While your business may indeed be a “victim” when hit by a phishing attack, your enterprise can also be responsible for violations of law associated with the incident.   Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried out by accessing MCPN employees’ email accounts, gave a hacker access to the electronic protected health information (“ePHI”) of 3,200 individuals. In investigating the breach, OCR determined that, prior to the breach, MCPN had not conducted a security risk analysis (a requirement under HIPAA). Further, OCR found that even after MCPN conducted a risk analysis, its analysis was insufficient to meet the requirements of the HIPAA Security Rule.

In addition to the $400,000 fine, MCPN agreed to a corrective action plan with OCR. That plan requires MCPN to conduct a comprehensive risk analysis and to submit a written report on the risk analysis to OCR. Additionally, MCPN will be required to develop an organization-wide risk management plan, to review and revise its Security Rule policies and procedures, to review and revise its Security Rule training materials, and to report to OCR any instance of a workforce member failing to comply with its Security Rule policies and procedures.

The MCPH settlement underscores the importance of risk analyses and workforce training to avoid phishing scams. Additionally, it is crucial that entities regulated by HIPAA conduct an enterprise-wide HIPAA risk analysis, update that analysis to address new threats, and implement policies and training based on identified risks. Failure to comply with these essential HIPAA requirements can turn a relatively routine breach investigation into a $400,000 settlement.

A copy of the MCPN resolution agreement and corrective action plan is available here. OCR’s press release on the settlement is available here. General Security Rule guidance from OCR is available here.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR)  recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA.  The OCR warning applies generally to HIPAA Covered Entities and Business Associates.  While Covered Entities and Business Associates are more cognizant of vulnerabilities in operating systems (like Windows) and install updates and patches as needed (we hope), OCR reported that companies are less likely to do the same for third-party applications (like Adobe’s Acrobat or others). Continue Reading OCR Warns of HIPAA Risks in Third-Party Apps

At long last, the Department of Health and Human Services Office for Civil Rights (OCR) has released a revamped audit protocol that now addresses the requirements of the 2013 Omnibus Final Rule. OCR will be using the audit protocol for its impending Phase 2 audits of covered entities and business associates, which are set to begin next month.

The protocol covers the following subject areas:

  • Privacy Rule requirements for (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.
  • Security Rule requirements for administrative, physical, and technical safeguards.
  • Breach Notification Rule requirements.

OCR has also released other materials that shed light on the logistics of the audit process, including a copy of the Audit Pre-Screening Questionnaire that it will use to collect demographic information about covered entities and business associates. OCR will use this information to create a pool of potential auditees.

Entities selected for audit will be required by OCR to identify and provide detailed information regarding their business associates.  The information collected by OCR will be used to help identify business associates for the Phase 2 audits. OCR has released a template with the information that covered entities will have to provide, including the business associate’s name, contact information, type of services, and website.

Covered entities and business associates should be working to ensure that they have the required compliance documents and materials ready, especially given OCR’s aggressive timetable: if selected for an audit, an auditee will have only 10 days to respond to OCR.

As we have discussed previously on this blog, the audit protocol is an excellent HIPAA compliance tool, especially for audit readiness assessment.  Unfortunately, the version of the tool on the OCR website can be unwieldy to use in practice.   In order to assist covered entities and business associates with their HIPAA compliance efforts, we have repackaged the audit protocol into a more user-friendly format that can be downloaded here.

 

Originally posted to Mintz Levin’s Health Law & Policy Matters Blog on 4/20/16

The First Rule of How to Survive a HIPAA Audit:  Be Prepared

2015 is bringing along with it the start of the HHS Office for Civil Rights random audit program to assess compliance with the HIPAA privacy, security and breach notification rules.   It is anticipated that 300-400 business associates will be the subject of a desk audit and an undisclosed number of lucky business associates and covered entities will be chosen for intensive, on-site audits.  Remember, if your business provides services to a healthcare entity covered by HIPAA, you are likely a business associate.

So, here’s the question:  are you audit-ready?  

In a free webinar, Mintz Levin’s Dianne Bourque will walk you through how to prepare now in the event that you are one of the chosen.

Save the date:   Wednesday, January 28, 2015   1:00 PM ET/10:00 AM PT

Registration information will follow!

