Healthcare Data Privacy

2019 Data Breach Barometer Report Shows Massive Increase in Exposed Healthcare Records

Protenus has released its 2019 Breach Barometer report: An analysis of healthcare data breaches reported in 2018.

The data for the report came from Databreaches.net, which tracks data breaches reported in the media as well as breach notifications sent to the Department of Health and Human Services’ Office for Civil Rights and state attorneys general.

The report shows there was a small annual increase in the number of healthcare data breaches but a tripling of the number of healthcare records exposed in data breaches.

According to the report, there were 503 healthcare data breaches reported in 2018, up from 477 in 2017. 2017 was a relatively good year in terms of the number of healthcare records exposed – 5,579,438 – but the number rose to 15,085,302 exposed healthcare records in 2018.

In 2017, March was the worst month of the year in terms of the number of records exposed and there was a general downward trend in exposed records throughout the rest of the year. In 2018, there was a general increase in exposed records as the year progressed. The number of exposed records increased each quarter, from 1,175,804 records in Q1 to 6,281,470 healthcare records in Q4.

The largest data breach of the year was a hacking incident at a business associate of a North Carolina health system. Over the space of a week, the hackers gained access to the health records of 2.65 million individuals.

Healthcare hacking incidents have increased steadily since 2016 and were the biggest cause of breaches in 2018, accounting for 44.22% of all tracked data breaches. There were 222 hacking incidents in 2018 compared to 178 in 2017. Data was only available for 180 of those breaches, which combined, resulted in the theft/exposure of 11,335,514 patient records. The hacking-related breaches in 2017 resulted in the theft/exposure of 3,436,742 records. While it was not possible to categorize many of the hacking incidents due to a lack of data, phishing attacks and ransomware/malware incidents were both common.

Insiders were behind 28.09% of breaches, loss/theft incidents accounted for 14.34%, and the cause of 13.35% of breaches was unknown.

Insider breaches included human error and insider wrongdoing. These breaches accounted for a lower percentage of the total than in 2017 when 37% of breaches were attributed to insiders. Information was available for 106 insider-related breaches in 2018. 2,793,607 records were exposed in those breaches – 19% of exposed records for the year. While the total number of insider incidents fell from 176 to 139 year over year, there was a significant increase in the number of records exposed in insider breaches in 2018.

Insider errors resulted in the exposure of 785,281 records in 2017 and 2,056,138 records in 2018. Insider wrongdoing incidents resulted in the exposure of 893,978 records in 2017 and 386,469 records in 2018.

Without the proper tools in place, insider breaches can be difficult to detect. In one case, it took a healthcare provider 15 years to discover that an employee was snooping on patient records. Several incidents took over four years to discover.

Snooping by family members was the most common cause of insider breaches, accounting for 67.38% of the total. Snooping co-workers accounted for 15.81% of insider breaches. Protenus notes that there is a high chance of repeat insider offenses. 51% of cases involved repeat offenders.

Overall, it took an average of 255 days for a breach of any type to be discovered and an average of 73 days for breaches to be reported after they were discovered.

Healthcare providers were the worst affected group with 353 data breaches – 70% of all reporting entities. 62 breaches were reported by health plans (12%) and 39 (8%) were reported by other entities. It was a particularly bad year for business associates of HIPAA covered entities with 49 incidents (10%) reported by business associates. A further 102 incidents (20%) had some business associate involvement.

Protenus expects to trend of more than 1 breach per day to continue in 2019, as has been the case every year since 2016.

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OCR Settles Cottage Health HIPAA Violation Case for $3 Million

The Department of Health and Human Services’ Office for Civil Rights (OCR) has agreed to settle a HIPAA violation case with the Santa Barbara, CA-based healthcare provider Cottage Health for $3,000,000.

Cottage Health operates four hospitals in California – Santa Barbara Cottage Hospital, Santa Ynez Cottage Hospital, Goleta Valley Cottage Hospital and Cottage Rehabilitation Hospital.

In 2013 and 2015, Cottage Health experienced two security incidents that resulted in the exposure of the electronic protected health information (ePHI) of 62,500 patients.

In 2013, Cottage Health discovered a server containing patients’ ePHI had not been properly secured. Files containing patients’ ePHI could be accessed over the internet without the need for a username or password. Files on the server contained patient names, addresses, dates of birth, diagnoses, conditions, lab test results and other treatment information.

