELSE!

On October 18, 2016, the HHS Office for Civil Rights announced that St. Joseph Health (SJH) has agreed to settle potential violations of the HIPAA Privacy and Security Rules following the report that files containing PHI were publicly accessible through internet search engines from 2011 until 2012.  A default file sharing application had been left open on installation of a server.  Risk Analyses had been performed but were patchwork and incomplete.  SJH will pay a settlement amount of $2,140,500 and adopt a comprehensive corrective action plan.  See the press release and agreement at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/sjh  

Yet another reminder that launching a server is like preparing for takeoff — you have to go through a complete checklist, like applicable sections of the CIS Controls for Effective Cyber Defense (https://www.cisecurity.org/critical-controls/), when launching a new server.  And make sure your Risk Analysis is complete!

Surprise! Ready for ACA Section 1557? New FAQs Available

On September 14, 2016, the HHS Office for Civil Rights announced New Section 1557 FAQs on Language Access Requirements and the Top 15 Languages and many providers weren’t even aware of the rule or the October 17, 2016 deadline for compliance.  Beginning on October 17, 2016, covered entities will be required to post Notices of Nondiscrimination and Taglines that alert individuals with limited English proficiency (LEP) to the availability of language assistance services.  Read the FAQs on the Language Access Requirements here:  http://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/top15-languages/index.html

In addition, HHS OCR has made available a table displaying the top 15 languages spoken by individuals with limited English proficiency (LEP) in each State, the District of Columbia, Puerto Rico and each U.S. Territory based on OCR’s research.  View the table of the top 15 languages in each state:  http://www.hhs.gov/sites/default/files/resources-for-covered-entities-top-15-languages-list.pdf  

HHS 2013-2014 Report to Congress on Breach Notification

On August 30, 2016, the Secretary of HHS reported to Congress on the status of the HIPAA Breach Notification program, for the 2013-2014 period, as required under the HITECH Act, section 13402.  The report shows the percentages of breaches by theft and loss are decreasing while unauthorized access and “other” are up, by a number of measures.  

This means the hackers are doing a lot more damage while we still have a significant problem with loose data.  There’s also a good summary of enforcement and audit activity in the 2013-2014 period.  Especially take note of the section on Lessons Learned to see what you can do to avoid breaches, on pages 28-30.  The report is available at:  http://www.hhs.gov/sites/default/files/rtc-breach-20132014.pdf  

HHS Releases Long-Awaited Guidance on Cloud Computing

On October 7, 2016, the US Department of Health and Human Services Office for Civil Rights released guidance on using cloud-based solutions to help HIPAA-regulated CSPs (Cloud Service Providers — hello new acronym!) and their customers in understanding their responsibilities under the HIPAA Rules when they create, receive, maintain, or transmit electronic protected health information.  The guidance includes key questions and answers.  See:  http://www.hhs.gov/hipaa/for-professionals/special-topics/cloud-computing/index.html  Frequently Asked Questions about Business Associates are available at  http://www.hhs.gov/hipaa/for-professionals/faq/business-associates   

This is an area that has been begging for guidance ever since the new rules come out in 2013, as the rules and Preamble did not adequately consider such computing solutions.   Note that the guidance includes several references to the guidance in the story below, on availability of PHI.  With these guidance documents and the guidance on Individual Access of PHI, it is clear that HHS is quite serious about the availability of PHI.

HHS Releases New FAQ on Availability of PHI Maintained by BA

On September 28, 2016, the US Department of Health and Human Services Office for Civil Rights released a new set of Frequently Asked Questions about how Business Associates must maintain availability of PHI.  The FAQs address "whether a business associate of a HIPAA covered entity may block or terminate access by the covered entity to the protected health information maintained by the business associate”.  The short answer is, No.  Data may not be held hostage for non-payment of fees, for instance.  PHI must be returned upon termination of an agreement.  Also, if the covered entity signs an agreement that prevents it from ensuring the availability of its PHI, it is not in compliance.  Check your contracts!  See:  http://www.hhs.gov/hipaa/for-professionals/faq/2074/may-a-business-associate-of-a-hipaa-covered-entity-block-or-terminate-access/index.html

$400K Settlement for Breaches and Not Having BA Agreements

On September 23, 2016, the US Department of Health and Human Services Office for Civil Rights announced a settlement with Care New England Health System (CNE), on behalf of each of the covered entities under its common ownership or control, for the loss of a backup tape with information on 14,000 individuals, without an up-to-date Business Associate Agreement in place for handling the tapes.  Even if you are in the same corporate family, if you have a BA relationship, you need a compliant BAA.  If HHS asks and you don’t have one, you will be in trouble.  Easy as that!  For the press release and settlement agreement, please see:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/wih  

NIST Releases SP 800-177 on Trustworthy E-mail

On September 16, 2016, NIST released Special Publication 800-177, Trustworthy Email, which overs and gives recommendations for state of the art email security technologies to detect and prevent phishing and other malicious email messages. Most of these new technologies rely on publishing email infrastructure-related information in DNSSEC, a secure version of the established Domain Name System (DNS). The guide was written for email administrators and for those developing security policies for enterprise’s email infrastructure.  See:  http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-177.pdf  

FTC Advises: Watch that Rental Car USB Port!

