The Joint Commission Issues Clarification on Texting of Patient Care Orders

“The use of secure text orders is not permitted at this time.”

In 2011, the technology to provide for the safety and security of text messaging was not available and, at that time, The Joint Commission (“TJC”) said it was not acceptable for practitioners to text orders for patient care and treatment. Then, in May 2016, TJC revised its position in recognition of technological advances and said physicians could text message when done in accordance with standards of practice, laws, regulations, policies and practices “as long as the system met specific requirements.”

Since then, however, TJC got together with the Centers for Medicare & Medicaid Services (CMS) and issued updated recommendations that include the following:

  • Providers should have policies prohibiting the use of unsecured text messaging of protected health information (PHI).
  • CPOE (computerized provider order entry) should be the preferred method for submitting orders, which are directly entered into the electronic health record.
  • The use of secure text orders is not permitted at this time.

This turnaround came after TJC and CMS discussed the issues with numerous stakeholders, including text messaging platform vendors and experts in electronic health records (EHRs). The identified concerns for maintaining the existing status quo were:

  • Increased burden on nurses to manually transcribe text orders into the EHR.
  • Verbal orders are preferred when CPOE not used, because they allow for real-time clarification and confirmation of the order as it is given by the practitioner.
  • Text messaging could cause delay in treatment where a clinical decision support (“CDS”) recommendation or alert is triggered during data entry, requiring the nurse to contact the practitioner for additional information.

To view the full text article on the TJC website click here.

Failure to Update Business Associate Agreement Leads to Health System’s Settlement with OCR

A hospital’s breach notification to the Department of Health and Human Services, Office of Civil Rights (“OCR”) led to a Resolution Agreement, payment of $400,000 and a Corrective Action Plan for an east coast health system. On September 23, 2016, OCR issued a press release advising that Woman & Infants Hospital of Rhode Island (“WIH”) a member of Care New England Health System (“CNE”) notified OCR of a reportable breach in November of 2012, stemming from its discovery that unencrypted backup tapes containing electronic Protected Health Information (“PHI”) were missing from two of its facilities. CNE provides centralized corporate support to the covered entities under its common ownership and control, including technical support and information security for WIH’s information systems, as its business associate. Although WIH had in place a business associate agreement (“BAA”) with CNE, it was dated from March of 2005 and had not been updated since implementation and enforcement of the HIPAA Omnibus Final Rule.

OCR’s investigation of WIH’s HIPAA Compliance program, triggered by the report of the missing tapes, uncovered the outdated BAAs. WIH updated their BAA on August 28, 2015, as a result of OCR’s investigation. OCR then determined that from September 23, 2014, the date enforcement of the Final Rule began, until August 28, 2015, WIH impermissibly disclosed the PHI of at least 14,004 individuals to its business associate when WIH provided CNE with access to PHI without obtaining satisfactory assurances, in the form of a written business associate agreement, that CNE would appropriately safeguard the PHI. The settlement was reached without any admission of liability by CNE or WIH.

The settlement is a jolt to many covered entities and their business associates for a number of reasons. The key take-aways are: (1) There is an inference in the OCR’s actions that a well worded BAA, wherein the business associates agrees to abide by the specifications required by the Privacy and Security Rules, is sufficient to satisfy the covered entity’s obligation to obtain “satisfactory assurances” the business associate will appropriately safeguard the PHI (meaning those often lengthy and burdensome security questionnaires or audits business associates are being asked to complete may be unnecessary and not required); (2) documentation of intent and action, including policies, procedures and BAAs, is extremely important in establishing HIPAA Compliance (i.e., the fact that the mistake occurred—tapes went missing—is being treated as the result of the absence of a written agreement, justifying the enforcement action, when in reality it is likely, or at least conceivable, that human error, inadvertence or lack of attention is the root cause and this could have occurred even if an updated BAA was in place and being followed); and (3) policies, procedures and continuous training and retraining of the workforce handling PHI is imperative to a successful HIPAA compliance program, and remains on the radar of any OCR investigation.

A copy of the Resolution Agreement and Corrective Action Plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/wih.
OCR’s sample BAA may be found at http://www.hhs.gov/hipaa/for-professionals/covered-entities/sample-business-associate-agreement-provisions/index.html.

Arizona Anesthesia Group Notifies 882,590 Patients of Data Breach

Valley Anesthesiology and Pain Consultants (“VAPC”), a physician group of more than 200 anesthesiologists and pain management specialists with several locations near Phoenix, Arizona, began notifying patients on August 11, 2016, of a potential data breach involving protected health information (“PHI”), despite the fact their retained forensic consultant found no evidence that the information on the computer system was accessed. However, the consultant was unable to definitively rule that out after investigation, and it did confirm that an individual gained access to a system containing PHI. The physician group elected to take the proactive route of notifying affected individuals. The forensic firm was apparently called in shortly after VAPC learned on June 13, 2016, that a third party may have gained unauthorized access to VAPC’s computer system on March 30, 2016, including records of 882,590 current and former patients, employees and providers.

