HHS Releases Security Risk Assessment Tool

Need help performing your HIPAA/Meaningful Use Security Risk Assessment?  Good news, HHS has released a tool to help!  In partnership with the Office of the National Coordinator, HHS created a tool, user guide, software, tutorial, videos and even an iOS App to help HIPAA covered entities and business associates perform the required HIPAA Risk Analysis.

The HIPAA Security Rule specifically requires (this is not an addressable specification) a Security Risk Analysis:

“Risk analysis (Required). Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.”  45 CFR 164.308(a)(1)

In addition, those hospitals and eligible professionals seeking to meet meaningful use in order to receive the EHR Incentive dollars or avoid the Medicare payment adjustments must fulfill a HIPAA Security Risk Assessment.

Stage 1

Stage 2

Objective. Protect electronic health information created or maintained by the certified EHR technology through the implementation of appropriate technical capabilities.Measure. Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process. Objective. Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities.Measure. Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in Certified EHR Technology in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the EP’s risk management process.

For those hospitals and eligible professionals looking to meet meaningful use, the Security Risk Assessment tool will generate a report that can be provided to auditors.  However, the report alone is likely insufficient because both the auditors and the  meaningful use requirements (above) require the correction of security deficiencies – so merely running a Security Risk Assessment without taking actions to remedy the problem will not suffice.  To read more about meaningful use audits and security risk assessments click here

In addition to releasing the Security Risk Assessment tool, HHS has created a helpful true/false statement with the Top 10 Myths of Security Risk Analysis.  This document highlights the misconceptions regarding the risk assessment requirements, including that all covered entities and business associates (regardless of the size) must conduct a risk assessment pursuant to HIPAA.  Importantly, though only covered entities are eligible for meaningful use incentives and Medicare payment adjustments, business associates must also comply with the HIPAA Security Rule pursuant to the HITECH Act.  Therefore, business associates must also conduct security risk assessments, and per recent guidance from HHS, business associates are likely part of the next round of HIPAA audits.

For more information about HIPAA, security risk assessments, and meaningful use please contact Elana Zana.

HHS Deadline for HIPAA Breach Notification Reporting

As part of the HITECH revisions to HIPAA, providers are required to report all HIPAA breaches, regardless of the number of individuals affected to HHS on an annual basis.  The deadline for this report is Saturday, March 1st, 2014.  This reporting requirement is pursuant to the Omnibus HIPAA Rule published in January of 2013.  Providers who have had breaches affecting less than 500 individuals can report the HIPAA breaches here.  This report needs to be filled out for each breach that occurred during the 2013 calendar year.  For example, if a covered entity had a breach in April of 2013 affecting three individuals and another breach in December 2013 affecting two individuals the report must be submitted for each breach but not for each individual (a total of two reports would be submitted in this example).  To fill out this form covered entities will need to submit the following information about the breach:

  • General information regarding the covered entity
  • Whether the breach occurred at or by a Business Associate and the associated contact information for that Business Associate
  • Date of the Breach
  • Date of Discovery
  • Approximate number of individuals affected by the Breach
  • Type of Breach (i.e. theft, loss, unauthorized access, etc.)
  • Location of breached information (i.e. laptop, e-mail, etc.)
  • Type of Protected Health Information involved in the Breach (i.e. demographic, financial, etc.)
  • Description of the Breach
  • Safeguards in place prior to the Breach (i.e. firewalls, physical security, etc.)
  • Date individuals were notified of the Breach
  • Whether substitute notice was required (this requirement is described in the rule)
  • Whether media notice was required (this requirement is described in the rule)
  • Actions taken in response to the Breach (sanctions, mitigation, etc.)
  • Any additional actions taken
  • Attestation

For those covered entities that have had a breach which affected more than 500 individuals, this report should have been submitted no later than 60 days following discovery of the breach in accordance with the Breach Notification Rule.

If you have questions regarding filling out this report or on Breach Notification in general please contact Elana Zana or Dave Schoolcraft.

Stolen Thumb Drive Proves Costly for Dermatology Practice

The Department of Health and Human Services (HHS) recently announced a $150,000 settlement with a dermatology practice in Massachusetts that arose out of a stolen thumb drive.  The unencrypted drive, which contained the health information of approximately 2,200 individuals, was stolen from a vehicle of one of the practice’s staff members.