The Federal Trade Commission has advised people to be wary of using their smart phones with the USB ports in rental cars.  Cars can pull information out of your phone without your knowing it and can retain your contacts, etc. for the next renter.  Be sure to clear out your rental car’s memory when you turn it in!  See:  https://www.consumer.ftc.gov/blog/what-your-phone-telling-your-rental-car  and  https://fcw.com/articles/2016/08/31/ftc-cert-rockwell.aspx  Always be careful using any USB ports you don’t control, in cars or at airports!

HHS Releases Updated HIPAA Security Risk Assessment Tool

In early September 2016, HHS Office of the National Coordinator for Health IT released an updated version of the HIPAA Security Risk Assessment Tool for Windows and iPad with new compatibility with Windows 10, and additional functionality for the iPad version.  For more information, see:  https://www.healthit.gov/providers-professionals/security-risk-assessment-tool  

HIMSS Releases 2016 Cybersecurity Survey Report

HIMSS has released its report on its 2016 Cybersecurity Survey which gathers information from a number of entities to develop a picture of the issues facing healthcare entities regarding cybersecurity, and some of the measures entities take to deal with the issues.  Available at: http://www.himss.org/hitsecurity

HHS OCR Will Make More Investigations into Small Breaches

On August 18, 2016, the US Department of Health and Human Services Office for Civil Rights announced an “Initiative to More Widely Investigate Breaches Affecting Fewer than 500 Individuals”.  HHS regional offices will take on the load, and look into factors such as: 
• The size of the breach
• Theft of or improper disposal of unencrypted PHI
• Breaches that involve unwanted intrusions to IT systems (for example, by hacking)
• The amount, nature and sensitivity of the PHI involved
• Instances where numerous breach reports from a particular covered entity or business associate raise similar issues.  

OCR noted that regions may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.  In other words, if everyone else like you reports breaches and you don’t, why not?

The press release will be available at:  http://www.hhs.gov/ocr/newsroom/index.html#  

Advocate Health Care Ignores Security Rule = $5.5 million

The flood of HIPAA settlements continues.  On August 4, 2016, the US Department of Health and Human Services Office for Civil Rights announced a $2.75 million resolution agreement with Advocate Health Care for potential violations of the HIPAA Security Rule leading in some cases leading to breaches, affecting four million people.  No complete RA, no physical controls at a data center, no BAA with a vendor holding PHI, and an unencrypted laptop stolen from an unlocked car overnight.  Let us count the violations!  Yes, it is a record settlement amount.  See:  http://www.hhs.gov/about/news/2016/08/04/advocate-health-care-settles-potential-hipaa-penalties-555-million.html  

Annual NIST/OCR HIPAA Security Conference Announced

The NIST Information Technology Laboratory announced the next NIST/OCR HIPAA Security conference — Safeguarding Health Information: Building Assurance through HIPAA Security - 2016 — in Washington, DC, set for Wednesday and Thursday, October 19-20, 2016, at the Capital Hilton, and available by Webcast as well.  This is the ONLY conference that I ALWAYS attend every year — you get access to the best experts in a non-commercial setting, and insights you can gain nowhere else.  If you can, go, or at least attend the Webcast.  See:  http://www.nist.gov/itl/csd/safeguarding-health-information-hipaa-security-2016.cfm  

DHS Releases Cyber Incident Reporting Guide

On July 28, 2016, the US Department of Homeland Security released Cyber Incident Reporting:  A Unified Message for Reporting to the Federal Government, providing guidance on to which Federal agencies and departments certain Cyber Incidents should be reported.  Best to pay attention to this, if you suffer some kind of Cyber Incident!  The DHS page hosting the guidance is at:  https://www.dhs.gov/publication/cyber-incident-reporting-unified-message-reporting-federal-government  and the guidance document is available at:  https://www.dhs.gov/sites/default/files/publications/Cyber%20Incident%20Reporting%20United%20Message.pdf  

HHS Issues New Guidance on HIPAA Audits and on Device IDs

On July 27, 2016, the HHS Office for Civil Rights provided new HIPAA Audit Guidance & FAQ on HIPAA and Unique Device Identifiers.

1) Guidance for 2016 HIPAA Desk Audits 

Covered entities received notification of their selection as the subjects of an Office for Civil Rights (OCR) desk audit of compliance with the HIPAA Security, Privacy and Breach Notification Rules on July 11, and were invited to participate in a webinar held on Wednesday, July 13, where OCR staff walked through the processes for the audit and expectations for their participation.  

To respond to questions, OCR developed three targeted guidance documents, available at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html.  

 — One is a comprehensive question and answer listing.  

 — The second puts the specific audit document submission requests in context with the rule requirements and associated protocol audit inquiries, as well as the related questions asked by selected entities.  The entire protocols are available on the OCR website; for this guidance we extracted from those protocols the specific desk audit provisions, and added the audit inquiries and Q&A.  

