HIPAA Compliance News

Is It Possible to Have HIPAA Compliant Gmail?

Posted by HIPAA Journal

With around 1.5 million users, Gmail is the most popular email service but can Gmail be used by healthcare organizations to send protected health information? Is it possible to make Gmail HIPAA compliant?

Is Gmail HIPAA Compliant?

In order for Gmail to be HIPAA compliant, Google would have to ensure that the email platform is secure and meets the minimum standards for security laid down in the HIPAA Security Rule. A covered entity would also need to enter into a business associate agreement with Google covering Gmail, as Google would be classed as a business associate under HIPAA. While encryption for email is not mandatory under HIPAA, it is a requirement if emails containing protected health information are to be sent externally beyond the protection of a firewall. If emails are sent externally, they would need to be secured with end-to-end encryption.

Google has implemented excellent security and its email service meets the requirements of the HIPAA Security Rule. Google is willing to enter into business associate agreements with HIPAA-covered entities that cover its email service, so provided a BAA is obtained, that HIPAA compliance box is also checked. Encryption for email can be applied, so Google does offer an email services that can be made HIPAA compliant. However, while you can make Gmail HIPAA compliant, it is not compliant by default.

Google offers Gmail for free and this email service is not HIPAA compliant. The standard free email service, which includes an @gmail.com email address, is only intended for personal use.

To be compliant with HIPAA you need to use Google’s G Suite (formerly Google Apps) email service, for which a subscription must be paid. This paid email service is intended for use with a company-owned domain. @hipaajournal.com for example. Google offers a business associate agreement for G Suite, but its BAA does not cover its free @gmail.com email service.

If you pay for G Suite and obtain a BAA, your email is still not yet compliant. You must ensure that your emails are encrypted. Google only encrypts emails at rest, not in transit. To send PHI via Gmail-powered G Suite, you will need to pay for an end-to-end email encryption service.

There are many encryption services that are compatible with Gmail. You can use Google Apps Message Encryption (GAME) or a third-party email encryption solution such as those offered by Identillect, LuxSci, Paubox, RMail, Virtru, or Zix.

You must then ensure your employees are trained on the correct use of email, are aware of the internal and federal rules covering the transmission of PHI via email, and they must take care to ensure the emails are sent to the correct recipient. You must also obtain consent from patients to send their PHI via email.

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Does HIPAA Apply to Schools?

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HIPAA applies to healthcare providers, health plans, healthcare clearinghouses, and business associates of those entities but how does HIPAA apply to schools? In this post we explore when HIPAA applies to schools and how the Health Insurance Portability and Accountability Act intersects with the Family Educational Rights and Privacy Act (FERPA).

Does HIPAA Apply to Schools?

Generally, HIPAA does not apply to schools because they are not HIPAA covered entities, but in some situations a school can be a covered entity if healthcare services are provided to students. In such cases, HIPAA may still not apply because any student health information collected would be included in the students’ education records and education records are exempt from the HIPAA Privacy Rule as they are covered by FERPA.

More and more schools are offering healthcare services to their students. Medical professionals are employed by some schools, some have on-site health clinics, and they often dispense medications and administer vaccines. When healthcare services are provided, health information will be collected, stored, maintained, and transmitted. Even if a school employs nurses, psychologists, or physicians, schools are not usually classed as covered entities because they do not conduct healthcare transactions electronically for which the Department of Health and Human Services has adopted standards. Most schools fall into this category and are not covered entities so HIPAA does not apply.

Some schools employ a healthcare provider that conducts transactions electronically for which the HHS has adopted standards. In this case, the school would be classed as a HIPAA covered entity. The HIPAA Transactions and Code Sets and Identifier Rules would have to be followed when electronic transactions are conducted, but it would not be a requirement to comply with the HIPAA Privacy Rule if healthcare data is stored in education records, which are covered by FERPA. If health information is stored in education records, it is not classed as protected health information and is therefore not covered by the HIPAA Privacy Rule. The school would however have to comply with FERPA privacy requirements.

One scenario where the HIPAA Privacy Rule would apply is when a healthcare professional provides medical services such as vaccinations at the school but is not employed by the school. In this situation, the healthcare professional would be required to comply with HIPAA, the records would be covered by HIPAA while they are held by the healthcare professional, and that individual would be required to obtain authorization before the health information is disclosed to the school. When those records are added to the student’s education records by the school, FERPA would apply rather than HIPAA.