Although HHS was concerned with the staff member’s failure to safeguard the health information, the large settlement amount resulted primarily from the practice’s lack of HIPAA policies and procedures.  Specifically, HHS determined that the practice: (1) had no breach notification policies, (2) had not conducted risk assessments for potential security vulnerabilities, and (3) did not adequately perform HIPAA training for its workforce.

This case provides an important warning to health care providers who do not have comprehensive HIPAA and HITECH policies and procedures.  Although the risk of being selected for an HHS HIPAA audit is still relatively low, it only takes one breach of health information for HHS to open an investigation that can result in costly penalties.

For more information about HIPAA and HITECH policies and procedures, please contact Casey Moriarty.

 

Reducing the Risks of Third-Party Access to EHR Systems

UnityPoint Health, a health system located in Iowa, recently informed 1,800 patients of a breach of their health information.  UnityPoint learned of the breach after an audit discovered that a third party contractor’s employee had improperly gained access to the UnityPoint electronic health record (EHR) system and viewed the records of the 1,800 patients.

The UnityPoint breach shows the risks of allowing a third party contractors, known as “business associates,” to access health information in an EHR system  While such access may be required for certain activities, including billing, claims management, or utilization review, providers must be certain that the business associate agreements with such contractors include strong protections for the provider.

For example, business associate agreements should include requirements for the business associate to indemnify the provider for expenses resulting from HIPAA breaches, pay all notification costs associated with such breaches, and maintain insurance policies that provide coverage for a large breach.

Although strong language in a business associate agreement provides legal protection for a provider, it will do nothing to counteract the public relations fallout that results from notifying patients of a breach.  Therefore, providers should make every effort to contract with legitimate entities that understand HIPAA compliance.

If you would like more information about HIPAA compliance, please contact Casey Moriarty.

Stolen Laptop Leads to Stanford’s Fifth HIPAA Breach

Earlier this month Stanford reported its 5th HIPAA breach since 2009.  This is Stanford’s third largest breach, affecting nearly 13,000 patients.   A broken laptop containing protected health information of pediatric patients was stolen from a restricted area of the Lucile Packard Children’s Hospital at Stanford.  The laptop was un-encrypted and contained patient information including: name, medical record number, age telephone numbers, surgical procedures and treating physicians.  Though the laptop had a broken screen, there is still the possibility of extracting the data from the computer.

Stanford’s other breaches include a disclosure  of 20,000 patient records when a subcontractor of a business associate placed patient information on the web seeking assistance with using Excel, the data was left on the website for nearly a year.  This breach has resulted in a $20 Million class action law suit under California law.

Earlier this year, Stanford announced its largest breach, affecting 57,000 patient records when an unencrypted laptop with patient information was stolen from a physician’s car.  In addition, Stanford reported a breach in 2012 of 2,500 patient records following the theft of an unencrypted laptop from a physician’s office.  Lastly, in 2010, Stanford was hit with a fine after failing to notify the state of California of the theft of a laptop by an employee containing over 500 patient records.

Considering Stanford’s previous breaches, encryption of its laptops would be a good course of action to prevent future HIPAA data breaches.  Stanford has reported that it now encrypts its laptops, but the one that was most recently stolen was unencrypted because the screen was broken.

Lessons learned from Stanford’s misfortunes:  encrypt all PHI and destroy broken devices (remember though broken, the data is still valuable to thieves).

For assistance with  HIPAA and/or the breach notification rules please contact Elana Zana.

The HITECH Act Final Rule’s GINA-Related Modifications to HIPAA

The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits health insurers and health plans from discriminating against beneficiaries on the basis of genetic information.  The HITECH Act Final Rule makes some important GINA-related changes to HIPAA.

In general, the changes related to genetic information are solely of interest to health insurers and health plans.  With that said, the Final Rule’s amendment to the definition of “health information” to include genetic information is relevant to all covered entities.  Under this new definition, all HIPAA covered entities must ensure that the following information is protected and secured under the HIPAA Privacy and Security Rules:

1. Any information related to genetic tests of an individual.

2. The genetic tests of family members of an individual.

3. The manifestation of a disease or disorder in family members of an individual. “Manifestation” means a disease, disorder, or pathological condition that an individual has been or could reasonably be diagnosed with by a health care professional with appropriate training and expertise in the field of medicine involved.