 — Finally, OCR has posted the slides used in the webinar.  The guidance should be helpful to audited entities as well as other covered entities and business associates seeking assistance with improving their compliance with these important requirements of the HIPAA Rules.  

2) New FAQ: HIPAA and Unique Device Identifiers (Note: "Device Identifiers" is NOT a unique identifier — which one are you taking about?  Are you lost yet?  No?  Read on...)

OCR has posted a new FAQ on HIPAA and Unique Device Identifiers (UDI), which clarifies that the device identifier (DI) portion of a UDI can be part of a limited or de-identified data set as defined under HIPAA.  While the HIPAA Privacy Rule prohibits the inclusion of “device identifiers and serial numbers” in both limited data sets and data sets that are de-identified in accordance with the “de-identification safe harbor” provisions, the guidance explains that the DI portion of the UDI is not the type of “device identifier” to which these HIPAA Privacy Rule provisions refer.  (Oh Boy!  “Device Identifiers” that aren’t “Device Identifiers”!  Aren’t the regulations simple and unambiguous?  No, you say?)

You may find the new FAQ on OCR’s website at:  http://www.hhs.gov/hipaa/for-professionals/faq/2071/can-device-identifier-di-portion-unique-device-identifier-udi-be-part-limited-or-de-identified

Ignoring Security Costs U Miss Med Center $2.75 million

On July 25, 2016, the US Department of Health and Human Services Office for Civil Rights announced a $2.75 million resolution agreement with University of Mississippi Medical Center for lack of attention to security, even after vulnerabilities and risks were noted.  The agreement announcement, available at:  http://www.hhs.gov/about/news/2016/07/21/ocr-announces-275-million-settlement-multiple-alleged-hipaa-violations.html  cited a number of issues resulting in breaches and exposure of patient information.  Compliance would have been WAY cheaper than the agreement, shall we say. 

Joint Commission Says “Whoa!” to Removal of Texting Ban

On July 18, 2016, Health IT Security reported that the Joint Commission on Accreditation of Healthcare (JCAHO) has decided to delay the removal of a ban on the use of texting (even secure texting) for physician ordering that had been previously announced.  Instead, they will wait for guidance to be developed by JCAHO and CMS to ensure texting is done correctly and aligns with the Medicare Conditions of Participation.  

The ban had been put in place because “texting applications were unable to verify the identity of the person sending the text or to retain the original message as validation of the information entered into the medical record,” the Commission stated. - See more at: http://healthitsecurity.com/news/secure-texting-ban-reinstated-commission-calls-for-guidance

Insufficient Risk Analysis and Risk Management Cost $2.7m

On July 18, 2016, (cue Sonny and Cher music, The Beat Goes On) the US Department of Health and Human Services Office for Civil Rights announced a $2.7 million resolution agreement with Oregon Health and Science University for a variety of issues, including insufficient risk analysis and risk management, lack of encryption, lack of a Business Associate Agreement with a cloud vendor hosting PHI, and breaches causing harm to individuals.  

I’ve always maintained that academic medical centers are the most difficult institutions to being into HIPAA compliance, and this is a perfect illustration.  

• The press release is available at:  http://www.hhs.gov/about/news/2016/07/18/widespread-hipaa-vulnerabilities-result-in-settlement-with-oregon-health-science-university.html   
• The resolution agreement and corrective action plan are available at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/ohsu/index.html  

FBI Issues Security Guidance for Healthcare Information

On July 13, 2016, Health Data Management reported that the FBI has issued guidance on best practices for protecting healthcare data, re-emphasizing some well-known precautions, but also including others that may not be widely used.  It is an excellent list to start with for your security improvement program that is essential today.  See: http://www.healthdatamanagement.com/news/fbi-sees-rising-cyber-threats-to-healthcare-organizations

HIPAA Audits for 167 Covered Entities Now Under Way

On July 11, 2016, the US Department of Health and Human Services Office for Civil Rights issued notices to the 167 HIPAA Covered Entities being audited in the round of 2016 desk audits.  If you are a CE and you have NOT been notified, you are not likely to be notified for a desk audit.  Some entities received a request for information on Privacy (in the areas of Notice of Privacy Practices and Access of PHI), and some received a request for information related to Risk Analysis and Risk Management under the Security Rule.  All received a request for a list of Business Associates and contact information.  

Information must be provided by July 22, 2016, and the process is expected to take roughly 90 days to complete for each entity (including time to respond to initial findings), with the program expected to completed by the end of December, 2016.

A selection of Business Associates will receive a desk audit in the fall, and there will still be some on-site audits for some Covered Entities yet to go.  Information on the HIPAA Audit Program is available at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html  

HHS OCR Issues Fact Sheet on Dealing with Ransomware

On July 11, 2016, the HHS Office for Civil Rights released Fact Sheet: Ransomware and HIPAA, providing guidance to health care entities about what ransomware is and how good HIPAA compliance helps you deal with it, and indicates that a ransomware attack should be considered a breach, because control of the PHI has been compromised.  The fact sheet is available at:  http://www.hhs.gov/sites/default/files/RansomwareFactSheet.pdf  

HIPAA Business Associate Gets $650K Settlement for Breach

On June 30, 2016, the US Department of Health and Human Services announced a $650,000 settlement agreement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) for potential violations of the HIPAA Security Rule after the theft of an unprotected CHCS iPhone compromised the PHI of hundreds of nursing home residents.  

