HIPAA Compliance News

$3.5 Million Settlement to Resolve HIPAA Violations That Contributed to Five Data Breaches

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The first HIPAA settlement of 2018 has been announced by the Department of Health and Human Services’ Office for Civil Rights (OCR). Fresenius Medical Care North America (FMCNA) has agreed to pay OCR $3.5 million to resolve multiple potential HIPAA violations that contributed to five separate data breaches in 2012.

The breaches were experienced at five separate covered entities, each of which was owned by FMCNA. Those breached entities were:

  • Bio-Medical Applications of Florida, Inc. d/b/a Fresenius Medical Care Duval Facility in Jacksonville, Florida (FMC Duval)
  • Bio-Medical Applications of Alabama, Inc. d/b/a Fresenius Medical Care Magnolia Grove in Semmes, Alabama (FMC Magnolia Grove)
  • Renal Dimensions, LLC d/b/a Fresenius Medical Care Ak-Chin in Maricopa, Arizona (FMC Ak-Chin)
  • Fresenius Vascular Care Augusta, LLC (FVC Augusta)
  • WSKC Dialysis Services, Inc. d/b/a Fresenius Medical Care Blue Island Dialysis (FMC Blue Island)

Breaches Experienced by FMCNA HIPAA Covered Entities

The five security breaches were experienced by the FMCNA covered entities over a period of four months between February 23, 2012 and July 18, 2012:

  • The theft of two desktop computers from FMC Duval during a February 23, 2012 break-in. The computers contained the ePHI – including Social Security numbers – of 200 individuals
  • The theft of an unencrypted USB drive from FMC Magnolia Grove on April 3, 2012. The device contained the PHI – including insurance account numbers – of 245 individuals
  • On April 6, 2012 FMC Ak-Chin discovered a hard drive was missing. The hard drive had been removed from a computer that had been taken out of service and the drive could not be located. The hard drive contained the PHI – including Social Security numbers – of 35 individuals
  • An unencrypted laptop computer containing the ePHI of 10 patients – including insurance details – was stolen from the vehicle of an employee on June 16, 2012. The laptop had been left in the vehicle overnight. The bag containing the laptop also contained the employee’s list of passwords
  • Three desktop computers and one encrypted laptop were stolen from FMC Blue Island on or around June 17-18, 2012. One of the computers contained the PHI – including Social Security numbers – of 35 patients

Multiple HIPAA Failures Identified

OCR launched an investigation into the breaches to establish whether they were the result of failures to comply with HIPAA Rules. The investigation revealed a catalogue of HIPAA failures.

OCR established that the FMCNA covered entities had failed to conduct a comprehensive and accurate risk analysis to identify all potential risks to the confidentiality, integrity, and availability of ePHI: One of the most common areas of non-compliance with HIPAA Rules. If an accurate risk assessment is not performed, risks are likely to be missed and will therefore not be managed and reduced to an acceptable level.

OCR also discovered the FMCNA covered entities had impermissibly disclosed the ePHI of many of its patients by providing access to PHI that is prohibited under the HIPAA Privacy Rule.

Several other potential HIPAA violations were discovered at some of the FMCNA covered entities.

FMC Magnolia Grove did not implement policies and procedures governing the receipt and removal of computer hardware and electronic storage devices containing ePHI from its facility, and neither the movement of those devices within its facility.

FMC Magnolia Grove and FVC Augusta had not implemented encryption, or an equivalent, alternative control in its place, when such a measure was reasonable and appropriate given the risk of exposure of ePHI.

FMC Duval and FMC Blue were discovered not to have sufficiently safeguarded their facilities and computers, which could potentially lead to unauthorized access, tampering, or theft of equipment.

FMC Ak-Chin had no policies and procedures in place to address security breaches.

Financial Penalty Reflects the Seriousness and Extent of HIPAA Violations

The $3.5 million settlement is one of the largest issued to date by OCR to resolve violations of HIPAA Rules. In addition to paying the sizeable financial penalty, FMCNA has agreed to adopt a robust corrective actin plan to address all HIPAA failures and bring its policies and procedures up to the standard demanded by HIPAA.

The FMCNA covered entities must conduct comprehensive, organization wide risk analyses to identify all risks to the confidentiality, integrity, and availability of PHI and develop a risk management plan to address all identified risks and reduce them to a reasonable and acceptable level.

