healthcarecompliance101

Healthcare Compliance 101

Archive for the month “July, 2016”

Phase Two HIPAA Audits Have Begun

July 12, 2016

OCR’s Phase Two HIPAA Audits Have Begun

Phase Two of OCR’s HIPAA audit program, which officially began a couple of months ago, has officially kicked into high gear.   Selected covered entities have now received notification letters regarding their inclusion in the desk audit portion of the audit program.  Letters were delivered on Monday, July 11, 2016 via email to 167 health plans, health care providers and health care clearinghouses (covered entities).  The desk audits will examine the selected entities’ compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules.

The desk audits are focused examinations of documentation of entity compliance with certain requirements of the HIPAA Rules (see table below).  OCR selected these provisions for focus during the desk audits because our pilot audits, as well as our enforcement activities, have surfaced these provisions as frequent areas of noncompliance.  Entities received two email communications, which were sent to the contact information confirmed by the entity during the pre-audit phase of the program. Nevertheless, these emails may be incorrectly classified as spam in the recipient’s email service.  Covered entities should monitor their spam filtering and junk mail folders for emails from OSOCRAudit@hhs.gov.   One e-mail includes a notification letter providing instructions for responding to the desk audit document request, the timeline for response, and a unique link for each organization to submit documents via OCR’s secure online portal. A second email contains an additional request to provide a listing of the entity’s business associates and also provides information about an upcoming webinar, where OCR will explain the desk audit process for auditees and take their questions.    Entities have 10 business days, until July 22, 2016, to respond to the document requests. Desk audits of business associates will follow this fall.

For more information, see http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html.

Requirements Selected for Desk Audit Review

Privacy Rule Notice of Privacy Practices & Content Requirements   [§164.520(a)(1) & (b)(1)]
Provision of Notice – Electronic Notice   [§164.520(c)(3)]
Right to Access  [§164.524(a)(1), (b)(1), (b)(2), (c)(2), (c)(3),  (c)(4), (d)(1), (d)(3)]
Breach Notification Rule Timeliness of Notification  [§164.404(b)]
Content of Notification  [§164.404(c)(1)]
Security Rule Security Management Process —  Risk Analysis  [§164.308(a)(1)(ii)(A)]
Security Management Process — Risk Management  [§164.308(a)(1)(ii)(B)]

 

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Responding to a CyberSecurity Incident

July 2016

Is your Covered Entity or Business Associate Capable of Responding to a CyberSecurity Incident?

Computer security incident response is an important element of an information technology program.  It can assist Covered Entities and Business Associates in promptly detecting breaches, decreasing loss and damage, mitigating the weaknesses that were exploited, protecting the confidentiality, integrity, and availability of data, and restoring IT services back to normal.

HIPAA defines security incidents as attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.  (See the definition of security incident at 45 CFR 164.304).  HIPAA also identifies breaches as, generally, an impermissible acquisition, access, use, or disclosure under the HIPAA Privacy Rule that compromises the security or privacy of the protected health information. (See the definition of breach at 45 CFR 164.402).

According to a survey recently conducted, 43% of the survey respondents lack formal incident response plans and procedures, and 55% percent of them lack formal incident response teams.  Also, 61% of these respondents have experienced a data breach in over the past two years, which included unauthorized access, denial of service, or malware infection.   Cybersecurity-related attacks have continued to rise and become more destructive and disruptive.  According to a different study, in 2014 the average cost to a company suffering a data breach affecting personally identifiable information (PII) was $3.5 million, with an average cost of $145 per individual.

With the constant upsurge of security breaches that involve cyberattacks and as required by the HIPAA Security Rule, Covered Entities and Business Associates should have security incident response capabilities established.  Although effective incident response planning can be a complex task, it should be one of Covered Entities’ and Business Associates’ priorities.

When establishing incident response capabilities, Covered Entities and Business Associates should consider:

Ø  Developing incident response policies , plans, and procedures

An incident response policy assists Covered Entities and Business Associates in having a proper, concentrated, and coordinated approach to responding to incidents. The incident response plan should provide a roadmap for implementing the entity’s incident response capabilities.  The plan should also meet the Covered Entities’ and Business Associates’ distinctive requirements that relates to their mission, sizes, structures, and functions, and identify the necessary resources and management support. Incident response policies and plans should be approved by management and reviewed on an annual basis.