On its website, VAPC says they value their relationship with patients and so decided to mail the notification letters. Law enforcement was also advised, and a dedicated call center has been set up to answer patients’ questions. Patients have been advised to review the statements they receive from their health insurer and to advise the insurer of any unusual activity. The computer system accessed is believed to have contained patient names, limited clinical information, name of health insurer, insurance identification numbers, and in some instances, social security numbers (“SSN”). No patient financial information was included in the computer systems. For providers, the information included credentialing information such as names, dates of birth, SSN, professional license numbers, DEA (Drug Enforcement Agency) and NPI (National Provider Identifier) numbers, as well as bank account information and potentially other financial information. The employee records on the system included names, dates of birth, addresses, SSNs, bank account information and financial information. Individuals that had their SSN or Medicare number exposed are being offered credit monitoring and identity theft protection services.

The circumstances of the incident illustrate the quandary regarding the presumption that it is a reportable breach if you can’t prove there was no access to the information, and the interplay between the HIPAA Security Rule and the Privacy Rule. Here, it was apparently established the system’s security was breached, but unclear whether personal health information was accessed once the unauthorized individual was in the system.

More information is available on VAPC’s website: https://valley.md/securityupdate.

Ransomware: Preparing for the Storm That’s A Brewin’

On July 11, 2016, the Office for Civil Rights (“OCR”) published guidelines for ransomware attack prevention and recovery, including the role HIPAA has in assisting covered entities and business associates prevent and recover from such attacks, and how HIPAA breach notification processes should be managed in response to a ransomware attack. According to the OCR report, there have been 4,000 daily ransomware attacks since early 2016, up 300% from 2015. Earlier this week a healthcare IT Security Consultant told me the chatter he hears is the hackers are working on stronger, more aggressive, more deadly hacks to unleash, and he fears a hacking storm a brewin’. Time to get serious and batten down the hatches, folks!

8-3The OCR report describes what a ransomware attack is, and explains that maintaining strict HIPAA Security Rule compliance can help prevent the introduction of malware, including ransomware. Some of the required security measures discussed include:

  • Implementing a security management process, which includes conducting a risk analysis and taking steps to mitigate or remediate identified threats and vulnerabilities;
  • Implementing processes to guard against and detect malicious software;
  • Training users on malicious software protection; and
  • Implementing access controls.

Ransomware gets into your system, denies you access to your data (usually through encryption), and then directs you to pay a ransom to the hacker in order to receive a decryption key. For this reason, maintaining frequent backups and ensuring the ability to recover data from backups is crucial to surviving a ransomware attack. HIPAA compliance helps protect entities because the Security Rule requires covered entities and business associates to implement a data backup plan as part of an overall contingency plan, which includes periodic testing of the plan to be sure it works.

The presence of ransomware – or any malware – is considered a security incident and triggers the need to initiate security incident response and reporting procedures. Based upon an analysis of the investigation results, breach notification may be required. Additionally, if there is an impermissible disclosure of protected health information (“PHI”) in violation of the privacy rule, there is a presumed breach which may trigger notification. Whether or not the presence of ransomware would be a breach under HIPAA Rules is thus fact specific. However, unless the entity demonstrates there is a “…low probability that the PHI has been compromised,” a breach of PHI is presumed to have occurred and the entity must comply with the applicable breach notification provisions.

Further information and a copy of the OCR report can be found here.

‘The Dark Overlord’ Places Healthcare Databases on Dark Web

Once again news reports teach us that the time to have your robust data privacy and security program in place and continually monitored was yesterday!

On June 26 it was reported on DataBreaches.net that 655,000 patient records from three different healthcare databases were up for sale on the dark net. According to reports on the DeepDotWeb, at least one of the hacked entities was using SRS EHR v.9 patient management software. DeepDotWeb also reports that the hacker communicated with them over an encrypted Jabber conversation, and included images from the largest database hack from the hacker’s internal network. The seller/hacker asked the website to add a note to the breached companies: “Next time an adversary comes to you and offers you an opportunity to cover this up and make it go away for a small fee to prevent the leak, take the offer. There is a lot more to come.”

Apparently it was shortly after that a fourth stolen database consisting of a reported 9.3 million individuals records from a health insurer went up for sale. The hacker taking credit for all refers to himself as “The Dark Overlord”. He claims to have contacted the entities to warn them about the vulnerabilities of their systems, and offered to fix or reveal the problems, for an undisclosed amount, which the healthcare organizations declined. In other words, the hacker offered the stolen data back to its owners for an extorted ransom. When the demand was not paid the hacker moved on to Plan B – sell the data on the dark web. The hacker offered the data from the four hacked healthcare organizations for prices ranging from $96,000 to $490,000 in bitcoin.

