Archives: OCR

We blogged on this back in early May, but compliance with individuals’ rights to access their PHI under HIPAA is even more critical now that OCR has announced that its current HIPAA audits will focus on an audited Covered Entity’s documentation and process related to these access rights.

In an email sent to listserv participants on July 12, 2016 from OCR-SECURITY-LIST@LIST.NIH.GOV, the U.S. Department of Health and Human Services (HHS) included the following list of areas of focus for the desk audits:

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)]

As discussed in our prior post, HHS issued guidance regarding individuals’ rights to access PHI earlier this year. Here is a link to this PHI access guidance:  Individuals’ Right under HIPAA to Access their Health Information | HHS.gov

The HHS access guidance stresses that Covered Entities should provide individuals with “easy access” to their PHI and cannot impose “unreasonable measures” on the individuals with respect to this right to access. The HHS access guidance provides important information regarding the different rules that apply when an individual provides a signed authorization for release of their PHI versus when an individual is really making a request for access to his or her PHI.

If an individual is asking for the PHI to be provided to him or her, this is really a request for access even if the individual is providing a signed authorization for release of the PHI.

If the individual is asking the PHI to be directed to a third party, this can be either a situation when a signed authorization is needed or can be an access request, depending on who is really originating the request (the individual or the third party). A Covered Entity cannot require an individual to provide a signed authorization to make an access request.  A Covered Entity can require that the access request be in writing and can require use of a form as long as it does not impose undue burden on the individual’s right to access.

The HHS access guidance also indicates that if an individual requests that his or her PHI be provided by email, the Covered Entity is required to do so and further, if the individual requests in writing that the PHI be provided by unsecure, unencrypted email, the Covered Entity is required to do so after notifying the individual in writing of the risks of this method of transmission. (This notice can be included on the access request form.)

As a result of the HHS access guidance, a Covered Entity may need to review and amend its HIPAA Privacy Policies and Procedures governing individual rights with respect to access to PHI, the form it uses for individual access requests, and its employee training protocols to be sure employees aren’t requiring a patient  (or member, in the case of a health plan Covered Entity) to sign an authorization form when the patient is requesting access to PHI.

Jessica Forbes Olson and T.J. Lang write:

In Part 1, we noted that on March 21, 2016, the Office of Civil Rights (“OCR”) announced it will launch a second round of HIPAA audits this year. As with the first round of audits, in round two OCR will be reviewing compliance with HIPAA Privacy, Security and Breach Notification rules. New for this round, the 2016 audits will focus on covered entities, including health care providers and health insurers, and their business associates.

A HIPAA compliance checklist for health care providers and insurers follows:

  • Determine whether for HIPAA purposes you are a hybrid entity, an affiliated covered entity or part of an organized health care arrangement. Document that status.
  • Appoint a HIPAA privacy official.
  • Appoint a HIPAA security official.
  • Appoint a HIPAA privacy contact person who will handle complaints and respond to the exercise of patient or participant rights.
  • Determine where PHI is located, whether hard copy, electronic, or spoken.
  • Determine the reasons why PHI is used or disclosed (e.g., treatment, payment, health care operations, public health reasons, public policy reasons, to government agencies or officials).
  • Determine which departments and workforce members have access to PHI, why they have such access and the level of access needed.
  • Identify and document the routine requests, uses and disclosures of PHI and the minimum necessary for those requests, uses and disclosures.
  • Identify all business associates: vendors that create, maintain, use or disclose PHI when performing services for your entity.
  • Have executed business associate agreements with all business associates.
  • Have and follow written HIPAA privacy, security and breach notification policies and procedures.
  • Train all workforce members who have access to PHI on the policies and procedures and document the training.
  • Have and use a HIPAA-compliant authorization form.
  • Have and follow process for verifying the status of personal representatives.
  • Distribute a notice of privacy practices and providers must attempt to obtain acknowledgment of receipt of notice from patients and post one in each facility where patients can view it.
  • Establish and document reasonable administrative, technical and physical safeguards for all PHI, including hard copy and spoken PHI.
  • Conduct and document a HIPAA security risk analysis for all electronic PHI (e.g., PHI on desktops, laptops, mobile phones, iPads and other electronic notebooks, copy machines, printers, discs and thumb drives).
  • Address risks to ePHI that are identified in the HIPAA security risk analysis.
  • Update your HIPAA security risk analysis periodically or when there is a material change in your environment that does or could impact PHI or if there are changes in the law impacting PHI.
  • Encrypt PHI to fall within the breach safe harbor.
  • Have written disaster recovery and contingency plans.
  • Prepare for and respond to security incidents and breaches.
  • Comply with HIPAA standard transactions and code set rules related to electronic billing and payment.
  • Although it will not be covered by the audits, comply with more stringent state privacy and security laws (e.g., document retention; patient consent; breach reporting).
  • Maintain HIPAA compliance documentation in written or electronic form for at least 6 years from the date the document was created or last in effect.