FERPA, HIPAA, and Private Schools

FERPA applies to all educational institutions that receive direct funding through programs administered by the Department of Education. FERPA therefore applies to public schools, but private schools are not typically covered by FERPA as they do not receive federal funding direct from the Department for Education. If the private school is not covered by FERPA, it may or may not be covered by HIPAA depending on whether it conducts electronic transactions for which the HHS has adopted standards. If it does, it would be required to comply with HIPAA although if not, neither HIPAA nor FERPA would apply.

Further Information

To help clear up confusion over disclosures of health information under FERPA and HIPAA, the U.S. Department of Education and the HHS’ Office for Civil Rights updated their joint guidance in December 2019. The updated guidance is available on this link.

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HIPAA Enforcement in 2019

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It has been another year of heavy enforcement of HIPAA compliance. HIPAA enforcement in 2019 by the Department of Health and Human Services’ Office for Civil Right (OCR) has resulted in 10 financial penalties. $12,274,000 has been paid to OCR in 2019 to resolve HIPAA violation cases.

2019 saw one civil monetary penalty issued and settlements were reached with 9 entities, one fewer than 2018. In 2019, the average financial penalty was $1,022,833.

HIPAA Enforcement in 2019 by the HHS' Office for Civil Rights

 

Particularly egregious violations will attract financial penalties, but some of the HIPAA settlements in 2019 provide insights into OCRs preferred method of dealing with noncompliance. Even when HIPAA violations are discovered, OCR prefers to settle cases through voluntary compliance and by providing technical assistance. When technical assistance is provided and covered entities fail to act on OCR’s advice, financial penalties are likely to be issued.

This was made clear in two of the most recent HIPAA enforcement actions. OCR launched compliance investigations into two covered entities after being notified about data breaches. OCR discovered in both cases that HIPAA Rules had been violated. OCR chose to provide technical assistance to both entities rather than issue financial penalties, but the covered entities failed to act on the guidance and a financial penalty was imposed.

Sentara Hospitals disagreed with the guidance provided by OCR and refused to update its breach report to reflect the actual number of patients affected. West Georgia Ambulance was issued with technical guidance and failed to take sufficient steps to address the areas of noncompliance identified by OCR.

If you are told by OCR that your interpretation of HIPAA is incorrect, or are otherwise issued with technical guidance, it pays to act on that guidance quickly. Refusing to take corrective action is a sure-fire way to guarantee a financial penalty, attract negative publicity, and still be required to change policies and procedures in line with the guidance.

There were two important HIPAA enforcement updates in 2019. OCR adopted a new interpretation of the Health Information Technology for Economic and Clinical Health (HITECH) Act’s requirements for HIPAA penalties and a new enforcement initiative was launched.

The HITECH Act of 2009 called for an increase in the penalties for HIPAA violations. On January 25, 2013, the HHS implemented an interim final rule and adopted a new penalty structure. At the time it was thought that there were inconsistencies in the language of the HITECH Act with respect to the penalty amounts. OCR determined that the most logical reading of the HITECH Act requirements was to apply the same maximum penalty of $1,500,000 per violation category, per calendar year to all four penalty tiers.

In April 2019, OCR issued a notice of enforcement discretion regarding the penalties. A review of the language of the HITECH Act led to a reduction in the maximum penalties in three of the four tiers. The maximum penalties for HIPAA violations were changed to $25,000, $100,000, and $250,000 for penalty tiers, 1, 2, and 3. (subject to inflationary increases).

2019 saw the launch of a new HIPAA Right of Access enforcement initiative targeting organizations who were overcharging patients for copies of their medical records and were not providing copies of medical records in a timely manner in the format requested by the patient.

The extent of noncompliance was highlighted by a study conducted by Citizen Health, which found that 51% of healthcare organizations were not fully compliant with the HIPAA Right of Access. Delays providing copies of medical records, refusals to send patients’ PHI to their nominated representatives or their chosen health apps, not providing a copy of medical records in an electronic format, and overcharging for copies of health records are all common HIPAA Right of Access failures.

The two HIPAA Right of Action settlements reached so far under OCR’s enforcement initiative have both resulted in $85,000 fines. With these enforcement actions OCR is sending a clear message to healthcare providers that noncompliance with the HIPAA Right of Access will not be tolerated.