Policies and procedures must also be developed and implemented covering device, media, and access controls and all staff must receive training on current and new HIPAA policies and procedures.

“The number of breaches, involving a variety of locations and vulnerabilities, highlights why there is no substitute for an enterprise-wide risk analysis for a covered entity,” said OCR Director Roger Severino. “Covered entities must take a thorough look at their internal policies and procedures to ensure they are protecting their patients’ health information in accordance with the law.”

Settlement Shows it is Not the Size of the Breach that Matters

All of the five breaches resulted in the exposure of relatively few patients’ PHI. No breach involved more than 235 records, and three of the breaches exposed fewer than 50 records.

The settlement shows that while the scale of the breach is considered when deciding on an appropriate financial penalty, it is the severity and the extent of non-compliance that is likely to see financial penalties pursued.

The settlement also clearly shows that OCR does investigate smaller breaches and will do so when breaches suggest HIPAA Rules have been violated.

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Aetna Agrees to Pay $115 Million Settlement to Resolve NY Attorney General Data Breach Case

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Last July, Aetna sent a mailing to members in which details of HIV medications were clearly visible through the plastic windows of envelopes, inadvertently disclosing highly sensitive HIV information to individuals’ house mates, friends, families, and loved ones.

Two months later, a similar privacy breach occurred. This time the mailing related to a research study regarding atrial fibrillation (AFib) in which the term IMACT-AFIB was visible through the window of the envelope. Anyone who saw the envelope could have deduced the intended recipient had an AFib diagnosis.

The July breach triggered a class action lawsuit which was recently settled by Aetna for $17.2 million. Aetna must now also cover a $115 million settlement with the New York Attorney General to resolve violations of federal and state laws.

Attorney General Schneiderman launched an investigation following the breach of HIV information in July, which violated the privacy of 2,460 Aetna members in New York. The September privacy breach was discovered during the course of that investigation. 163 New York Aetna members had their privacy violated by the September mailing.

The settlement agreement explains that more than 90% of patients diagnosed with HIV face discrimination and prejudice, and approximately one in eight individuals with HIV are denied health services as a result of the stigma associated with HIV and AIDS. A breach of HIV information can therefore have severe repercussions for the victims.

New York has implemented strict laws that require HIV information to be kept secure and confidential to ensure its residents are not discouraged from coming forward to be tested and treated for HIV. It is therefore important that action is taken against organizations and individuals who violate state laws by disclosing HIV information.

As a HIPAA-covered entity, Aetna is bound by the regulations and is required to implement safeguards to ensure the confidentiality of health and HIV information. Several laws in New York also require safeguards to be implemented to protect personal health information and personally identifiable information.

Not only were state and federal laws violated by the mailing, Aetna provided the personal health information of its members to outside counsel who in turn gave that information to a settlement administrator. While the outside counsel was a business associate of Aetna and had signed a business associate agreement, its subcontractor, the settlement administrator, was also a business associate yet no business associate agreement was entered into prior to the disclosure of PHI. A further violation of HIPAA Rules.

The office of the attorney general determined Aetna’s two mailings violated 45 C.F.R § 164.502; 42 U.S.C. § 1320d-5 of HIPAA, N.Y General Business Law § 349, N.Y Public Health Law § 18(6), and N.Y Executive Law § 63(12).

The settlement agreement also draws attention to the fact that Aetna had reported a further three HIPAA breaches to the Office for Civil Rights in the past 24 months, which in total impacted more than 25,000 individuals.

In addition to the financial penalty, Aetna has agreed to update its policies, procedures and controls to enhance the privacy protections for its members and protect them from negligent disclosures of personal health information and personally identifiable information through its mailings.

“Through its own carelessness, Aetna blatantly violated its promise to safeguard members’ private health information,” said Attorney General Eric T. Schneiderman. “Health insurance companies handle personal health information on a daily basis and have a fundamental responsibility to be vigilant in protecting their members. We won’t hesitate to act to ensure that insurance companies live up to their responsibilities to the New Yorkers they serve.”