For more information about OCR audits or assistance in conducting a HIPAA compliance review, please contact any member of the Fox Rothschild Health Law practice group.


Jessica Forbes Olson is a partner and TJ Lang is an associate, both resident in the firm’s Minneapolis office.

Jessica Forbes Olson and T.J. Lang write:

HIPAA and Health Records
Copyright: zimmytws / 123RF Stock Photo

On March 21, 2016, the Office of Civil Rights (“OCR”) announced it will launch a second round of HIPAA audits during 2016. As with the first round of audits, in round two OCR will be reviewing compliance with HIPAA Privacy, Security and Breach Notification rules. New for this round, the 2016 audits will focus on covered entities, including health care providers and health insurers, and their business associates.

The round two audits will occur in three phases: desk audits of covered entities, desk audits of business associates, and finally, follow-up onsite reviews. It is reported OCR will conduct about 200 total audits; the majority of which will be desk audits.

OCR has already begun the process of identifying the audit pool by contacting covered entities and business associates via email.  Health care providers,   insurers and their business associates should be on the lookout for automated emails from OCR which are being sent to confirm contact information. A response to the OCR email is required within 14 days. OCR instructed covered entities and business associates to check their spam or junk email folders to verify that emails from OCR are not erroneously identified as spam.

After the initial email, OCR will send a pre-audit questionnaire to entities it may choose to audit. Receiving a pre-audit questionnaire does not guarantee your entity will be audited. The purpose of the questionnaire is to gather information about entities and their operations, e.g., number of employees, level of revenue, etc. The questionnaire will also require covered entities to identify all of their business associates. Health care providers and insurers who have not inventoried business associates should do so now.

Entities who fail to respond to the initial OCR email or questionnaire will still be eligible for audit. OCR will use publicly available information for unresponsive entities to create its audit pool.

OCR will then, in the “coming months,” randomly select entities to audit and notify them via email that they have been selected for audit.

Health care providers, health insurers and business associates should check their HIPAA compliance status before they are contacted by OCR. Once selected for an audit, entities will only have 10 business days to provide the requested information to OCR.

Recent OCR enforcement activity has shown that noncompliance with HIPAA can be costly:

  • A Minnesota-based hospital entered into a $1.55 million settlement for failure to implement one business associate agreement and failure to conduct a HIPAA security risk analysis;
  • A teaching hospital of a university in Washington entered into a $750,000 settlement for failure to conduct an enterprise-wide HIPAA security risk analysis;
  • An insurance holding company based in Puerto Rico entered into a $3.5 million settlement for failure to implement a business associate agreement, conduct a HIPAA security risk analysis, implement security safeguards and for an improper disclosure of protected health information (“PHI”);
  • A radiation oncology physician practice in Indiana entered into a $750,000 settlement for failure to conduct a HIPAA security risk analysis and implement security policies and procedures.

If you receive any communications from OCR, please contact a member of the Fox Rothschild Health Law practice group immediately. A proactive review of your HIPAA compliance status can identify potential gaps and minimize the risk of potential penalties.

In Part 2, we’ll provide a HIPAA compliance checklist for healthcare providers and insurers. Stay tuned!


Jessica Forbes Olson is a partner and TJ Lang is an associate, both resident in the firm’s Minneapolis office.