In the past week two of The Dark Overlord’s targets – Athens Orthopedic Clinic in Georgia and a Missouri group of clinics owned by Dr. Scott Van Ness – have been identified. The hacker accessed electronic medical records of both targets using the credentials of a third-party vendor. Personal information of current and former patients was breached, including names, addresses, social security numbers, dates of birth and telephone numbers, and in some cases diagnoses and partial medical history. Athens Orthopedic Clinic is advising its current and past patients to place a fraud alert on their credit reports with the major credit bureaus. This notice, however,  is alleged to have materialized only after events of last weekend, when 500 patients records from Athens Orthopedic Clinic appeared on Pastebin, with a note to their CEO to “pay the [expletive omitted] up.”

Notably, according to reports on Databreaches.net, both entities have acknowledged that the attacker likely got access by an unnamed third party contractor (presumably the EMR vendor). Databreaches.net claims however that neither entity mentioned the ransom demands or that patient data was being dumped in public and was still up for sale on the dark net. Athens Orthopedic Clinic apparently did work to get the information removed from Pastebin, but the other group’s data was still posted as of July 16.

Several lessons- or at least questions- must be in the minds of any healthcare organization as they learn of these events. First is to question of whether your own data security is protected from such attacks, or are you vulnerable as well? How safe is your EMR system? How closely do you audit and monitor the third party vendors you contract with? Second, and something I think every organization should have at least a working framework to use for analysis in the event they find themselves the recipient of a post-breach ransom demand, is, what will your response be in the event you receive such a demand?

California Supreme Court Denies Petition for Review in $4 Billion Sutter Health Data Breach Cases

With the California Supreme Court denying a petition for review in Sutter Health v. Superior Court (Atkins), in California a health care provider is not liable for the nominal damages set forth in the state’s Confidentiality of Medical Information Act (CMIA) when password-protected but unencrypted information is stored on a computer and the device is stolen, absent evidence the data was actually viewed.

After the California Court of Appeal, Third Appellate District, dismissed 13 coordinated lawsuits, the plaintiffs’ attorneys in the data theft action filed their petition for review with the California Supreme Court on August 29, 2014.  The plaintiffs claimed whether the data was viewed, Sutter had a duty to protect the confidential information, such as through encryption, and failed to meet its duty.  On October 15, 2014, the court denied the petition.

PVCY BLOG_medical recordsSutter Health maintained medical records concerning the plaintiffs on a desktop computer that was stolen from an office after someone broke in. The medical records of more than 4 million patients were stored on the computer’s hard drive in password-protected but unencrypted format.  The plaintiffs did not allege that any unauthorized persons had actually viewed the records, but claimed potential misuses of the information may not manifest for years.  The plaintiffs sought the $1,000 nominal damages set forth in the CMIA for each class member, or roughly $4.24 billion in damages.

In their complaint, the plaintiffs alleged Sutter Health violated two different sections of the CMIA (§§ 56.10 and 56.101), which invoked the remedy provision of §56.36.  The plaintiffs first argued there was a prohibited unconsented-to disclosure, but the court responded that the statute required an affirmative act of disclosure by the defendant, which was not satisfied by a theft.  The second provision argued provides, “Every provider of health care … who creates, maintains, preserves, stores, abandons, destroys or disposes of medical information shall do so in a manner that preserves the confidentiality of the information contained therein. Any provider … who negligently maintains … [or] stores … medical information shall be subject to the remedies and penalties provided under … Section 56.36.”  That section allows anyone whose confidential information has been negligently released to bring an action for $1,000 nominal damages. “In order to recover under this paragraph it shall not be necessary that the plaintiff suffered or was threatened with actual damages.”

The appellate court held there was no breach of confidentiality absent actual viewing of the information; mere possession of medical information or records by unauthorized persons was insufficient to establish breach of confidentiality. The court agreed with, in part, but differentiated its ruling from Regents of University of California v. Superior Court (2013) 220 Cal.App.4th 549, stating it agrees what is required is pleading and proving the confidential nature of the information was breached as a result of the health care provider’s negligence, but the court arrived at its conclusion differently than Regents.  In Sutter, the court found that without an actual confidentiality breach, a health care provider has not violated § 56.101 and therefore does not invoke the remedy provided in § 56.36. In Regents, the provider did not dispute the allegation it violated § 56.101, and the court’s decision was based on § 56.36.

The case is good news for health care providers, making it clear that a breach under § 56.101 means a breach in the protection of what is being held in confidence – the actual health information. A change of possession of the vehicle holding the confidence does not trigger liability.  Under Sutter, a health care provider is not subject to liability just because possession of a record or computer is lost. There must be an actual breach of the confidential information – that is, confidential information must be accessed.