Right of Access violations aside, the same areas of noncompliance continue to attract financial penalties, especially the failure to conduct a comprehensive, organization-wide risk analysis. 2019 also saw an increase in the number of cited violations of the HIPAA Breach Notification Rule.

HIPAA Compliance Issues Cited in 2019 Enforcement Actions

Noncompliance Issue Number of Cases
Risk Analysis 5
Breach Notifications 3
Access Controls 2
Business Associate Agreements 2
HIPAA Right of Access 2
Security Rule Policies and Procedures 2
Device and Media Controls 1
Failure to Respond to a Security Incident 1
Information System Activity Monitoring 1
No Encryption 1
Notices of Privacy Practices 1
Privacy Rule Policies and Procedures 1
Risk Management 1
Security Awareness Training for Employees 1
Social Media Disclosures 1

OCR’s HIPAA enforcement in 2019 also clearly demonstrated that a data breach does not have occurred for a compliance investigation to be launched. OCR investigates all breaches of 500 or more records to determine whether noncompliance contributed to the cause of a breach, but complaints can also result in an investigation and compliance review. That was the case with both enforcement actions under the HIPAA Right of Access initiative.

 

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Ambulance Company Settles HIPAA Violation Case with OCR for $65,000

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The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced a $65,000 settlement has been reached with West Georgia Ambulance, Inc., to resolve multiple violations of Health Insurance Portability and Accountability Act Rules.

OCR launched an investigation into the Carroll County, GA ambulance company after being notified on February 11, 2013 about the loss of an unencrypted laptop computer containing the protected health information of 500 patients. According the breach report, the laptop computer fell from the rear bumper of the ambulance and was not recovered.

The investigation uncovered longstanding noncompliance with several aspects of the HIPAA Rules. OCR discovered West Georgia Ambulance had not conducted a comprehensive, organization-wide risk analysis (45 C.F.R. § 164.308(a)(1)(ii)(A)), had not implemented a security awareness training program for its employees (45 C.F.R. § 164.308(a)(5)), and had failed to implement HIPAA Security Rule policies and procedures (45 C.F.R. § 164.316.).

OCR provided technical assistance to West Georgia Ambulance to help the firm address its compliance failures, but despite that assistance, OCR said no meaningful steps were taken to address the areas of noncompliance. A financial penalty was therefore warranted.

In addition to paying the $65,000 financial penalty, West Georgia Ambulance is required to adopt a corrective action plan to address all areas of noncompliance discovered by OCR during the investigation. OCR will also be scrutinizing West Georgia Ambulance’s HIPAA compliance program for two years to ensure HIPAA Rules are being followed.

“The last thing patients being wheeled into the back of an ambulance should have to worry about is the privacy and security of their medical information,” said OCR Director Roger Severino. “All providers, large and small, need to take their HIPAA obligations seriously.”

This is the 10th OCR HIPAA financial penalty of 2019. In total, $12,274,000 has been paid to OCR in 2019 to resolve noncompliance issues.

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DoE and OCR Issue Updated Guidance on Sharing Student Health Records under FERPA and HIPAA

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The Department of Education and the Department of Health and Human Services’ Office for Civil Rights have issued updated guidance on the sharing of student health records under the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability Act (HIPAA).

The guidance document was first released in November 2008 to help school administrators and healthcare professionals understand how FERPA and HIPAA apply to student educational and healthcare records. The guidance includes several Q&As covering both sets of regulations. Further questions and answers have been added to clear up potential areas of confusion about how HIPAA and FERPA apply to student records, including when it is permitted to share student records under FERPA and the HIPAA Privacy Rule without first obtaining written consent.

HIPAA applies to healthcare providers, health plans, healthcare clearinghouses, and business associates of those entities. HIPAA does not usually apply to schools, since health information collected by an educational institution would usually be classed as educational records under FERPA. The HIPAA Privacy Rule excludes educational records from the definition of protected health information, but there are instances where HIPAA and FERPA intersect.

The HIPAA Privacy Rule requires consent to be obtained prior to the sharing of health information for purposes other than treatment, payment, or healthcare operations. The guidance explains that in emergencies and situations when an individual’s health is at risk, educational institutions and healthcare providers may disclose a student’s health information to someone in a position to prevent or lessen harm, including to family, friends, caregivers, and law enforcement.