This may not be the last financial penalty Aetna has to cover in relation to the mailings. This $115 million settlement only resolves the privacy violations of 2,460 Aetna members in New York state. The mailing was sent to around 13,000 Aetna members across the United States. It is possible that other states will similarly take action over the privacy violations. The Department of Health and Human Services’ Office for Civil Rights is also investigating the data breach and may choose to penalize the insurer for violating HIPAA Rules.

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Kansas Attorney General Fines Healthcare Provider for Failing to Protect Patient Records

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The Topeka, KS-based healthcare company Pearlie Mae’s Compassion and Care LLC and its owners have been fined by the Kansas Attorney General for failing to protect patient and employee records. The healthcare provider has agreed to pay a civil monetary of $8,750.

The HITECH Act gave attorneys general the authority to enforce HIPAA rules and take action against HIPAA-covered entities and business associates that are discovered not to be in compliance with HIPAA regulations. Only a handful of state attorneys general have exercised those rights, with many opting to pursue privacy violations under state laws.

In this case, Attorney General Derek Schmidt issued the civil monetary penalty for violations of the Wayne Owen Act, which is part of the Kansas Consumer Protection Act.

Special agents of the Kansas attorney general’s office were assisting the Topeka Police Department execute a search warrant in June 2017 at the home of Ann Marie Kaiser, one of the owners of Pearlie Mae’s Compassion and Care. Kaiser’s home was used as an office location for the company. While at the property, the agents noticed unsecured medical records in open view.

The paperwork included personal information, which includes, social security numbers, driver’s license numbers, financial account numbers, which could be used to harm the persons whose information is compromised. Such information could have been viewed by anyone in the property, including individuals unauthorized to access the information.

The civil penalty was issued for the failure to maintain reasonable procedures and practices appropriate to the nature of information held, the failure to exercise reasonable care to protect personal information, and the failure to take reasonable steps to destroy records when they were no longer required – violations of K.S.A. 50-6,139b(b)(l) and K.S.A. 50-6,139b(b)(2).

In addition to covering the financial penalty, Pearlie Mae’s has agreed to update its policies and procedures to ensure compliance with the Wayne Owen Act and will also cover the costs – $1,250 – incurred by the Attorney general office during its investigation.

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Is Google Docs HIPAA Compliant?

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Is Google Docs HIPAA compliant? Is it permitted to upload documents containing protected health information to Google Docs, or would that violate HIPAA Rules? In this post we will assess Google Docs and determine whether Google is a HIPAA compliant and whether it can be used safely and securely by HIPAA-covered entities and business associates for sharing PHI.

Does Google Docs Encrypt Data?

In order for Google Docs to be HIPAA compliant, stored data must be encrypted. Data must also be encrypted during uploading and downloading. We can confirm that Google uses 28-bit or stronger Advanced Encryption Standard (AES) to protect data in transit to the platform, and between and in its data centers.

Is Google Considered a Conduit?

The Department of Health and Human Services has made it clear in recent guidance that cloud service providers are not – in the vast majority of cases – considered conduits, so the HIPAA Conduit Exception Rule does not apply. Instead, cloud service providers are classed as business associates, even if the service provider does not access data stored in customer accounts.

Will Google Sign a BAA for Google Docs?

As a business associate, prior to the use of Google Docs for sharing or storing documents containing PHI, a business associate agreement must be obtained from Google. Many cloud companies offer BAA’s to covered entities, but it is important to check that a particular product is listed as covered by the BAA prior to use.

Google is willing to sign a BAA with G Suite enterprise customers. We have checked the terms of the BAA and Google Docs is specifically mentioned as part of Google Drive, and is covered by its BAA.

Google clearly states that healthcare organizations covered by HIPAA Rules must not use G Suite in connection with PHI until a business associate agreement has been obtained. Once that BAA has been obtained, Google is not liable for misuse of its service. It is the responsibility of the covered entity or business associate using the service to ensure that HIPAA Rules are followed. That means configuring access controls, amendment, and accounting in accordance with HIPAA Rules. Google offers a useful guide for HIPAA covered entities to help them configure G Suite correctly.

Is Google Docs HIPAA Compliant?

Our opinion is no software or cloud platform can be called HIPAA compliant. HIPAA compliance depends on how a service is used. That said, it is possible to use Google Docs without violating HIPAA Rules.