 

The incident response procedures should be based on the incident response policy and plan.  Incident response procedures are outlines of the specific technical processes, tools, techniques, and forms that are utilized not only by the incident response team, but also by staff who need to report an incident.  These procedures should include the entity’s processes for:

  • preparing for incidents;
  • detecting and analyzing incidents;
  • containing, eradicating and recovering from incidents; and
  • conducting post-incident activities and reviews.

 

Ø  Building relationships and setting up plans for communicating with internal and external parties regarding incidents

Building relationships and lines of communication between the incident response team and other groups, both internal and external can be challenging.  Covered Entities and Business Associates should plan the communication with these groups before an incident occurs.

 

Before establishing incident response policies and procedures, the incident response team should first develop relationships and lines of communication with internal groups within its organization, such as the IT department, public affairs office, legal department, internal law enforcement, and management.

 

Also, the incident response team should discuss with its entity’s public affairs office, legal department, and management about sharing information with external groups.  Covered Entities and Business Associates are often required to communicate with external parties regarding an incident and should comply whenever applicable.  External parties could consist of federal agencies, law enforcement, media, internet service providers (ISPs), vendors, or other incident response teams.

 

Ø  Staffing and training
Covered Entities and Business Associates should staff their incident response team with people who have the appropriate skillsets.  These skills could include network administration, programming, technical support, intrusion detection, and CyberSecurity forensic analysis; team members should also possess teamwork and communication skills.

 

Furthermore, incident response team and staff members should be provided with the necessary training to be effective in their roles, and to carry out their responsibilities during an incident or when an incident is suspected.

 

Resources:

National Institute of Standardization and Technology (NIST): http://csrc.nist.gov/publications/PubsSPs.html(Special Publication 800-61, Computer Security Incident Handling Guide)

Office for Civil Rights (OCR): http://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html(HIPAA Breach Notification guida

New Guidance on Ransomware – Protect ePHI

Your Money or Your PHI:  New Guidance on Ransomware

One of the biggest current threats to health information privacy is the serious compromise of the integrity and availability of data caused by malicious cyber-attacks on electronic health information systems, such as through ransomware.  The FBI has reported an increase in ransomware attacks and media have reported a number of ransomware attacks on hospitals. In recognition of the threat that ransomware poses to critical healthcare infrastructure, the Secretary of HHS recently sent the attached letter to chief executive officers (CEOs) of companies in the health care sector.  This letter highlights the importance of robust security compliance to combat ransomware attacks.

To help health care entities better understand and respond to the threat of ransomware, the HHS Office for Civil Rights today released new Health Insurance Portability and Accountability Act (HIPAA) guidance on ransomware. The new guidance reinforces activities required by HIPAA that can help organizations prevent, detect, contain, and respond to threats, including:

  • Conducting a risk analysis to identify threats and vulnerabilities to electronic protected health information (ePHI) and establishing a plan to mitigate or remediate those identified risks;
  • Implementing procedures to safeguard against malicious software;
  • Training authorized users on detecting malicious software and report such detections;
  • Limiting access to ePHI to only those persons or software programs requiring access; and
  • Maintaining an overall contingency plan that includes disaster recovery, emergency operations, frequent data backups, and test restorations.

 

Some of the other topics covered in the guidance include: understanding ransomware and how it works; spotting the signs of ransomware; implementing security incident responses; mitigating the consequences of ransomware; and the importance of contingency planning and data backup.  The guidance makes clear that a ransomware attack usually results in a “breach” of healthcare information under the HIPAA Breach Notification Rule.  Under the Rule, and as noted in the guidance, entities experiencing a breach of unsecure PHI must notify individuals whose information is involved in the breach, HHS, and, in some cases, the media, unless the entity can demonstrate (and document) that there is a “low probability” that the information was compromised.

Ransomware is a type of malware (malicious software) that encrypts data with a key known only to the hacker and makes the data inaccessible to authorized users. After the data is encrypted, the hacker demands that authorized users pay a ransom (usually in a cryptocurrency such as Bitcoin to maintain anonymity) in order to obtain a key to decrypt the data. Ransomware frequently infects devices and systems through spam, phishing messages, websites, and email attachments and enters the computer when a user clicks on the malicious link or opens the attachment.

Organizations need to take steps to safeguard their data from ransomware attacks. HIPAA covered entities and business associates are required to develop and implement security incident procedures and response and reporting processes that are reasonable and appropriate to respond to malware and other security incidents.

The guidance can be found at: http://www.hhs.gov/sites/default/files/RansomwareFactSheet.pdf. Please feel free to share the attached letter, and the link to the new HIPAA guidance, with interested colleagues.

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