“Maybe” is the take-away from recent guidance posted on OCR’s mHealth Developer Portal, making me wonder whether the typical health app user will know when her health information is or is not subject to HIPAA protection.

The guidance is clear and straightforward and contains no real surprises to those of us familiar with HIPAA, but it highlights the reality that HIPAA, originally enacted close to 20 years ago, often becomes murky in the context of today’s constantly developing technology. Here’s an excerpt from the guidance that illustrates this point:

Consumer downloads to her smart phone a mobile PHR app offered by her health plan that offers users in its network the ability to request, download and store health plan records. The app also contains the plan’s wellness tools for members, so they can track their progress in improving their health.  Health plan analyzes health information and data about app usage to understand the effectiveness of its health and wellness offerings.  App developer also offers a separate, direct-to-consumer version of the app that consumers can use to store, manage, and organize their health records, to improve their health habits and to send health information to providers.

Is the app developer a business associate under HIPAA, such that the app user’s information is subject to HIPAA protection?

Yes, with respect to the app offered by the health plan, and no, when offering the direct-to-consumer app. Developer is a business associate of the health plan, because it is creating, receiving, maintaining, or transmitting protected health information (PHI) on behalf of a covered entity.  Developer must comply with applicable HIPAA Rules requirements with respect to the PHI involved in its work on behalf of the health plan.  But its “direct-to-consumer” product is not provided on behalf of a covered entity or other business associate, and developer activities with respect to that product are not subject to the HIPAA Rules.  Therefore, as long as the developer keeps the health information attached to these two versions of the app separate, so that information from the direct-to-consumer version is not part of the product offering to the covered entity health plan, the developer does not need to apply HIPAA protections to the consumer information obtained through the “direct-to-consumer” app.

So if I download this app because my health plan offers it, my PHI should be HIPAA-protected, but what if I inadvertently download the “direct-to-consumer” version? Will it look different or warn me that my information is not protected by HIPAA?  Will the app developer have different security controls for the health plan-purchased app versus the direct-to-consumer app?

HIPAA only applies to (and protects) individually identifiable health information created, received, maintained or transmitted by a covered entity or business associate, so perhaps health app users should be given a “Notice of Non-(HIPAA) Privacy Practices” before inputting health information into an app that exists outside the realm of HIPAA protection.

Matthew Redding contributed to this post.

It’s a familiar story: a HIPAA breach triggers an investigation which reveals systemic flaws in HIPAA compliance, resulting in a seven-figure settlement.  A stolen laptop, unencrypted data, a missing business associate agreement, and an aggressive, noncompliant contractor add to the feeling of déjà vu.

North Memorial Health Care of Minnesota, a not-for-profit health care system, settled with the Office of Civil Rights for the Department of Health and Human Services (OCR) for $1.55 million resulting from allegations that it violated HIPAA by failing to timely implement a Business Associate Agreement with Accretive Health, Inc., a major contractor, and failing to institute an organization-wide risk analysis to address the risks and vulnerabilities to its patient information.

The OCR’s investigation arose following North Memorial’s reporting of a HIPAA breach on September 27, 2011, which indicated that an unencrypted, password-protected laptop was stolen from a workforce member of a business associate’s (BA’s) locked vehicle, impacting the ePHI of almost 10,000 individuals. The investigation further revealed that, North Memorial began providing Accretive with access to its PHI on March 21, 2011, and the parties did not enter into a business associate agreement until October 14, 2011

In addition to the fine, North Memorial is required to develop policies and procedures specific to documenting the BA relationship, modify its existing risk analysis process, and develop and implement an organization-wide risk management plan. The Resolution Agreement is available here.

In a press release, OCR director Jocelyn Samuel said:

“Two major cornerstones of the HIPAA Rules were overlooked by this entity.  Organizations must have in place compliant business associate agreements as well as an accurate and thorough risk analysis that addresses their enterprise-wide IT infrastructure.”

Accretive Health, Inc. may be a familiar name to readers of this blog.  In 2012, the Minnesota Attorney General’s office filed suit against Accretive for allegedly mining, analyzing and using their hospital clients’ data for purposes that were not disclosed to patients and which may adversely affect their access to care.  This suit was subsequently settled for $2.5 million under an agreement under which Accretive agreed to cease operations in Minnesota.  The AG’s lawsuit was triggered by the same laptop theft which compromised the healthcare data of North Memorial and another facility, Fairview Health  Services.  One stolen, unencrypted laptop of a BA has resulted in over $4 million in aggregate liabilities to three covered entities.