Before any documents containing PHI are uploaded to Google Docs, the covered entity or business associate must first obtain a signed business associate agreement from Google. Once that BAA has been obtained, staff that are required to use Google Docs must receive training on its use and should be made aware of the restrictions in place with respect to PHI.

Documents containing PHI must only be uploaded to accounts that are not publicly accessible, and permissions must be set to ensure only authorized individuals can access the documents/account.  Any PHI included in files uploaded to Google Docs must be in the document itself, and not used in the file name.

Provided these precautions are taken, Google Docs is HIPAA compliant.

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Is FaceTime HIPAA Compliant?

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Is FaceTime HIPAA compliant? Can FaceTime be used by HIPAA covered entities to communicate protected health information (PHI) without violating HIPAA Rules?

In this article we will examine the protections in place to keep transmitted information secure, whether Apple will sign a business associate agreement for FaceTime, and if a BAA is necessary.

Will Apple Sign A BAA for FaceTime?

An extensive search of the Apple website has revealed no sign that Apple will sign a business associate agreement with healthcare organizations for any of its services. The only mention of its services in relation to HIPAA-covered entities is in relation to iCloud, which Apple clearly states should not be used by healthcare providers or their business associates to create, receive, maintain or transmit PHI.

Since Apple is not prepared to sign a business associate agreement for FaceTime, that would indicate FaceTime is not a HIPAA compliant service. However, business associate agreements only need to be signed by business associates. So, is Apple a business associate?

The HIPAA Conduit Exception Rule

The HIPAA Conduit Exception Rule applies to organizations that act as conduits through which PHI is sent. The HIPAA Conduit Exception Rule covers entities such as the US Postal Service, some courier companies, and their electronic equivalents. Internet Service Providers (ISPs) fall under the description of “electronic equivalents,” as do telephone service providers such as AT&T. But what about FaceTime?

There is some debate about whether FaceTime is covered by the HIPAA Conduit Exception Rule. In order to be considered as a conduit, the service provider must not store any PHI, must not access PHI, and not have the key to unlock encryption.

The Office for Civil Rights has confirmed on its website that cloud service providers are generally not considered conduits, even if the CSP does not access ePHI, or cannot view the information because ePHI is encrypted and no key is held to unlock the encryption. That is because the HIPAA Conduit Exception Rule only applies to transmission-only services, where any ePHI storage is only transient. That is not the case with CSPs.

Apple has confirmed that all communications through FaceTime are protected by end to end encryption. Access controls are in place, via Apple IDs, to ensure the service can only be used by authorized individuals. Apple also does not store any information sent via FaceTime. FaceTime is a peer-to-peer communication channel, and voice and audio communications are transmitted between the individuals involved in the session. Apple also cannot decrypt sessions.

Apple says, “FaceTime uses Internet Connectivity Establishment (ICE) to establish a peer-to-peer connection between devices. Using Session Initiation Protocol (SIP) messages, the devices verify their identity certificates and establish a shared secret for each session. The cryptographic nonces supplied by each device are combined to salt keys for each of the media channels, which are streamed via Secure Real Time Protocol (SRTP) using AES-256 encryption.”

Is FaceTime HIPAA Compliant?

So, is FaceTime HIPAA compliant? No communications platform can be truly HIPAA compliant as HIPAA compliance is about users, not technology. It would be possible to use FaceTime in a noncompliant way, such as communicating PHI with an individual who is not authorized to have the information. However, protections are in place to ensure FaceTime can be used in a HIPAA compliant fashion.

The question is FaceTime HIPAA compliant depends entirely on whether it is classed as a conduit, since Apple will not sign a BAA. In our opinion, FaceTime could be classed as a conduit. The US Department of Veteran Affairs also believes FaceTime is HIPAA compliant and allows its use, which shows it is confident that the service is classed as a conduit.

However, other companies that provide video conferencing platforms do not feel the same way, and offer to sign BAAs with HIPAA-covered entities. Therefore, our advice is to use one of those business solutions rather than the consumer-focused FaceTime and err on the side of caution.

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The HIPAA Conduit Exception Rule and Transmission of PHI

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The HIPAA Conduit Exception Rule is a source of confusion for many HIPAA covered entities, but it is essential that this aspect of HIPAA is understood. Failure to correctly classify a service provider as a conduit or a business associate could see HIPAA Rules violated and a significant financial penalty issued for noncompliance.