Another server misconfiguration was discovered in 2015. After responding to a troubleshooting ticket, the IT team removed protection on a server which similarly exposed patients’ ePHI over the internet. Patient names, addresses, dates of birth, social security numbers, diagnoses, conditions, and other treatment information could all be accessed without a username or password.

OCR investigated the breaches and Cottage Health’s HIPAA compliance efforts. OCR determined that Cottage Health had failed to conduct a comprehensive, organization-wide risk analysis to determine risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI, as required by 45 C.F.R. § 164.308(a)(l)(ii)(A).

Risks and vulnerabilities had not been reduced to a reasonable and acceptable level, as required by 45 C.F.R. § 164.308(a)(l )(ii)(B).

Periodic technical and non-technical evaluations following environmental or operational changes had not been conducted, which violated 45 C.F.R. § 164.308(a)(8).

OCR also discovered Cottage Health had not entered into a HIPAA-complaint business associate agreement (BAA) with a contractor that maintained ePHI: A violation of 45 C.F.R. § 164.308(b) and 164.502(e).

In addition to the financial penalty, Cottage Health has agreed to adopt a 3-year Corrective Action Plan (CAP). The CAP requires Cottage Health to conduct a comprehensive, organization-wide risk analysis to determine all risks to the confidentiality, integrity, and availability of ePHI. Cottage Health must also develop and implement a risk management plan to address all security risks and vulnerabilities identified during the risk analysis. The risk analysis must be reviewed annually and following any environmental or operational changes. A process for evaluating environmental or operational changes must also be implemented.

Cottage Health must also develop, implement, and distribute written policies and procedures covering the HIPAA Privacy and Security Rules and must train all staff on the new policies and procedures. Cottage Health must also report to OCR annually on the status of its CAP for the following three years.

“Our record year underscores the need for covered entities to be proactive about data security if they want to avoid being on the wrong end of an enforcement action,” said OCR Director Roger Severino. “The Cottage settlement reminds us that information security is a dynamic process and the risks to ePHI may arise before, during, and after implementation covered entity makes system changes.”

A Record Year for HIPAA Fines and Settlements

It has been a busy year of HIPAA enforcement for OCR. In 2018, 10 settlements have been agreed with HIPAA-covered entities and business associates in response to violations of HIPAA Rules and one civil monetary penalty has been issued. The 11 financial penalties totaled $28,683,400, which exceeded the previous record of $23,505,300 set in 2016 by 22%.

2018 also saw OCR agree the largest ever HIPAA settlement in history. Anthem Inc., settled alleged violations of HIPAA Rules for $16,000,000. The settlement was almost three times larger than the previous record – The $5.5 million settlement with Advocate Health Care Network in 2016.

Further Information: 2018 HIPAA Fines and Settlements

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Wyoming Considers Repealing Hospital Records Act

Wyoming is considering repealing the Hospital Records Act of 1991, an act that was introduced to ensure the privacy of patient information was protected. The law was enacted before the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and provided protections that did not previously exist at the state or federal level.

The Hospital Records Act introduced similar protections for patients those provided by HIPAA. The Act covered disclosures of patient information by hospitals, authorizations from patients prior to disclosure of patient information, the publishing notices of privacy practices, the persons authorized to act on behalf of patients, and security safeguards and rules covering record retention.

The Hospital Records Act was effective at the time but following the enactment of HIPAA and its subsequent Privacy and Security Rules, it became redundant.

While the requirements of both the federal and state laws are similar, there are several discrepancies between the two laws and the compliance requirements differ slightly.

The Hospital Records Act is seen to be creating unnecessary regulatory hurdles for hospitals as well as causing some issues for law enforcement. For some hospitals, the complications of having to comply with both sets of regulations could place them at risk of fines for non-compliance with HIPAA.

The Wyoming law is also primary focused on hospitals. Hospitals are required to comply with both laws, while physician’s offices are only required to comply with HIPAA. Repealing the law would make compliance uniform for all healthcare organizations.

Sen. Dave Kinskey (R-Sheridan); Rep. Mark Kinner (R-Sheridan); and Rep. Cyrus Western (R-Big Horn) have sponsored the bill (Senate File 96 SF0096). If enacted, Wyoming would hospital records and information statutes repealed, and the state would rely on the protections demanded by HIPAA. Hospitals would benefit from greater clarity over privacy and security requirements without reducing patient privacy protections.

The bill was introduced in the House on January 29, 2019 after passing three readings in the state Senate.