 

 

Reposted from Mintz Levin’s Health Law & Policy Matters blog

The American Bar Association Health Law Section’s July 2014 eSource publication includes an article by Dianne Bourque, Kimberly Gold, and Stephanie Willis that provides examples of how risk assessments under the Breach Notification Rule have changed since the HIPAA Omnibus Rule went into effect in September 2013.   The examples analyzed in this article involve two situations that often stymie health care providers:  1) appropriate disclosures to law enforcement and 2) sending appointment reminders to patients.

Covered entities and business associates having difficulty distinguishing the old “harm standard” and the new Omnibus Rule analysis should understand that the latter clearly imposes a rebuttable presumption that a breach of protected health information will require notification to affected individuals and the government, except under narrow circumstances.  As the article concludes, “striking a balance between an inquiry that meets the risk assessment’s requirements but that minimizes the over-reporting of breaches will be a challenge that covered entities and business associates will need to address” for years to come.

Mintz Levin’s Privacy team constantly monitors the HHS Office of Civil Rights’ enforcement and monitoring activities and writes posts noting trends in the area of HIPAA compliance, so keep checking the blog for current health care privacy and security news.

As we pore through the 562-page HITECH Omnibus Rule released by the Department of Health and Services late yesterday afternoon, here are some top line bullet points:

  • Effective Date:  Rule becomes effective on March 26, 2013.  Covered entities and business associates must comply by September 23, 2013.
  • Business Associates are now front and center — During its announcement yesterday, Leon Rodriguez, director of the HHS Office for Civil Rights (OCR) clearly pointed out that “some of the largest breaches” reported to the agency have involved business associates.    The Omnibus Rule applies all of the HIPAA Security Rule standards and implementation specifications and certain HIPAA Privacy Rule provisions directly to business associates and it adds “subcontractors” to the definition of “business associate” and requires business associates to enter into written contracts with subcontractors that are substantially similar to business associate agreements.   Although there is a bit of a runway before effectiveness of the provisions, there is no time to waste for companies to determine (a) whether they are indeed “business associates” under this new, expanded view (may be some surprises), and (b) if you are a BA, how far down your technology “stack” you may have to go under the Omnibus Rule to determine who are your “subcontractors.”   Also, this is a good time for covered entities to get busy to determine and catalog exactly who is a “business associate” for their purposes.   Risk assessments and gap analyses always take more time than estimated.   OCR’s comments yesterday are consistent with its view that business associate compliance with HITECH is poor, resulting in breaches and other security incidents jeopardizing patient privacy.  During the public comment period, entities filed comments requesting additional time and assistance for business associates and subcontractors.  In response, OCR provided a link to pre-existing compliance guidance.
  • Breach Notification:  Omnibus Rule replaces the current version of the HIPAA Breach Notification Rule with a new version stating that an acquisition, access, use, or disclosure of PHI not permitted under the Privacy Rule is presumed to be a breach unless a covered entity or business associate can demonstrate a low probability that the PHI has been compromised based on a four-factor risk assessment.
  • Enforcement:  The Omnibus Rule incorporates the increased and tiered civil money penalty structure provided by the HITECH Act with penalties based on the level of negligence with a maximum penalty of $1.5 million per violation.

Director Rodriguez was clear in his statement yesterday:  “This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented.  These changes not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a health care provider, or one of their business associates.”

More to come in the days and weeks ahead.

As originally posted in Mintz Levin’s Health Law & Policy Matters blog

Written by: Stephanie D. Willis The Department of Health and Human Services, Office for Civil Rights (OCR) reached its first settlement for a breach involving data regarding less than 500 individuals.  Under the December 2012 settlement, the Hospice of North Idaho (HONI) will pay OCR a $50,000 penalty to resolve allegations that it violated the HIPAA Security Rule.  The breach occurred in June 2010 with the theft of an unencrypted laptop computer containing the electronic protected health information (ePHI) of 441 HONI patients. OCR investigated the breach after HONI disclosed it in its annual report of breaches that involved less than 500 individuals required under the HITECH Act.The Resolution Agreement subjects HONI to a two-year Corrective Action Plan (CAP), whereby it must closely monitor and promptly investigate any potential violations of HIPAA Privacy and Security policies and procedures by its employees.  If HONI determines that a violation (Reportable Event) occurred, it must report the details of the investigation and all corrective action taken to address the Reportable Event to OCR within 30 days. (We note that it is unclear whether the 30-day countdown starts from the date the Reportable Event occurred or from the conclusion of the investigation.)  Within 30 days of the end of each year the CAP is in place, HONI must notify OCR if no Reportable Events have occurred during the preceding year.