The HIPAA Omnibus Final Rule and Business Associates

On January 25, 2013, the HIPAA Omnibus Final Rule was issued. The HIPAA Omnibus Final Rule introduced a swathe of updates to HIPAA Rules, including the incorporation of the Health Information Technology for Economic and Clinical Health (HITECH) Act.

HIPAA Omnibus Final Rule included an update to the definition of a business associate. Prior to January 25, 2013, a business associate was a person or entity that creates, receives, or transmits protected health information (PHI) on behalf of a covered entity. The Omnibus rule added ‘maintains’ to that definition. That meant companies that store electronic information – or physical records – are considered business associates. The Omnibus Rule also confirmed that most data transmission service providers are also classed as business associates.

What is the HIPAA Conduit Exception Rule?

The HIPAA Conduit Exception Rule is detailed in the HIPAA Privacy Rule, but was defined in the HIPAA Omnibus Final Rule. The Rule allows HIPAA-covered entities to use certain vendors without having to enter into a business associate agreement. The HIPAA Conduit Exception Rule is narrow and excludes an extremely limited group of entities from having to enter into business associate agreements with covered entities. The Rule applies to entities that transmit PHI but do not have access to the transmitted information and do not store copies of data. They simply act as conduits through which PHI flows.

HIPAA Conduit Exception Rule covers organizations such as the US Postal Service and certain other private couriers such as Fed-Ex, UPS, and DHL as well as their electronic equivalents. Companies that simply provide data transmission services, such as internet Service Providers (ISPs), are considered conduits.

The HIPAA Conduit Exception Rule is limited to transmission-only services for PHI. If PHI is stored by a conduit, the storage must be transient in nature, and not persistent.

It does not matter if the service provider says they do not access transmitted information. To be considered a conduit, the service provider must not have access to PHI, must only store transmitted information temporarily, and should not have a key to unlock encrypted data.

Vendors that are often misclassified as conduits are email service providers, fax service providers, cloud service providers, and SMS and messaging service providers. These service providers are NOT considered conduits and all must enter into a business associate agreement with a covered entity prior to the service being used in conjunction with any PHI.

Some service providers claim that they are conduits when they are not, in order to avoid having to sign a business associate agreement. Certain fax service providers have claimed they are conduits, and while they appear at face value to be an electronic equivalent to an organization such as the US Postal Service, they are not covered by the HIPAA Conduit Exception Rule. Fax services do not simply send documents from the sender to the recipient. Faxes are stored, and the storage is not considered transient.

Penalties for Misclassifying a Business Associate as a Conduit

Any vendor that has routine access to PHI is considered a business associate (We have covered the definition of a HIPAA business associate on this page). All business associates must sign a business associate agreement with the HIPAA-covered entity before PHI is provided or access to PHI is granted.

Misclassifying a vendor as a conduit rather than a business associate can result in a significant financial penalty, since PHI will have been disclosed without first entering into a business associate agreement.

The Department of Health and Human Services’ Office for Civil Rights has financially penalized many covered entities that have been discovered to have disclosed PHI to a vendor without obtaining a BAA.

In 2017, the Center for Children’s Digestive Health settled with OCR for $31,000 to resolve business associate agreement failures. In 2016, Care New England Health System settled its HIPAA violation case for $400,000, North Memorial Health Care of Minnesota paid $1,550,000 and Oregon Health & Science University settled for $2,700,000.

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Deadline for Reporting 2017 HIPAA Data Breaches Approaches

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The deadline for reporting 2017 HIPAA data breaches to the Department of Health and Human Services’ Office for Civil Rights is fast approaching.

HIPAA-covered entities have a maximum of 60 days from the discovery of a data breach to report security incidents to OCR and notify affected patients. Smaller breaches of PHI do not need to be reported to OCR within this time frame, instead covered entities can delay reporting those breaches to OCR until the end of the calendar year.

The maximum allowable time for reporting breaches impacting fewer than 500 individuals is 60 days from the end of the year in which the breach was experienced. The final day for reporting 2017 HIPAA data breaches to OCR is therefore March 1, 2018.

A HIPAA data breach is defined as an “acquisition, access, use, or disclosure” of unsecured protected health information (PHI) that is not permitted by the HIPAA Privacy Rule. Unsecured PHI is defined as PHI that is “not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology,” such as encryption. A breach of encrypted PHI is not reportable unless the key to unlock the encryption is also reasonably believed to have also been compromised.