The guidance states that “Healthcare providers may share (protected health information) with anyone as necessary to prevent or lessen a serious and imminent threat to the health or safety of the individual, another person, or the public—consistent with applicable law (such as state statutes, regulations or case law) and the provider’s standards of ethical conduct.” It is also permissible to share psychotherapy notes and information about mental health issues and substance abuse disorder in certain situations. The update details the situations when these disclosures are permitted.

“This updated resource empowers school officials, healthcare providers, and mental health professionals by dispelling the myth that HIPAA prohibits the sharing of health information in emergencies,” said OCR Director Roger Severino.

The update also includes information on when protected health information or personally identifiable information can be shared about a student that poses a danger to themselves or others. Additionally, disclosures of health data to law enforcement and the National Instant Criminal Background Check System are also now included in the guidance.

“Confusion on when records can be shared should not stand in the way of protecting students while they are in school,” said U.S. Secretary of Education Betsy DeVos.  “This update will provide much-needed clarity and help ensure that students get the assistance they need, and school leaders have the information they need to keep students safe.”

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November 2019 Healthcare Data Breach Report

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In November 2019, 33 healthcare data breaches of 500 or more records were reported to the Department of Health and Human Services’ Office for Civil Rights (OCR). That represents a 36.5% decrease in reported breaches from October – The worst ever month for healthcare data breaches since OCR started listing breaches on its website in October 2009. The fall in breaches is certainly good news, but data breaches are still occurring at a rate of more than one a day.

600,877 healthcare records were exposed, impermissibly disclosed, or stolen in November. That represents a 9.2% decrease in breached healthcare records from October, but the average breach size increased by 30.1% to 18,208 records in November.

Largest Healthcare Data Breaches in November 2019

Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach Location of Breached PHI
Ivy Rehab Network, Inc. and its affiliated companies Healthcare Provider 125000 Hacking/IT Incident Email
Solara Medical Supplies, LLC Healthcare Provider 114007 Hacking/IT Incident Email
Saint Francis Medical Center Healthcare Provider 107054 Hacking/IT Incident Electronic Medical Record, Network Server
Southeastern Minnesota Oral & Maxillofacial Surgery Healthcare Provider 80000 Hacking/IT Incident Network Server
Elizabeth Family Health Healthcare Provider 28375 Theft Paper/Films
The Brooklyn Hospital Center Healthcare Provider 26312 Hacking/IT Incident Network Server
Utah Valley Eye Center Healthcare Provider 20418 Hacking/IT Incident Desktop Computer
Loudoun Medical Group d/b/a Comprehensive Sleep Care Center (“CSCC”) Healthcare Provider 15575 Hacking/IT Incident Email
Choice Cancer Care Healthcare Provider 14673 Hacking/IT Incident Email
Arizona Dental Insurance Services, Inc. d.b.a. Delta Dental of Arizona Health Plan 12886 Hacking/IT Incident Email

Causes of Healthcare Data Breaches in November 2019

Hacking/IT incidents dominated November’s breach reports and accounted for 63.6% of data breaches reported in November and 90.75% of the breached records (545,293). The average breach size was 25,966 records and the median breach size was 3,977 records.

There were 7 unauthorized access/disclosure breaches reported in November involving 16,586 healthcare records. The mean breach size was 2,369 records and the median breach size was 996 records.

There were 4 incidents involving the theft of 38,998 individuals’ protected health information. Two of the incidents involved electronic devices and two involved paper records. The mean breach size was 7,799 records and the median breach size was 3,237 records.

Phishing continues to be the most common cause of healthcare data breaches. 17 of the healthcare data breaches reported in November involved PHI stored in email accounts. The majority of those breaches were due to phishing attacks.

November 2019 Healthcare Data Breaches by Covered Entity Type

There were 28 healthcare provider data breaches reported in November and four breaches were reported by health plans. It was a good month for business associates, with only one breach reported, although a further two breaches had some business associate involvement.

 

November 2019 Healthcare Data Breaches by State

Data breaches were reported by covered entities in 19 states. California was the worst affected with 4 breaches, followed by Illinois, Missouri, New York, and Texas with three breaches each. Two breaches were reported by covered entities in Florida, North Carolina, and Pennsylvania, and there was one reported beach in each of Alaska, Arizona, Colorado, Connecticut, Indiana, Maryland, Michigan, Minnesota, Nebraska, Utah, and Virginia.

HIPAA Enforcement in November 2019

There were three financial penalties imposed on HIPAA-covered entities in November to resolve HIPAA violations.