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Legal Action Over Illinois Biometric Information Privacy Act Violations Possible Without Actual Harm

The Illinois Supreme Court has ruled that individuals whose privacy has been violated through a breach of the Illinois Biometric Information Privacy Act can take legal action against a private entity, even if the violation of BIPA has not resulted in actual harm.

The Illinois Biometric Information Privacy Act, enacted in 2008, requires private entities to inform a person in writing that their biometric information will be collected or stored. The purpose for the collection or storage of that data and the length of time the information will be retained must also be explained. The entity must also obtain written authorization from an individual or that individual’s legal representative before biometric data can be collected or stored.

Biometric data includes fingerprints, voiceprints, hand scans, iris scans, and other biometric means of identifying a person.

In contrast to HIPAA, which has no private cause of action, individuals can sue companies for Illinois Biometric Information Privacy Act (BIPA) violations. Illinois is unique in that respect. Other states such as Texas and Washington have similar laws, but in those states, there is no private cause of action. Further, according to a ruling by the Illinois Supreme Court on January 25, 2019, legal action can be taken without an allegation of actual injury or an adverse event as a result of the violation.

Plaintiff Stacy Rosenbach took legal action against Six Flags Entertainment Corp., following a visit to a Six Flags amusement park by her 14-year-old son. He was required to provide his fingerprint to access the amusement park. Nether Stacy Rosenbach nor her son were informed in writing about the reason for collecting her son’s fingerprint or the length of time it would be stored. Written authorization to collect the fingerprint was also not obtained by Six Flags.

The plaintiff did not allege harm in the case, which was filed solely over the violation of BIPA. Six Flags sought to have the case dismissed for lack of standing as the plaintiff had not suffered actual harm or threatened injury. The circuit court denied the motion to dismiss, that decision was reversed by the court of appeal, and the Supreme Court reversed the court of appeal’s decision.

The court’s held that a technical violation of BIPA is, in itself, sufficient to support an individual’s statutory cause of action. No proof of an actual injury or damage as a result of the BIPA violation is required and consumer’s need not wait until they have suffered harm as a result of the violation to take legal action.

If it can be established and proven that a violation of BIPA has occurred due to negligence, individuals could receive up to $1,000 for each violation. In cases of reckless or intentional violations of BIPA, up to $5,000 could be received per violation.

According to the ruling, ensuring compliance with BIPA is not difficult and the costs of compliance are likely to be insignificant compared to the substantial and irreversible harm that could be caused to consumers if their biometric identifiers are not appropriately safeguarded and kept private and confidential.

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Aetna Settles HIV Status Breach Case with California AG for $935,000

Hartford, CT-based health insurer Aetna has agreed to pay the California Attorney General $935,000 to resolve alleged violations of state laws related to a 2017 privacy violation that exposed state residents’ HIV status.

On July 28, 2017, Aetna’s mailing vendor sent letters to plan members who were receiving HIV medications or pre-exposure prophylaxis to prevent them from contracting HIV. The letters contained instructions for their HIV medications; however, information about the HIV medications was clearly visible through the window of the envelopes, resulting in the impermissible disclosure of highly sensitive information to postal workers, friends, family members, and roommates.  Approximately 12,000 individuals were sent letter, 1,991 of whom lived in California.

The privacy breach was a violation of HIPAA Rules, and according to California Attorney General Xavier Becerra, also a violation of several California laws including the Unfair Competition Law, the Confidentiality of Medical Information Act, the Health and Safety Code (section 120980), and the State Constitution.

In addition to the financial penalty, the settlement agreement requires Aetna to designate an employee to implement and maintain its mailing program, oversee compliance with state and federal laws, and the management of external vendors to ensure they handle medical data in compliance with state and federal laws and Aetna’s policies and procedures. Aetna is also required to complete an annual privacy risk assessment to evaluate compliance with the terms of the settlement for the next three years.

“A person’s HIV status is incredibly sensitive information and protecting that information must be a top priority for the entire healthcare industry,” said Attorney General Bercerra. “Aetna violated the public’s trust by revealing patients’ private and personal medical information.”

The privacy violation has proven expensive for Aetna. In January 2018, Aetna settled a class action lawsuit filed on behalf of victims of the breach for $17,161,200. Also in January, Aetna agreed to pay the New York Attorney General $1,150,000 to settle its case and resolve alleged HIPAA violations and breaches of state law.

A further $640,170.59 was paid to settle a multi-state action by Attorneys General in New Jersey, Connecticut, Washington, and the District of Columbia. The latest settlement brings the total financial penalties issued to date in relation to the breach to $2,725,170.59.