Covered entities should be aware that ransomware incidents are usually reportable HIPAA data breaches, even if PHI has not been stolen in the attack. To avoid reporting a ransomware incident, a covered entity must be able to demonstrate a low probability of PHI being compromised in the attack. That determination must be based on a risk assessment (See 45 CFR § 164.402)

While covered entities can submit details of all ‘small’ PHI breaches at the same time, each breach must be reported as a separate event. They can not all be uploaded to the breach portal together.

While the HIPAA Breach Notification Rule allows covered entities additional time to report data breaches impacting fewer than 500 individuals, notifications for individuals impacted by those data breaches cannot be delayed. They must be issued within 60 days of the discovery of the breach, and without unnecessary delay, regardless how many individuals have been impacted by the breach.

It is a good best practice to report all breaches of PHI within 60 days of discovery. Oftentimes, full information about the breach is not available at the time of reporting, but it is possible to add further information to the OCR data breach reports when further information becomes available. If the number of individuals affected by the breach has not been confirmed, estimates should be provided. The final total can then be submitted to OCR as an update to the breach report when the number of individuals impacting has been determined.

The penalties for the late reporting of data breaches can be severe, and OCR made it clear in January 2017 that ignoring the deadline for reporting breaches, or unnecessarily delaying breach reports, is a HIPAA violation that will not be ignored. Presense Health became the first covered entity to be fined solely for delaying breach notifications and settled the HIPAA violation with OCR for $475,000.

OCR has yet to issue a financial penalty to a covered entity for the late reporting of small data breaches, but since OCR tends to set examples with its breach settlements, 2018 could well see the first penalty issued.

To avoid a HIPAA penalty, ensure all small breaches of PHI are reported to OCR between now and the end of February 2018 and no later than midnight on March 1.

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HHS Sued by CIOX Health Over Unlawful HIPAA Regulations

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The Department of Health and Human Services is being sued by CIOX Health, a medical record retrieval company, over updates to HIPAA laws that place restrictions on the amount that can be charged to patients for providing them with copies of their medical records.

CIOX Health claims the HIPAA Omnibus Rule updates in 2013, “unlawfully, unreasonably, arbitrarily and capriciously,” restrict the fees that can be charged by providers and their business associates for providing copies of the health information stored on patients.

Changes to HIPAA Rules not only placed a limit on the fees, but also expanded the types of information that must be provided to patients, on request. Accessing some of that information, in particular health information that is not stored in electronic medical records, is costly. Yet, even though the costs of processing some requests are high, HIPAA limits charges to $6.50 according to the lawsuit.

CIOX Health argues that this flat rate fee is an arbitrary figure that bears no relation to the actual cost of honoring patient requests for copies of their health information, and such a low fee is hurting its business. CIOX Health wants the HHS to reverse the changes made to HIPAA in 2013 and 2016 with respect to how much can be charged and the provision of copies of any type of medical information.

While the flat fee of $6.50 is the maximum that can be charged, it should be noted that the maximum fee only applies if the healthcare provider or company chooses that option. HIPAA does not prevent healthcare organizations from charging more. If they choose not to charge a flat fee, they are permitted to charge patients “actual or average allowable costs for requests for electronic copies of PHI maintained electronically.” The HHS confirmed this in May 2016 in response to questions asked via its web portal.

Tremendous Financial Burdens on Healthcare Providers

In the lawsuit, CIOX Health says, “HHS’s continued application and enforcement of these rules impose tremendous financial and regulatory burdens on healthcare providers and threatens to upend the medical records industry that services them.”

These changes to HIPAA Rules “threaten to bankrupt the dedicated medical-records providers who service the healthcare industry by effectively and quite deliberately mandating that they fulfill a rapidly growing percentage of requests for protected health information at a net loss.”

The changes to the types of health information that must be provided on request now includes medical information in any form whatsoever, including electronic medical records in EHR systems, but also paper records and films that have been transferred to third parties.

In the case of electronic records, they can be located in several different virtual locations, while paper records and films may be stored in several different physical locations. Providing copies of complete record sets requires staff to be sent to each of those locations to retrieve the records, and even accessing multiple virtual locations is a time consuming and costly process. Records must also be verified and compiled, which all takes time.