The iPhone was unencrypted and was not password protected.  The information on the iPhone was extensive, and included social security numbers, information regarding diagnosis and treatment, medical procedures, names of family members and legal guardians, and medication information.  At the time of the incident, CHCS had no policies addressing the removal of mobile devices containing PHI from its facility or what to do in the event of a security incident; OCR also determined that CHCS had no risk analysis or risk management plan.  In determining the resolution amount, OCR considered that CHCS provides unique and much-needed services in the Philadelphia region. 

Information on the settlement agreement is available at  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/catholic-health-care-services/index.html  

HHS Issues Ransomware Guidance for Healthcare Entities

In June, 2016, HHS issued new guidance on the protection of healthcare organizations from Ransomware attacks.  The guidance explains what Ransomware is, how to protect your networks from it, and how to respond to it.

An article on the guidance is available in Becker’s Hospital Review, at  http://www.beckershospitalreview.com/healthcare-information-technology/hhs-issues-ransomware-guidance-to-healthcare-organizations.html  and the guidance is available at  http://www.aha.org/content/16/160620cybersecransomware.pdf  

Illinois Adds Health Information to Data Breach Notification

In May 2016, Illinois enacted a law expanding the Illinois Data Breach Notification law to include health insurance and medical information, beginning in 2017.  Note that the law is not limited to HIPAA-covered information; it also includes apps and Web sites that may be outside of HIPAA control.  Flexible notification is also included in the new law, providing more options in notification.

Perhaps most significantly, the law also includes requirements to “implement and maintain reasonable security measures,” including the addition of data security provisions to contracts that disclose personal information to another entity.  It’s time to review the SANS Top 20 Critical Security Controls, as that is becoming the accepted baseline for information security.

The news story in Health IT Security is available at:  http://healthitsecurity.com/news/il-data-breach-notification-law-to-include-healthcare-data  and the Top 20 Critical Security Controls are available at:  https://www.sans.org/critical-security-controls  

Watch That Public USB Outlet!  It could attack your device

In an article published June 1, 2016, the Sydney (Australia) Morning Herald reported that Kaspersky Lab warns that public USB outlets could transmit malicious code and be used for nefarious purposes.  After all, come to think of it, you wouldn’t let someone plug in their USB device to your network because of the risks; why would it be any safer to use a public USB charger?

See the article at:  http://www.smh.com.au/technology/consumer-security/public-usbs-are-not-power-points-kaspersky-warns-of-phone-hacking-danger-20160531-gp8myy.html  

One solution: Using a cable or adapter that blocks data transfer and ONLY can be used for charging.  Much lighter and more portable than a power cube!  See:  http://www.portablepowersupplies.co.uk/portapow-data-block-charge-usb-c-cable/  

HHS OCR Adds Guidance re Fees for Electronic Records Access

On May 24, 2016, the US Department of Health and Human Services Office for Civil Rights issued an update to their guidance on Access of PHI by Individuals, further explaining the use of a $6.50 flat fee for electronic copies of records, and when that fee may or may not be appropriate.  The update is integrated into the Q&A section of the guidance, and is available within the guidance directly at:  http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html#maximumflatfee  while the guidance remains available at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html  

Steps for Prevention of Ransomware Attacks — Do these now!

On May 16, 2016, Health Data Management magazine’s Web site published a very useful, practical guide to preventing ransomware attacks by such means as:
  • Developing a plan for an end-user awareness program and implementing it across the hospital
  • Reviewing the server backup processes and evaluating users' network drive permissions
  • Auditing user privilege roles
  • Disabling macro scripts from MS Office files
  • Reviewing monthly patch management processes and inbound spam and malware protection
  • Installing a next-generation firewall and advanced endpoint protection

Go to the site, copy the entire list, and get to work, right now.  See:  http://www.healthdatamanagement.com/opinion/how-healthcare-providers-can-prevent-ransomware-attacks  

OCR Issues Cyber-Awareness Update on Business Associates

On May 3, 2016, the US Department of Health and Human Services Office for Civil Rights issued a Cyber-Awareness Monthly Update regarding the topic, Is Your Business Associate Prepared for a Security Incident?  The guidance indicates that entities should consider:
• Ensuring that agreements define appropriate uses and disclosures and include requirements to report any other use or disclosure including breaches
• Including in agreements the timeframe for reporting any incidents
• Identifying what must be included in any breach or incident reports
• Ensuring all workforce members are trained and Business Associate privacy and security practices are adequate

Additional details are provided.  The update is available via subscription from HHS OCR (see https://list.nih.gov/cgi-bin/wa.exe?SUBED1=OCR-SECURITY-LIST&a=1) and the current update is available at a number of locations, including:  http://www.inspn.org/wp-content/uploads/2016/05/OCR-CyberAwareness-Monthly-Update.pdf  