University of Rochester Medical Center (URMC) settled its HIPAA violation case with OCR for $3,000,000. OCR launched an investigation after receiving two notifications about breaches due to lost or stolen devices. OCR investigated URMC in 2010 after the first device was lost and provided technical assistance. At the time, URMC recognized the high risk of storing ePHI on devices and the need for encryption, yet this was not implemented, and unencrypted portable electronic devices continued to be used. When OCR investigated the subsequent theft of a laptop computer, its investigators found URMC had failed to conduct an organization-wide risk analysis, risks had not been reduced to a reasonable and appropriate level, and URMC had not implemented appropriate device media controls.

Sentara Hospitals agreed to settle its HIPAA violation case with OCR for $2,175,000. OCR launched a compliance investigation in response to a complaint from a patient in April 2017. The patient had received a bill from Sentara containing another patient’s protected health information. Sentara Hospitals reported the breach as affecting 8 individuals, but OCR found that 577 letters had been misdirected to 16,342 different guarantors. Sentara Hospitals refused to update its breach report with the new total. OCR also found Sentara Hospitals had failed to enter into a business associate agreement with one of its vendors.

A substantial financial penalty was also imposed on The Texas Department of Aging and Disability Services (DADS). DADS had reported a breach of 6,617 patients’ ePHI to OCR in 2015. An error in a web application allowed ePHI to be accessed over the internet by individuals unauthorized to view the data. ePHI had been exposed for around 8 years. OCR investigated and found that DADS had failed to conduct an organization-wide risk analysis, there was a lack of access controls, and DADS failed to monitor information system activity. DADS settled the HIPAA violation case and paid a penalty of $1.6 million.

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Rep. Jayapal Seeks Answers from Google and Alphabet on Ascension Partnership

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Pressure is continuing to be applied on Google and its parent company Alphabet to disclose information about how the protected health information (PHI) of patients of Ascension will be used, and the measures put in place to ensure PHI is secured and protected against unauthorized access.

The partnership between Google and Ascension was announced on November 11, 2019 following the publication of a story in the Wall Street Journal. A whistleblower at Google had shared information with the WSJ and expressed concern that millions of healthcare records had been shared with Google without first obtaining consent from patients. It was also alleged that Google employees could freely download PHI.

In its announcement, Google stated that the collaboration – named Project Nightingale – involved migrating Ascension’s infrastructure to the cloud and that it was helping Ascension implement G Suite tools to improve productivity and efficiency. Patient data was also being provided to Google to help develop AI and machine learning technologies to improve patient safety and clinical quality. When the migration of data has been completed, Google will have access to the health data of around 50 million patients.

Google has confirmed it is a business associate of Ascension and has signed a business associate agreement and is fully compliant with HIPAA regulations, but many privacy advocates are concerned about the partnership. Several members of Congress have also expressed concern and are seeking answers about the safeguards that have been put in place to secure patient data and how patient data will be used. The HHS’ Office for Civil Rights has also confirmed it is investigating Google and Ascension to make sure HIPAA Rules have not been violated.

Earlier this month, Rep. Pramila Jayapal (D-Washington), a member of the House Judiciary Subcommittee on Antitrust, Commercial, and Administrative Law, wrote to Google and Alphabet expressing concern about the partnership. She has demanded answers to several questions about how protected health information has been obtained, the measures put in place to protect patient data, and how Google will be using the PHI.

“As Google and parent company Alphabet have engaged in an ever-widening acquisition of the highly personal health-related information of millions of people, Americans now face the prospect of having their sensitive health information handled by corporations who may misuse it,” wrote Rep. Jayapal in her Dec 6, 2019 letter. “I am especially concerned that your company has not provided sufficient assurances that this sensitive data will be kept safe, and that patients’ data is being acquired by your companies without their consent and without any opt-out provision.”

Rep. Jayapal is particularly concerned about how that information will be used. Google is amassing huge quantities of healthcare data from several sources. Google’s healthcare-focused AI unit, Medical Brain, is actively acquiring health data, Alphabet has partnered with the Mayo Clinic, and Google has acquired the UK startup, DeepMind. NHS data has already been provided to Google. Google is also looking to acquire Fitbit, which holds health-related data on 25 million users of its wearable devices.

“The fact that Google makes the vast majority of its revenue through behavioral online advertising—creating an incentive to commoditize all user information—renders the company’s expansion into health services all the more troubling,” wrote Rep. Jayapal.