CIOX Health serves more than 16,000 physician practices and processes tens of millions of requests for copies of medical records every year. The restrictions on charges has potentially hurt its business, according to the lawsuit.

This is not the only legal action that CIOX Health is involved in which is related to providing patients with copies of their medical records. CIOX is the co-defendant in a November 2017 lawsuit that claims more than 60 Indiana hospitals have been failing to provide copies of medical records to patients within 3 days, as required by the HITECH Act, even though they accepted payments and claimed that they were meeting HITECT Act requirements. The defendants are also alleged to have overcharged patients for copies of medical records.

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Achieving HIPAA Compliant File Sharing In and Outside the Cloud

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HIPAA compliant file sharing consists of more than selecting the right technology to ensure the security, integrity and confidentiality of PHI at rest or in transit. Indeed, you could implement the most HIPAA compliant file sharing technology available and still be a long way short of achieving HIPAA compliance.

It is not the technology that is at fault. Many Covered Entities and Business Associates fail to configure the technology properly or train employees how to use the technology in compliance with HIPAA. According to a recent IBM X-Force Threat Intelligence Report, 46% of data breaches in the healthcare industry are attributable to “inadvertent actors”.

Of the remaining 54% of data breaches in the healthcare industry, 29% are attributable to “outsiders”, while the remaining 25% are the work of “malicious insiders”. Therefore, if a Covered Entity implements HIPAA compliant file sharing technology, but fails to configure it properly, train employees how to use it compliantly, or introduce mechanisms to monitor access to PHI, it may only be 29% of the way towards achieving HIPAA compliance.

Understanding the Risks to PHI when Sharing Data

In order to fully understand the risks to PHI when sharing data, it is important to conduct a thorough risk assessment detailing how PHI is created, used, stored and shared – and what happens to the data once it has been shared. When the risk assessment is completed, it is necessary to conduct a risk analysis to identify vulnerabilities and weaknesses that could result in the unauthorized disclosure of PHI.

Part of the risk analysis should concern what happens to data shared with Business Associates. Business Associates should conduct their own risk assessments and risk analyses, and it is a HIPAA Security Officer´s duty to conduct due diligence on any Business Associate data is shared with, in order to ensure their file sharing procedures are also HIPAA compliant.

HIPAA Compliant File Sharing Exists Outside the Cloud

Most articles relating to file sharing and HIPAA compliance focus on the technology available to share files securely in the cloud. Although these articles provide valuable information about one specific area of sharing data, they do not address the subject of HIPAA compliant file sharing in its entirety – for example, when data is shared within a private network or in physical format.

As well as evaluating cloud-based technology for HIPAA compliant file sharing, HIPAA Security Officers should also consider access controls to files and folders stored on private networks and access logs to monitor when PHI is accessed – both online and in physical format. Done effectively, this should help prevent the #1 cause of HIPAA security breaches – employee snooping.

Explaining File Sharing and HIPAA Compliance to Employees

Employee snooping – viewing the healthcare records of family, friends, colleagues or personalities without authorization – may not result in headline data breaches, but it is a HIPAA violation – and a common one at that. However, without being told it is a violation, many employees would consider snooping no more than a misdemeanor with inquisitive intent.

Explaining that snooping is a HIPAA violation punishable by sanctions is a good foundation for explaining file sharing and HIPAA compliance to employees. It will help them better understand the seriousness of unauthorized disclosures of PHI and make them more careful about taking shortcuts “to get the job done” – a leading cause of data breaches in the healthcare industry attributable to “inadvertent actors”.

Train, Monitor, Sanction when Necessary, then Review

Whenever new HIPAA-related technology is introduced or working practices are changed, it is essential employees are provided with adequate training on the new technology or working practices. By using employee HIPAA training sessions to reinforce the message about file sharing and HIPAA compliance, the message will likely be better absorbed.

If the Covered Entity is able to support employee training with mechanisms to monitor access to PHI, and the enforcement of sanctions when necessary, the likelihood is “malicious insiders” will likely think twice before attempting to access PHI without authorization. Thereafter, HIPAA Security Officers should review policies and procedures to assess whether any further adjustments need to be made in order to ensure HIPAA compliant file sharing.

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