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Oregon Health Information Property Act Proposes Paying Patients to Share Their Healthcare Data

The Oregon Health Information Property Act proposes patients should be allowed to give authorization to their healthcare providers to sell on their health data and to receive payment in exchange for allowing their data to be used by third parties.

Currently, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule limits the allowable uses and disclosures of ‘Protected Health Information.’ HIPAA-covered entities are only permitted to use or disclose PHI for purposes related to the provision of treatment, payment for healthcare, or healthcare operations. While there are some exceptions, other uses and disclosures are prohibited unless consent is first obtained from patients.

The HIPAA Privacy Rule covers PHI, which is identifiable patient information. If PHI is stripped of information that allow an individual to be identified, it is no longer considered PHI and is no longer subject to Privacy Rule controls. That means that if a HIPAA-covered entity de-identifies PHI, they can then sell that information on for profit. That information can be valuable to research organizations and other entities.

Senate Bill 703, dubbed the Oregon Health Information Property Act, is sponsored by Senator Floyd Prozanski (D-Eugene) and has the support of than 40 co-sponsors. Essentially, the bill would see consumers health information treated in a similar way to property and would allow them to profit from its sale.

The Oregon Health Information Property Act

The Oregon Health Information Property Act has three main components:

  1. It would require HIPAA-covered entities and their business associates and subcontractors to obtain a signed authorization from consumers before they de-identify PHI to sell on to third parties.
  2. Consumers could choose if they want to receive payment in exchange for giving authorization to allow their health data to be sold.
  3. The bill also prevents consumers from being discriminated against for refusing to sign an authorization or choosing to receive payment.

HIPAA-covered entities are able to profit from selling de-identified data so it is argued that patients should receive a cut of the payment; however, despite having attracted considerable support, concern has been voiced about the impact of these authorizations.

The bill, in its current form, does not place any limitations on the uses of health data once authorization has been provided. Information could therefore be used for a wide range of purposes once authorization has been given – Reasons that may not necessarily be listed on the authorization form.

The bill also makes no distinction between an individual’s protected health information, health information or de-identified data. By signing a form to receive a small payment, consumers would be relinquishing their privacy and important protections afforded by HIPAA, which could have various unintended repercussions.

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New Cybersecurity Framework for Medical Devices Issued by HSCC

The Healthcare and Public Health Sector Coordinating Council (HSCC) has issued a new cybersecurity framework for medical devices. Medical device vendors, healthcare providers, and other healthcare industry stakeholders that adopt the voluntary framework will be able to improve the security of medical devices throughout their lifecycle.

The HSCC is a coalition of private sector critical healthcare infrastructure entities that have partnered with the government to identify and mitigate threats and vulnerabilities facing the healthcare sector. The group comprises more than 200 healthcare industry and government organizations. Together they work on developing strategies to address current and emerging cybersecurity challenges faced by the healthcare sector.

More than 80 organizations contributed to the development of the Medical Device and Health IT Joint Security Plan (JSP), which builds on recommendations made by the Healthcare Industry Cybersecurity Task Force established by the Department of Health and Human Services following the passing of the Cybersecurity Information Sharing Act of 2015.

“It is important for medical device manufacturers and health IT vendors to consider the JSP’s voluntary framework and its associated plans and templates throughout the lifecycle of medical devices and health IT because doing so is expected to result in better security and thus better products for patients,” explained HSCC.

Cybersecurity controls can be difficult to integrate into existing processes. Organizations often fail to recognize how important security controls are, and when considering how to enhance cybersecurity many do not know where to start or have insufficient resources to devote to the task. The framework helps by providing guidance on how to create a security policy and procedures that align with and integrate into existing processes.

HSCC is urging organizations to commit to implementing the JSP as it is believed that by doing so patient safety will be improved.

The JSP can be adopted by organizations of all sizes and stages of maturity and helps them enhance cybersecurity of medical devices by addressing key challenges. Many large manufacturers have already created similar cybersecurity programs to the JSP, so it is likely to be of most use for small to medium sized companies that lack awareness of the steps to take to improve cybersecurity as well as those with fewer resources to devote to cybersecurity.

The JSP utilizes security by design principles and identifies shared responsibilities between industry stakeholders to harmonize security standards, risk assessment methodologies, reporting of vulnerabilities, and improve information sharing between device manufacturers and healthcare providers. The JSP covers the entire lifecycle of medical devices, from development to deployment, management, and end of life. The JSP includes several recommendations including the incorporation of cybersecurity measures during the design and development of medical devices, handling product complaints related to cybersecurity incidents, mitigation of post-market vulnerabilities, managing security risk, and decommissioning devices at end of life.