Rep. Jayapal also pointed out that Google does not have a blemish-free track record when it comes to protecting health and medical information, referencing one incident in which chest X-ray images from the National Institute of Health were almost posted online before Google realized they contained personally identifiable information. She also stated there is an active lawsuit that claims Google companies have obtained patient information from a major medical facility and DeepMind was found to have violated the Data Protection Act in the UK by using patient data to develop new apps.

Rep. Jayapal has given Google and Alphabet until January 5, 2020 to answer her questions, as detailed below:

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$85,000 Penalty for Korunda Medical for HIPAA Right of Access Failures

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The Department of Health and Human Services’ Office for Civil Rights has announced its second enforcement action under its HIPAA Right of Access Initiative. Florida-based Korunda Medical has agreed to settle potential violations of the HIPAA Right of Access and will adopt a corrective action plan and bring its policies and procedures in line with the requirements of the HIPAA Privacy Rule.

In March 2019, OCR received a complaint from a patient who alleged she had not been provided with a copy of her medical records in the requested electronic format despite making repeated requests. The complainant alleged that Korunda Medical refused to send an electronic copy of her medical records to a third party and was overcharging patients for providing copies of their medical records. Under HIPAA, covered entities are only permitted to charge a reasonable, cost-based fee for providing access to patients’ protected health information.

The initial complaint was filed with OCR on March 6, 2019. On March 18, 2019, OCR provided technical assistance to Korunda Medical on the HIPAA Right of Access and closed the complaint. Four days later, a second complaint was received which demonstrated continued noncompliance with the HIPAA Right of Access. On May 8, 2019, OCR advised Korunda Medical that a compliance investigation had been launched. As a result of OCR’s intervention, the complainant was provided with a copy of her medical records free of charge. Continued noncompliance with the HIPAA Right of Access resulted in a $85,000 financial penalty for Korunda Medical.

“For too long, healthcare providers have slow-walked their duty to provide patients their medical records out of a sleepy bureaucratic inertia. We hope our shift to the imposition of corrective actions and settlements under our Right of Access Initiative will finally wake up healthcare providers to their obligations under the law,” said OCR Director, Roger Severino.

The HIPAA Right of Action Initiative is a HIPAA enforcement drive to ensure HIPAA-covered entities are providing patients with copies of their medical records in a timely manner, in the format of their choosing, and without being overcharged. The first enforcement action under this initiative was announced in September 2019. Bayfront Health St Petersburg was also required to pay a financial penalty of $85,000 to resolve HIPAA Right of Access failures.

This is the ninth HIPAA enforcement action of 2019. OCR has settled 8 HIPAA violation cases this year and has issued one civil monetary penalty, with the financial penalties ranging from $10,000 to $3 million. So far in 2019, $12,209,000 has been paid to OCR to resolve HIPAA violations.

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Amazon Lex is Now HIPAA Compliant

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Amazon has announced that the Amazon Lex chatbot service now supports HIPAA compliance and can be used by healthcare organizations without violating Health Insurance Portability and Accountability Act Rules.

Amazon Lex is a service that allows customers to build conversational interfaces into applications using text and voice. It allows the creation of chatbots that use lifelike, natural language to engage with customers, ask questions, collect and give out information, and complete a range of different tasks such as scheduling appointments. The conversational engine that powers Amazon Lex is also used by Amazon Alexa.

Until recently, there was limited potential for use of Amazon Lex in healthcare as the solution was not HIPAA-compliant and could therefore not be used in connection with electronic protected health information (ePHI). The service was also not covered by Amazon’s business associate agreement (BAA).

On December 11, 2019, Amazon confirmed that Amazon Lex is now included in its AWS business associate agreement (BAA) addendum and that the service is eligible for use with workloads involving ePHI, provided that a BAA is in place. Amazon Lex has been subjected to third-party security assessments under multiple AWS compliance programs, and in addition to being HIPAA eligible is also compliant with PCI and SOC.

As with any software solution, a BAA does not guarantee compliance. Amazon has ensured appropriate safeguards have been implemented to ensure the confidentiality, integrity, and availability of ePHI, but it is the responsibility of users to ensure that the solution is implemented correctly and used in a manner that complies with HIPAA Rules.

Amazon has released a whitepaper on Architecting for HIPAA Security and Compliance on AWS, which details best practices for configuring AWS services that store, process, and transmit ePHI. Guidelines on the administration of Amazon Lex have also been published.

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