The lessons for covered entities from this continuing saga are clear:

  • Encrypt your electronic data. All of it, everywhere it resides and whenever it is transmitted, and pay particular attention to laptops, mobile devices and media.  (While you’re at it, be sure to protect paper data as well and shred it when it is no longer needed  — it can be easily exploited by thieves and dumpster-divers).
  • Make sure you have Business Associate Agreements with all business associates, and review them to make sure they are current and require appropriate safeguards and indemnify you from the costs of the BA’s breaches.
  • Know your BAs and control what they do with your data.  Accretive’s alleged aggressive collection efforts, such as accosting patients on gurneys in the emergency department or while recovering from surgery, did not reflect well on their hospital clients.
  • Do not take your HIPAA obligations lightly.  North Memorial’s incomplete HIPAA implementation and lack of attention to risk analysis may have contributed to the severity of the result.

Our partner Elizabeth Litten and I were quoted by our good friend Marla Durben Hirsch in her article in Medical Practice Compliance Alert entitled “6 Compliance Trends Likely to Affect Your Practices in 2016.” Full text can be found in the January 13, 2016, issue, but a synopsis is below.

For her article, Marla asked various health law professionals to make predictions on matters such as HIPAA enforcement, the involvement of federal agencies in privacy and data security, and actions related to the Office for Civil Rights (“OCR”) of the federal Department of Health and Human Services (“HHS”).

After the interview with Marla was published, I noted that each of Elizabeth’s and my predictions described below happened to touch on our anticipation of the expansion by HHS and other federal agencies of their scope and areas of healthcare privacy regulation and enforcement. I believe that this trend is not a coincidence in this Presidential election year, as such agencies endeavor to showcase their regulatory activities and enlarge their enforcement footprints in advance of possible changes in the regulatory environment under a new administration in 2017. If an agency can demonstrate effectiveness and success during 2016 in new areas, it can make a stronger case for funding human and other resources to continue its activities in 2017 and thereafter.

Our predictions that were quoted by Marla follow.

Kline Prediction: Privacy and data enforcement actions will receive more attention from federal agencies outside of the OCR.

In light of the amount of breaches that took place in 2015, the New Year will most likely see an increase of HIPAA enforcement. However, regulators outside of healthcare –such as the Department of Homeland Security, the Securities and Exchange Commission and the Federal Communications Commission — also try to extend their foothold into the healthcare compliance realm, much in a way that the Federal Trade Commission has.

Litten Prediction: The Department of Justice (DOJ) and the OCR will focus more on individual liability

In September of 2015, the DOJ announced through the Yates Memo, that they would be shifting their strategy to hold individuals to a higher level of accountability for an entity’s wrongdoing. The OCR has also mentioned that they will focus more on individuals who violate HIPAA. “They’re trying to put the fear in smaller entities. A small breach is as important as a big one,” says Litten.

Kline Prediction: OCR will examine business associate relationships.

The HIPAA permanent audit program, which has been delayed by the OCR, will be rolled out in 2016 and will scrutinize several business associates. In turn, all business associate relationships will receive increased attention.   According to Kline, “There will be more focus on how you selected and use a business associate and what due diligence you used. People also will be more careful about reviewing the content of business associate agreements and determining whether one between the parties is needed.”

We shall continue to observe whether the apparent trend of federal agencies to grow their reach into regulation of healthcare privacy continues as we approach the Presidential election.

When and how should you email PHI, if at all?  The Office for Civil Rights (OCR) offers guidance as to the permissibility of sending PHI via email in this “Frequently Asked Question” answer, but doesn’t provide specifics as to how PHI can be safely emailed.  Whether you are a covered entity or a business associate (or the CIO or Privacy Officer for a covered entity or business associate), an attorney trying to navigate privacy and security compliance under HIPAA and other laws, or an individual whose PHI is at stake, you may wonder what tools and resources are available to protect PHI transmitted via email.