The Medical Device and Health IT Joint Security Plan can be downloaded on this link.

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Patches Released to Mitigate Stryker Medical Bed KRACK Vulnerabilities

Nine vulnerabilities have been identified in Stryker Medical Beds. The vulnerabilities could be exploited in a man-in-the-middle attack by an attacker within radio range of vulnerable product to replay, decrypt, or spoof frames.

The vulnerabilities are present in the four-way handshake used by WPA and WPA2 wireless security protocols which allow nonce reuse in Key Reinstallation (KRACK) attacks. Similar vulnerabilities have been identified in a wide range of wireless devices.

The nine vulnerabilities are summarized below:

  • CVE-2017-13077: Reinstallation of pairwise key in the four-way handshake.
  • CVE-2017-13078: Reinstallation of group key in the four-way handshake.
  • CVE-2017-13079: Reinstallation of Integrity Group Temporal Key in the four-way handshake.
  • CVE-2017-13080: Reinstallation of group key in the group key handshake.
  • CVE-2017-13081: Reinstallation of Integrity Group Temporal Key in the group key handshake.
  • CVE-2017-13082: Reinstallation of Pairwise Transient Key Temporal Key in the fast BSS transmission handshake.
  • CVE-2017-13086: Reinstallation of Tunneled Direct-Link Setup Peer Key in the Tunneled Direct-Link Setup handshake.
  • CVE-2017-13087: Reinstallation of the Group Temporal Key when processing a Wireless Network Management Sleep Mode Response frame.
  • CVE-2017-13088: Reinstallation of the Integrity Group Temporal Key when processing a Wireless Network Management Sleep Mode Response frame.

The group of vulnerabilities have collectively been assigned a CVSS v3 base score of 6.8 – Medium severity. The flaws were identified by Mathy Vanhoef of imec-DistriNet, KU Leuven and reported to the National Cybersecurity & Communications Integration Center (NCCIC).

Mitigations

Software updates have been released by Stryker to mitigate the vulnerabilities:

  • Users of Gateway 2.0 should upgrade to software version 5212-400-905_3.5.002.01
  • Users of Gateway 3.0 should upgrade to software version 5212-500-905_4.3.001.01

No patch is available for Gateway 1.0.

Additional measures can also be taken to reduce the risk of exploitation of the vulnerabilities. These include disabling iBed functionality if it is not being used, operating the products on a separate VLAN, and applying updates that include the KRACK patch to wireless access points.

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GDPR Incorporated into the HITRUST CSF

HITRUST has combined the European Union’s General Data Protection Regulation (GDPR) into the HITRUST Cybersecurity Framework (HITRUST HSF) and is working toward the creation of a single framework and assessment covering all regulatory requirements.

Many countries have introduced new data privacy and security regulations that require companies to implement new policies, procedures, and technologies to keep consumers’ and customers’ data private and confidential. Organizations that wish to conduct business globally must ensure they comply with these country-specific regulations and should conduct assessments to make sure they are fully compliant. The penalties for violations of these regulations can be considerable. GDPR violations can attract a fine up to 4% of global annual turnover, or €20 million, whichever is greater.

Meeting complex compliance requirements and assessing compliance efforts can be a major challenge, although HITRUST’s “one framework, one assessment” model makes the process as simple as possible.

“As countries around the world continue to adopt and advance data protection laws, the challenge of doing business on a global scale grows increasingly complex,” said HITRUST chief privacy officer, Anne Kimbol. “Many countries have their own unique regulatory requirements, creating costs and challenges for organizations to determine if they are compliant to conduct business globally.”

HITRUST has completed the formal application process to the Irish Data Protection Commission and the EU Data Protection Board to have the HITRUST CSF officially recognized as meeting GDPR certification standards and hopes to be confirmed as an accredited certification body for GDPR.

In addition to GDPR, HITRUST has incorporated the Singapore Personal Data Protection Act (PDPA) into the HITRUST HSF and is currently working toward becoming an Accountability Agent under Asia-Pacific Economic Cooperation (APEC) Cross Border Privacy Rules and Procedures for Processing programs.

“Businesses leveraging the HITRUST Approach will be able to leverage a single HITRUST CSF Assessment to report their security, privacy and compliance posture to various audiences globally,” explained HITRUST VP of standards and analysis, Bryan Cline.

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