4. Any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by an individual or any family member of the individual.

Additional GINA-related changes to HIPAA under the Final Rule include an explicit prohibition on the use or disclosure of genetic information for a health insurer’s or health plan’s underwriting purposes. There is an exception for underwriting performed by issuers of long-term care policies.

The Final Rule also requires a health plan or health insurer to include a statement in its notice of privacy practices that it will not use or disclose genetic information of an individual for underwriting purposes. Again, there is an exception for issuers of long-term care policies.

If you would like more information about the Final Rule’s GINA-related modifications to HIPAA, please contact Casey Moriarty.

The HITECH Act Final Rule’s Requirements for Using Health Information for Fundraising Purposes

With the HITECH Act Final Rule’s required revisions to business associate agreements, notices of privacy practices, and breach notification policies, it is easy to miss the Final Rule’s changes to the requirements for the use or disclosure of protected health information (PHI) for fundraising purposes.  The new fundraising requirements under HIPAA and the HITECH Act are a mixed bag for covered entities.  Some of the changes increase the ability for covered entities to use PHI for fundraising, while other changes impose more restrictions on covered entities.

One of the benefits of the Final Rule for covered entities is the expansion of the types of PHI that can be disclosed to a business associate or institutionally-related foundation for fundraising purposes.  This list now includes:

1. Demographic information, including name, address, other contact information, age, gender, and date of birth;

2. Dates of healthcare provided to an individual;

3. Department of service information (e.g., cardiology, oncology, pediatrics, etc.);

4. Treating physician;

5. Outcome information (including death or sub-optimal treatment); and

6. Health insurance status.

Additionally, although a covered entity may not send fundraising communications to patients who have opted out of receiving such communications (as explained below), a covered entity may give patients the opportunity to opt back in to receiving such communications.   For example, a covered entity could include, as a part of a routine newsletter sent to all patients, a phone number that patients can call to be put on a fundraising list.

While these changes could be beneficial for covered entities, the Final Rule also has a number of increased requirements relating to fundraising communications, including:

1. Notice of Privacy Practices: The Final Rule requires a covered entity to have an explicit statement in its notice of privacy practices that an individual can opt out of receiving fundraising communications.

2. Opt Out Notice: With each fundraising communication made to patient, a covered entity must include a “clear and conspicuous” opportunity for the patient to opt out of receiving future fundraising materials.  The opt out method must not cause the individual to incur an “undue burden or more than nominal cost”.  Examples of a valid opt out methods include a toll-free number, or the provision of pre-paid, pre-printed postcards.  If an individual opts out of fundraising communications, it is a HIPAA violation for a covered entity to send such a communication to the individual in the future (unless the individual later opts back in to receiving fundraising communications).

3. Conditioning Payment or Treatment: The Final Rule makes it clear that covered entities may not condition treatment or payment on a patient’s decision to receive fundraising communications.

Please contact Casey Moriarty if you have any questions about the use of PHI for fundraising purposes under the HITECH Act Final Rule.

Health Data Privacy Protections to Increase

As we wait for the HITECH Act updates to HIPAA to be finalized, yet another article signals the administration’s intent to strengthen privacy protections for health data– http://www.nytimes.com/2011/05/31/business/31privacy.html

Impact of “Big Data” in Health Care

A Recent report from McKinsey & Company on the evolution of information technology focuses on health care as a sector to watch: “For instance, if US health care could use big data creatively and effectively to drive efficiency and quality, we estimate that the potential value from data in the sector could be more than $300 billion in value every year, two-thirds of which would be in the form of reducing national health care expenditures by about 8 percent.” Full report at http://www.mckinsey.com/mgi/publications/big_data/index.asp

HHS Says Push for EHRs Overlooks Security Gaps

It seems HHS is laying the groundwork for the issuance of the updates to HIPAA privacy and security rules under the HITECH Act.  As reported May 16th in the Washington Post:

“The nation’s push to computerize medical records has failed to fully address longstanding security gaps that expose patients’ most sensitive information to hackers and snoops, government investigators warn.”

http://www.washingtonpost.com/politics/hhs-inspector-general-says-push-for-electronic-medical-records-overlooks-some-security-gaps/2011/05/16/AFpaH54G_story.html