Providers may learn three lessons from the HONI resolution:

  1. OCR pays attention to the annual reports of breaches required under the Breach Notification Rule;
  2. no breach is “too small” for OCR enforcement action; and
  3. mobile device and laptop security is a continued concern for OCR.

Again, the risks related to the use of mobile devices like laptops, PDAs, and smartphones are well-known and have been addressed in previous blog posts both here and in our Health Law & Policy Matters blog on “bring your own device” policies and the Massachusetts Eye and Ear Infirmary resolution (also stemming from a self-reported breach).    As OCR Director Leon Rodriguez emphasized in the HONI resolution press release, “Encryption is an easy method for making lost information unusable, unreadable and undecipherable.” The HONI resolution shows that OCR will continue to address all breaches, large or small.

 

Originally posted by Dianne Bourque in Mintz Levin’s Health Law & Policy Matters blog

As the old saying goes, “no good deed goes unpunished….”    The most recent, published Office for Civil Rights (OCR) HIPAA enforcement action serves as an important reminder that self-reported breaches can and do lead to investigations and enforcement.

Massachusetts Eye and Ear Infirmary was following the HITECH breach notification rules when it reported the theft of an unencrypted laptop in 2010.  The laptop contained the protected health information of MEEI patients and research subjects, including prescription and health information.  OCR investigated the breach and brought an enforcement action, citing MEEI for a number of HIPAA security rule violations.  Not unexpectedly, OCR was focused on laptop security and the security of portable devices generally, which has been an enforcement priority of OCR.

The MEEI enforcement provides other important reminders for covered entities:

1. Avoid breaches and breach notifications which can lead to investigations.

2. Encrypt laptops and other portable devices.

3. Keep track of portable devices.

4. The OCR trend toward seven-figure fines is continuing (the MEEI settlement was $1.5 million).

The read the MEEI resolution agreement, click here.  The related OCR press release is here.

The upcoming HIPAA Omnibus Rule is poised to transform an already challenging privacy and security landscape for business associates or those who provide services to HIPAA “covered entities.” The HITECH Act has already imposed greater compliance responsibility on business associates and their subcontractors. The rules are set to change further and failure to comply can result in compliance reviews, investigations, seven figure financial penalties, and other sanctions. In fact, the Office for Civil Rights, the agency responsible for HIPAA enforcement, recently announced concerns regarding business associate HIPAA compliance and plans to target business associates in upcoming audits.

If this is not enough to keep your privacy officer and security officers busy, there are overlapping, and continually evolving, state data security laws that must be evaluated along with HIPAA in order to ensure full compliance with privacy and security requirements. It is critical to protect your organization on all fronts with respect to these laws.

Mintz Levin is following the developments related to the final HIPAA Omnibus Rule closely, and we will hold a webinar on the final Rule within days of its release.  Watch this space for the announcement!

 

Written by Dianne J. Bourque

Last week at the OCR/NIST conference, Building Assurance through HIPAA Security, Linda Sanches of the Office for Civil Rights provided an extensive update on the pilot HITECH audit program, including preliminary findings,  what regulated entities can expect next and suggestions for covered entities concerned about being audited.  Mintz Levin attended the conference and is pleased to share some of the highlights below:

The initial round of audits included 8 health plans, 10 providers, and 2 clearinghouses.

  • Providers had the most findings (81%).  Provider findings were both privacy and security related.
  • The most common privacy findings included misuse of the PHI of deceased individuals, compliance with the patient confidential disclosures right, disclosures for judicial  proceedings, compliance with the patient access right, failure to follow policies and procedures, no evidence of policy and procedure implementation, insufficient policies and procedures, failure to review and update policies on an ongoing basis, and failure of the organization to prioritize HIPAA compliance.

For more on the OCR HITECH audits, see our complete post at the Mintz Levin Health Law Policy Matters blog.