The National Institute of Standards and Technology (NIST) has provided many such tools and resources, including its 2007 “Guidelines on Electronic Mail Security”.  Now, though, NIST is accepting comments through November 30, 2015 on its most recent proposed set of email security guidelines, “Special Publication 800-177, Trustworthy Email”.  Though this Trustworthy Email draft (available with other NIST computer security and privacy publications here) comes with a disclaimer that it is “written for the enterprise email administrator, information security specialists and network managers”, it’s worth review (even by the less tech-savvy among us) because it breaks down and describes each component of email functionality and the protocols and technology currently available to improve privacy and security.

Emailing PHI has become extremely common, but before deciding to send or receive PHI via email, it’s a good idea to make sure the Trustworthy Email protocols and technologies have been considered.   And if you have suggestions or comments as to how these protocols and technologies specifically relate to or can be improved in the context of emails containing PHI, here’s your chance to speak up!  Finally, remember that whatever comes out as the final set of NIST guidelines can become obsolete quickly in this rapidly developing and expanding e-world.

Cancer Care Group, P.C., a 13-physician radiation oncology practice in Indiana (group), has agreed to pay $750,000 and implement a comprehensive corrective action plan in a settlement resulting from the theft of a laptop and backup media containing unencrypted patient information.  As is often the case, the breach incident triggered an investigation that revealed deeper deficiencies in the physician group’s HIPAA compliance efforts.  The Office of Civil Rights of the Department of Health and Human Services (OCR) announced the settlement in a September 2, 2015 press release entitled “$750,000 HIPAA settlement emphasizes the importance of risk analysis and device and media control policies.”  That heading alone strongly suggests that OCR chose this case to send a clear and powerful message to smaller covered entities and business associates that neglecting basic compliance efforts can and will result in heavy fines, especially if meaningful corrective action is not undertaken after a breach occurs.

The practice first notified OCR of the theft of an employee’s laptop bag in 2012 from the employee’s car. The bag contained a laptop, which did not contain ePHI, and unencrypted computer server backup media with names, addresses, dates of birth, Social Security numbers, insurance information and clinical information of approximately 55,000 current and former patients.   OCR learned upon further investigation that the group had taken its HIPAA obligations less than seriously for years preceding the breach.

It had not conducted an enterprise-wide risk analysis when the breach occurred in July 2012. Further, Cancer Care did not have in place a written policy specific to the removal of hardware and electronic media containing ePHI into and out of its facilities, even though this was common practice within the organization. OCR found that these two issues, in particular, contributed to the breach, as an enterprise-wide risk analysis could have identified the removal of unencrypted backup media as an area of significant risk to Cancer Care’s ePHI, and a comprehensive device and media control policy could have provided employees with direction in regard to their responsibilities when removing devices containing ePHI from the facility.

In addition to the fine, the group adopted a Corrective Action Plan as part of its Resolution Agreement with OCR, which can be read here.

Much like the Phoenix Cardiac Surgery settlement that we discussed on this blog in 2012, this case involved  not just a one-time negligent breach, but a systematic, ongoing failure to adopt and implement appropriate HIPAA safeguards, policies and compliance efforts.  The Resolution Agreement indicates that such failures continued for a significant time after the theft of the devices.

The Resolution Agreement states that the payment of the $750,000 “Resolution Amount” does not preclude the government from imposing civil monetary penalties in the future if the deficiencies are not cured, and the group agreed to extend the statute of limitations on such penalties during the three-year term of the Resolution Agreement and Corrective Action Plan and for one year afterwards.  During the term of the Agreement, the group is required to complete a comprehensive Risk Analysis of all security risks and vulnerabilities posed by its electronic equipment, data systems, and applications that contain, store, transmit, or receive electronic protected health information (“ePHI”) and report the results to OCR; develop and implement an organization-wide Risk Management Plan to address and mitigate any security risks and vulnerabilities found in the Risk Analysis; revised and update its policies and procedures to OCR’s satisfaction; revise its current Security Rule Training Program; investigate any workforce member’s violation of such policies and report the results to OCR (even if such violation did not result in a breach); and file detailed annual reports with OCR.