Joint Commission Says Secure Texting OK for Orders, but…

On April 29, 2016, the Joint Commission released an update on its position on the use of texting for orders, in its May 2016 issue of Joint Commission Perspectives.  The update indicates the use of secure texting services for management of orders is acceptable practice, with some caveats.  The required components of an order must be included, and the messaging platform should include
• a secure sign-on process, 
• encrypted messaging, 
• delivery and read receipts, 
• date and time stamp, 
• customized message retention time frames, and 
• a specified contact list for individuals authorized to receive and record orders

Communications must be documented, and organizations should:
• Develop an attestation documenting the capabilities of their secure text messaging platform
• Define when text orders are or are not appropriate
• Monitor how frequently texting is used for orders
• Assess compliance with texting policies and procedures 
• Develop a risk management strategy and perform a risk assessment
• Conduct training for staff, licensed independent practitioners, and other practitioners on applicable policies and procedures

The update is available from the Joint Commission at:  http://www.jointcommission.org/assets/1/6/Update_Texting_Orders.pdf  and an article on the topic in mhealthintelligence.com is available at:  http://mhealthintelligence.com/news/joint-commission-ends-text-messaging-ban-for-clinicians#.VyomPGWRgfA.gmail  

Verizon 2016 Data Breach Investigations Report Released

Verizon Enterprise Solutions has released to insiders the ninth Data Breach Investigations Report, pulling together incident data from around the world to reveal insights based on over 100,000 incidents from 82 countries, including analysis of 2,260 confirmed data breaches.  Highlights include:
• 89% of breaches had a financial or espionage motive.
• Over 85% of all of security incidents fit into just nine categories.
• The biggest risks you face and what attacks look like.
• Practical steps you can take today to better protect your data.

Healthcare was listed as a top industry for issues in the categories of Insider and Privilege Misuse, Miscellaneous Errors, Physical Theft and Loss, and Everything Else.  As to the issue of Physical Theft and Loss, they offer the following haiku:

Employees lose things
Bad guys also steal your stuff 
Full disk encryption

This is one of the most useful, practical, readable guides to dealing with current security and data breach issues and should be required reading in every IT department.  See:  http://www.verizonenterprise.com/verizon-insights-lab/dbir/2016/insiders/  

NY Presbyterian Gets $2.2 million Settlement for Allowing TV Crews to Film in the ED

The beat goes on!  On April 21, 2016, the US Department of Health and Human Services Office for Civil Rights announced that reached a $2.2 million settlement with New York Presbyterian Hospital (NYP) for the egregious disclosure of two patients’ PHI to film crews and staff during the filming of “NY Med,” an ABC television series, without first obtaining authorization from the patients. In particular, OCR found that NYP allowed the ABC crew to film someone who was dying and another person in significant distress, even after a medical professional urged the crew to stop

OCR also found that NYP failed to safeguard protected health information and allowed ABC film crews virtually unfettered access to its health care facility, effectively creating an environment where PHI could not be protected from impermissible disclosure to the ABC film crew and staff.

What were they thinking? How could this possibly be seen as OK?  Does anyone work in Compliance?  Academic medical centers tend to be out of control because of their complexity in responsibility and governance but this takes the cake. 

The announcement and agreement, and a link to a FAQ page on Media Access to PHI are available at  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/new-york-presbyterian-hospital/index.html  

FTC/OCR/ONC/FDA Release Developer Tool for Apps and Regs

On April 15, 2016, The Federal Trade Commission (FTC) announced a new web-based tool to help developers of health-related mobile apps understand what federal laws and regulations might apply to them, developed the tool in conjunction with OCR, the HHS Office of National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA).

Based on the developer’s answers to a series of questions about the app, the guidance tool will point the developer toward information about federal laws that might apply, including the FTC Act, the FTC’s Health Breach Notification Rule, HIPAA, and the Federal Food, Drug and Cosmetics Act (FD&C Act).

Developers seeking more information about how the HIPAA Rules might apply to their apps should visit OCR’s health app developer portal.  One new resource on the portal is Health App Use Scenarios and HIPAA, which analyzes whether HIPAA applies to a range of example health app scenarios and offers questions to consider in determining when HIPAA’s regulations cover a particular health app. 

See: http://www.hhs.gov/hipaa/for-professionals/special-topics/developer-portal/index.html

$750K Settlement for Lack of a Business Associate Agreement

On April 20, 2016, the US Department of Health and Human Services Office for Civil Rights announced that Raleigh Orthopaedic Clinic, P.A. of North Carolina (Raleigh Orthopaedic) has agreed to pay $750,000 for potential Privacy Rule violations by handing over protected health information (PHI) for approximately 17,300 patients to a potential business partner without first executing a business associate agreement, leaving this sensitive health information without safeguards and vulnerable to misuse or improper disclosure.  OCR initiated its investigation of Raleigh Orthopaedic following receipt of a breach report on April 30, 2013.  