There are plenty of lessons to learn from this settlement, but one of the most critical lessons may be the easiest to implement: encrypt your data, particularly any data that is stored in portable devices which have a disturbing tendency to disappear.  Had the backup device been encrypted, it is likely that the outcome of this incident would have been very different. Another lesson is that, if a breach of HIPAA is discovered, be proactive and act immediately to assess and address the risk and mediate the potential damage, update your policies and procedures, implement changes designed to avoid another breach, etc.  Do not wait for OCR to tell you how to respond to the breach.

Our partner Elizabeth Litten and I were once again quoted by our good friend Marla Durben Hirsch in her recent articles in Medical Practice Compliance Alert entitled “Misapplication of Internet Application Triggers $218,400 Settlement” and “Protect Patient Data on the Internet with These 6 Steps.”  The three of us together were able to come up with a number of ideas to assist physicians in improving the likelihood that protected health information (“PHI”) will be more secure. The full text can be found in the August 17, 2015 issue of Medical Practice Compliance Alert, but a synopsis of our input is included below.

Internet applications and files should be included in a physician practice’s HIPAA compliance plan, or a violation may result.  As an example, St. Elizabeth’s Medical Center (“SEMC”) in Brighton, MA recently settled several potential HIPAA violations for $218,400 with the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”).  One of the incidents involved SEMC’s use of an unauthorized internet-based document. The size of this settlement highlights the concerns of OCR about misuse by healthcare providers of internet-based document sharing or other applications.

Some steps to protect patient data on the internet include the following:

  1. Review the internet applications your practice uses. Litten says, “Take steps such as encryption to protect the data when it’s shared, transmitted and stored.”
  2. Ask the application’s manufacturer about its security safeguards. “If a manufacturer claims that (its application) is HIPAA protected, ask what that means,” Litten urges.
  3. Investigate all internal and external complaints and concerns. Kline says, “Expect the government to find out about PHI exposed on the Internet from a third party.”
  4. Keep track of the steps you take to identify and fix the problem. “You do better if you have a history that you endeavored to comply with HIPAA,” says Kline.
  5. Provide a mechanism by which employees can report concerns anonymously. Kline suggests, “You need a private place where people feel they’re not being watched.”
  6. Don’t allow staff to use unauthorized public networks. “Don’t open documents in, say, a Starbucks,” warns Litten.

In summary, in order for physicians to protect their practices, they must be certain that they understand HIPAA obligations with respect to privacy and security in the context of internet application usage.

We know by now that protected health information (PHI) and other personal information is vulnerable to hackers.  Last week, the Washington Times reported that the Department of Health and Human Services (HHS), the agency responsible for HIPAA enforcement, had suffered security breaches at the hands of hackers in at least five separate divisions over the past three years.  The article focused on a House Committee on Energy and Commerce report that described the breaches as having been relatively unsophisticated and the responsible security officials as having been unable to provide clear information regarding the security incidents.

We know it’s not a question of “if” sensitive information maintained electronically will be compromised by a hacking or other type of cyber security incident, but “when” — regardless of who maintains it — and how destructive an incident it will be. Even HHS and its operating divisions, which include both the Office of Civil Rights (OCR), charged with protecting PHI privacy and security, and the Food and Drug Administration (FDA), the country’s principal consumer protection and health agency, are vulnerable.

Just one day before its coverage of the House Committee report on the cyber security vulnerabilities that exist within the very government agencies charged with protecting us, the Washington Times reported on an even more alarming cyber security risk: the vulnerability of common medical devices, such as x-ray machines and infusion pumps, to hacks that could compromise not just the privacy and security of our health information, but our actual physical health.

This report brought to mind a recent report on the ability of hackers to remotely access the control systems of automobiles.  While the thought of losing control of my car while driving is terrifying, the realization that medical devices are vulnerable to hackers while being used to diagnose or treat patients is particularly creepy.  The two situations may present equally dangerous scenarios, but hacking into a medical device is like hacking into one’s physical being.

So while it’s one thing to have PHI or other sensitive information compromised by a hacking incident, it’s much more alarming to think that one’s health status, itself, could be compromised by a hacker.