In addition to the $750,000 payment, Raleigh Orthopaedic is required to revise its policies and procedures for managing business associate relationships, in an extensive Corrective Action Plan.

See the Bulletin and Resolution Agreement at  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/raleigh-orthopaedic-clinic/index.html  

HHS Releases New HIPAA Audit Protocol, Virtually Unusable!

On April 1, 2016, and I hope it wasn’t an April Fool’s joke, the US Department of Health and Human Services Office for Civil Rights updated their HIPAA Audit Protocol for the new HIPAA Audit Program, much to my, and others’ no doubt, frustration.  The old format allowed you to easily copy and paste the protocol into a spreadsheet so you could actually USE it, but no such luck with the new one, because the formatting on the Web site makes it virtually unusable, and impossible to easily paste into Excel in a usable way.  

THANKS HHS!  What a miserable job.  What an embarrassment.  They didn’t even announce the new page, and, by the way guys, if it’s not ready, DON’T POST IT.  You can’t even download an Excel copy.  If you look at the site and try to use it, you’ll see what I mean.  It looks like it might be a great tool for preparing for audits but NOT IN ITS CURRENT UNUSABLE FORMAT.  If you’d like to be as frustrated as I am about this, see http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol-current/index.html  If you’d like to submit comments (and you can imagine the one I submitted) send an e-mail to OSOCRAudit@hhs.gov .  PLEASE FIX THIS, HHS!  No joke!  (Yes, Jim, but what do you REALLY think?)

NIST Releases 2nd Draft of SP 800-177, on Trustworthy Email

On March 30, 2016, the National Institute of Standards and Technology released the second draft of the new Special Publication 800-177, focusing on how plain old insecure e-mail can be remade into Trustworthy E-mail.  This is an incredibly useful document for anyone slightly technically oriented, as it does cover a lot of technical topics but is very approachable, with several very real, very actionable security recommendations.  In this day and age, we ALL need to understand how encrypted email can work, and this SP does a great job of explaining the various protocols and processes behind bringing e-mail into the 21st century.

This is HIGHLY RECOMMENDED READING for anyone wrestling with securing e-mail.  Available at: http://csrc.nist.gov/publications/PubsDrafts.html#800-177  Comments on the new draft may be submitted until April 29, 2016 via e-mail to SP800-177@nist.gov .

2016 HIPAA Audit Program Announced, Saying Not Much New

On March 21, 2016, The US Department of Health and Human Services Office for Civil Rights announced the launch of its 2016 HIPAA Audit Program, providing almost no information that was not already widely believed to be the case.  It hasn’t yet begun, the HIPAA Audit Protocol is not yet updated, and the start of any audits is still a “few months” away.  Yes, Business Associates will be targeted as well as Covered Entities, in “round two,” following the audits of Covered Entities.  Yes, the audits will be, for the most part, desk audits limited to selected areas of the rules, completed within 30 days, but there may be field audits as well.

Perhaps the most useful information is that contact will be made via e-mail from HHS OCR, so make sure your spam filter doesn’t toss them!  If you don’t reply to the e-mail, you may still be selected anyway.  And, the entire process will be completed by December 31, 2016.

The non-announcement is available at  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/phase2announcement/index.html  and the HHS OCR page on the topic (with lots of actually useful Q&A) is available at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html  

Two More Laptop-Related Settlements, re a BA, and Research

On March 16 and 17, 2016, The US Department of Health and Human Services Office for Civil Rights announced new resolution agreements related to the loss or theft of laptop computers, one in the hands of a HIPAA Business Associate and one managed by a research organization.  

North Memorial Health Care of Minnesota did not have an appropriate Business Associate agreement with a major contractor, and had not adequately performed a risk analysis prior to the BA's loss of a laptop full of patient information — $1.55 million settlement and corrective action plan.  See:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/north-memorial-health-care/index.html  

Feinstein Institute for Medical Research did not implement appropriate security precautions or perform a complete risk analysis for HIPAA compliance and lost a laptop via theft from an employee — $3.9 million settlement and a corrective action plan.  See:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/Feinstein/index.html  

In case you missed the memo, it’s a really good idea to encrypt all portable devices containing any PHI!

CIRCL Releases Guidance on Ransomware Defense & Response

On February 23, 2016 the Computer Incident Response Center Luxembourg (CIRCL) released TR-41 Crypto Ransomware - Proactive defenses and incident response, a guide to defending and recovering from Crypto Ransomware attacks.  The guidance provides actionable measures to prevent and repel ransomware incidents.  Highly recommended reading for all!  See:  https://www.circl.lu/pub/tr-41/  

HHS OCR Updates Access Guidance with New Q&As regarding Fees for Providing Copies of PHI

On February 25, 2016, The US Department of Health and Human Services Office for Civil Rights updated its guidance on rights of individuals to access their PHI with an additional set of questions and answers, dealing with fees charged for providing access.  The announcement is available at: http://www.hhs.gov/blog/2016/02/25/new-hipaa-guidance-accessing-health-information-fees-copies.html  and the guidance is available at  http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html#newlyreleasedfaqs

HHS OCR Releases Crosswalk for HIPAA Security vs. NIST Cybersecurity Framework

On February 24, 2016, The US Department of Health and Human Services Office for Civil Rights released a crosswalk between the HIPAA Security Rule and the NIST Cybersecurity Framework to show how the HIPAA Security Rule compares with the NIST Cybersecurity Framework and other security regulations.  For organizations needing to meet multiple security requirements, the crosswalk simplifies compliance by showing where there are overlaps in requirements.  See the announcement, with a link to the crosswalk at:  http://www.hhs.gov/hipaa/for-professionals/security/nist-security-hipaa-crosswalk/index.html  

$25K Settlement for Posting Pictures Without Authorizations

On February 16, 2016, The US Department of Health and Human Services Office for Civil Rights announced a resolution agreement for $25,000 with Complete P.T., Pool & Land Physical Therapy, Inc., operating in the Los Angeles area, for posting patient photographs and testimonials without obtaining a valid HIPAA Authorization on its website, and for not having appropriate policies and procedures for handling the authorization process.  See the announcement and resolution agreement at:  http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/complete-pt/index.html  

HHS OCR Announces Guidance for Health App Developers

In February, 2016, the US Department of Health and Human Services Office for Civil Rights announced new guidance on the application of HIPAA rules to App Developers, and describes the typical circumstances when one may or may not be considered a HIPAA Business Associate.  The guidance is available at:  http://hipaaqsportal.hhs.gov/community-library/accounts/92/925889/OCR-health-app-developer-scenarios-2-2016.pdf  

HHS Announces Proposed Rules to Modify 42 CFR Part 2 Restrictions

On February 5, 2016, the US Department of Health and Human Services announced new proposed regulations for Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2. The goal of the proposed changes is to facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder.  The press release is available at:  http://www.hhs.gov/about/news/2016/02/05/hhs-proposes-changes-to-rules-governing-confidentiality-substance-use-disorder-records.html  
The Proposed rules published in the Federal Register February 9, 2016 are at:  https://www.federalregister.gov/articles/2016/02/09/2016-01841/confidentiality-of-substance-use-disorder-patient-records  
The comment period is open until April 11, 2016.

New HHS Fact Sheets on Exchange of PHI for Treatment and Operations

On February 4, 2016, the US Department of Health and Human Services announced, via its blog, that it had released two fact sheets concerning Permitted Uses and Disclosures for the Exchange of Protected Health Information for purposes of Treatment and for purposes of Health Care Operations, in order to clarify HIPAA regulations and help enable permissible uses and disclosures under the rules.  
• The blog entry is at  https://www.healthit.gov/buzz-blog/electronic-health-and-medical-records/interoperability-electronic-health-and-medical-records/the-real-hipaa-supports-interoperability/  
• The fact sheet on Exchange for Treatment is at  https://www.healthit.gov/sites/default/files/exchange_treatment.pdf  
• The fact sheet on Exchange for Health Care Operations is at  https://www.healthit.gov/sites/default/files/exchange_health_care_ops.pdf  

According to the blog post, this is the first in a series of postings of new guidance meant to clear confusion about HIPAA and promote proper compliance.  "Blog #2 will be background on HIPAA’s Permitted Uses and Disclosures: what they are, and how they advance the national goal of interoperability. Blog #3 will give examples of exchange of health information for Care Coordination, Care Planning, and Case Management, both between providers, and between provider and payers. Finally, Blog #4 will give examples of interoperable, permissible exchange of PHI for Quality Assurance and Population-Based Activities, including via a health information exchange.” 

HHS OCR Announces Fine for Insecure Handling of Paper PHI

On February 3, 2016, The US Department of Health and Human Services Office for Civil Rights announced that an HHS Administrative Law Judge (ALJ) has ruled that Lincare, Inc. (Lincare) violated the HIPAA Privacy Rule and granted summary judgment to OCR on all issues, requiring Lincare to pay $239,800 in civil money penalties.  This is only the second time in its history that OCR has sought CMPs for HIPAA violations, and each time the CMPs have been upheld by the ALJ. 

From the press release: "OCR’s investigation of Lincare began after an individual complained that a Lincare employee left behind documents containing the protected health information (PHI) of 278 patients after moving residences.  Evidence established that this employee removed patients’ information from the company’s office, left the information exposed in places where an unauthorized person had access, and then abandoned the information altogether.  Over the course of the investigation, OCR found that Lincare had inadequate policies and procedures in place to safeguard patient information that was taken offsite, although employees, who provide health care services in patients’ homes, regularly removed material from the business premises. Further evidence indicated that the organization had an unwritten policy requiring certain employees to store protected health information in their own vehicles for extended periods of time.  Although aware of the complaint and OCR’s investigation, Lincare subsequently took only minimal action to correct its policies and strengthen safeguards to ensure compliance with the HIPAA Rules.” 

The two messages here: Take proper care of paper records, and don’t ignore HHS Office for Civil Rights.

The Notice of Proposed Determination and the ALJ’s opinion may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/lincare/index.html

HHS OIG Report Says Utah Medicaid Systems Had Weaknesses

On February 2, 2016 FierceHealthIT reported that the HHS Office of Inspector General had completed a report in January entitled: INADEQUATE SECURITY MANAGEMENT PRACTICES LEFT UTAH DEPARTMENT OF HEALTH SENSITIVE MEDICAID DATA AT RISK OF UNAUTHORIZED DISCLOSURE.  Once again, the OIG pretty much says it all right there in the title.  This is a study of what happened when a contractor for Utah IT put up a server insecurely and 780,000 people in Utah had their PHI hacked.  The population of Utah is only 2.9 million, so that’s 29% of the state affected.  The news report is at  http://www.fiercehealthit.com/story/oig-weaknesses-utah-department-healths-medicaid-it-systems-high-impact/2016-02-02  

The OIG Report is at: http://oig.hhs.gov/oas/reports/region7/71500455.pdf  

A report on the Utah Breaches is available at: http://www.fiercehealthit.com/story/health-department-breach-impacts-24k-medicaid-patients/2012-04-05   

FDA Provides Cybersecurity Recommendations for Medical Devices

On January 15, 2016 the US Food and Drug Administration (FDA) announced draft guidance on important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.  The announcement is available at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481968.htm  and the guidance, posted January 22, 2016, is available at:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482022.pdf  

In October 2014, the FDA issued guidance for medical device manufacturers regarding building cybersecurity into their product from the beginning of the development process, available at:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356190.pdf  

HIMSS Announces its Healthcare Cybersecurity Community

On January 19, 2016, HIMSS launched its Healthcare Cybersecurity Community for its members, which will provide a forum where healthcare constituents can discuss and learn about advancing the state of cybersecurity in the healthcare industry.

Participation in the community will include monthly discussions via WebEx with healthcare cybersecurity thought-leaders and discussion with peers in the healthcare sector.  In addition, members of the Healthcare Cybersecurity Community can engage and dialogue with each other through a dedicated ListServ.

January Webinar Information: The first Healthcare Cybersecurity Community webinar will occur on January 28, 2016 from 2-3PM ET.  The speaker will be Kevin A. McDonald, BSN, MEPD, GCIS, CISSP, Director of Clinical Information Security at the Office of Information Security of Mayo Clinic.  He will discuss how healthcare providers can effectively address today’s people, process, and technology challenges as they pertain to cybersecurity.  Mr. McDonald will also discuss best practices and reference standards which may be helpful in overcoming these challenges.  Registration information for this event, along with other details about the community, can be found on the HMSS Cybersecurity Community web site, at http://www.himss.org/get-involved/community/cybersecurity.

How to join the community (you must be a member of HIMSS):
1. Log into the HIMSS member portal at https://marketplace.himss.org/My-Account/Participation
2. Under the “My Involvement” tab, click on the "Edit Participations” button.
3. Select "Healthcare Cybersecurity Community" and click on the “Save” button.

After you have completed steps 1 through 3, you will be automatically added to the HIMSS Healthcare Cybersecurity Community itself as well as the ListServ. 

Report Shows 84% of Mobile Health Apps Are Insecure

On January 13, 2016, Healthcare IT News reported that a new report shows 84  percent of U.S. FDA-approved health apps tested by IT security vendor Arxan Technologies did not adequately address at least two of the Open Web Application Security Project top 10 risks.  Most health apps are susceptible to code tampering and reverse-engineering, and 95% of the FDA-approved apps lack binary protection and have insufficient transport layer protection, leaving them open to hacks that could result in privacy violations, theft of personal health information, as well as device tampering and patient safety issues.  The article is available at:  http://www.healthcareitnews.com/news/8-out-10-mobile-health-apps-open-hipaa-violations-hacking-data-theft  

HHS Issues Guidance on Individuals’ Right of Access to PHI

On January 7, 2016, The US Department of Health and Human Services issued new guidance on individuals’ right to access their health information. The guidance includes general information and specifics about the details of proper implementation, and also includes an extensive Q&A section providing additional information.  If this guidance is an indication of the quality of information we should expect from HHS on the Web, it’s a good sign.  If you have questions on providing access under HIPAA, look here first.  http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html  

By the way, this new guidance is provided on the completely revamped HHS Web site, which is now much easier to use and search for information, even on your smart phone.  Happy exploring!  (Yes, I have good things to say about the HHS Web site!)

HIPAA Rule Issued to Ease Reporting to the NICS re Firearms

On January 6, 2016, a new rule was published in the Federal Register to modify HIPAA §164.512, adding a new section (k)(7) to allow use or disclosure of PHI for purposes of reporting to the National Instant Criminal Background Check System the identity of an individual who is prohibited from possessing a firearm.  Disclosures may include only the limited demographic and certain other information needed for purposes of reporting to the NICS, and may not include diagnostic or clinical information.  The new rule is available at:  https://www.federalregister.gov/articles/2016/01/06/2015-33181/health-insurance-portability-and-accountability-act-hipaa-privacy-rule-and-the-national-instant  

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