HIPAA Compliance News

What is Considered Protected Health Information Under HIPAA?

Posted by HIPAA Journal

Health, treatment, or payment information, and any identifiers maintained with this information, is considered Protected Health Information under HIPAA if the information is created, received, maintained, or transmitted by a “covered entity” or by a “business associate”.

However, because there are times when a covered entity might not maintain identifying information with health, treatment, or payment information, there is no definitive list of what is considered Protected Health Information under HIPAA.

A lack of understanding about what is considered Protected Health Information under HIPAA is one of the primary reasons for HIPAA-related complaints to HHS´ Office for Civil Rights.

Protected Health Information ChecklistThis is not surprising, as there are times when the same information can be both protected and non-protected depending on how it is maintained.

This article aims to provide you with the full and correct definition of Protected Health Information.

HIPAA rules and regulations are substantially about protecting PHI and we recommend you use our Protected Health Information Checklist to understand what is required for the protection of PHI.

What is Considered Protected Health Information under HIPAA?

To best understand what is considered Protect Health Information under HIPAA it is necessary to review not only the definition of Protected Health Information under HIPAA in 45 CFR §160.103, but also the definitions of “health information”, individually identifiable health information”, and “designated record set”.

This is because, when taking the four HIPAA PHI definitions into account, it is easier to determine what information is protected under HIPAA and when.

Starting with health information, this is defined as any information, including genetic information, whether oral or recorded in any form or medium, that:

  1. Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
  2. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

Thereafter, the definition of individually identifiable health information is much the same, other than the definition only applies to health care providers, health plans, employers (in the role of an administrator of a self-insured health plan), and health care clearinghouses, and only relates to information that identifies or could be used to identify the individual who is the subject of the health information or the individual´s family, employer, or members of their household.

What is Considered Protected Health Information Under HIPAA The Protected Health Information definition is similar to that for individually identifiable health information when maintained or transmitted by a Covered Entity other than PHI excludes health information maintained in students´ educational records (as these are protected by the Family Educational Rights and Privacy Act) and health information maintained by a Covered Entity in its role as an employer (i.e., health information relating to an employee´s absence from work).

It is important to note these HIPAA PHI definitions only apply to health care providers, health plans, and health care clearing houses that qualify as HIPAA Covered Entities, and only to Business Associates while they are performing a service for or on behalf of a Covered Entity.  For more information about when the Protected Health Information definition may not apply to a health care provider or health plan, please see “The HIPAA Definition of Covered Entities Explained”.

Compliance Issues Regarding Protected Health Information under HIPAA

HHS´ Office for Civil Rights updates an Enforcement Highlights webpage on which it lists the compliance issues most often alleged in complaints in order of frequency. Because a single data breach can affect many thousands of individuals, it is not surprising to see impermissible uses and disclosures at the top of the list. However, the next four items imply a lack of understanding about what is considered Protected Health Information under HIPAA:

  • Impermissible uses and disclosures of PHI
  • Lack of safeguards for (non-electronic) PHI
  • Failures to provide patient access to PHI
  • Lack of Administrative Safeguards for electronic PHI
  • Violations of the minimum necessary standard

It is worth noting that, other than mandatory breach notifications, the most likely source of a complaint to HHS´ Office for Civil Rights is a patient. It is not necessarily be the case that Covered Entities, Business Associates, and members of their respective workforces have a lack of understanding about what is considered Protected Health Information under HIPAA, but rather that patients need better educating about what HIPAA Protected Health Information is.

In a perfect world, an explanation of what HIPAA Protected Health Information is would be covered in the Notice of Privacy Practices. However, most Notices of Privacy Practices already contain more information than most patients are prepared to read; and, as will become evident in later sections of this article, explaining what is covered under HIPAA – and what is not – will likely raise more questions than answers for patients wishing to exercise their Privacy Rule rights.

In order to reduce the number of complaints to HHS´ Office for Civil Rights, it is advisable for Covered Entities and Business Associates to ensure all members of the workforce have a thorough understanding of what is considered Protected Health Information under HIPAA – not only to answer patients´ questions, but also to carry out their functions within the Covered Entity or Business Associate in compliance with HIPAA.

Designated Record Sets and What Information is Protected by HIPAA

Considered Protected Health Information Under HIPAAThe definition of designated record sets appears in the introduction to the Privacy Rule in 45 CFR §164.501. This standard defines designated record sets as “a group of records maintained by or for a Covered Entity that is the medical records and billing records about individuals […] or the enrollment, payment, and claims information maintained by or for a health plan that is used in whole or in part by or for the Covered Entity to make decisions about individuals.”

This definition is followed by a footnote that explains a record can be “any item, collection, or grouping of information that includes Protected Health Information and is maintained, collected, used, or disseminated by or for a Covered Entity.” While this may be a little confusing to follow – and likely difficult to make clear to patients unfamiliar with the terminology of HIPAA – an explanation of what information is protected by HIPAA could be explained thus:

  • Protected Health Information is health information (i.e., a diagnosis, a test result, an x-ray, etc.) that is maintained in the same record set as individually identifiable information (i.e., a name, an address, a phone number, etc.).
  • Any other non-health information included in the same record set assumes the same protections as the health information. However, when non-health information is maintained outside the record set, the protections do not apply.
  • A Covered Entity may maintain multiple record sets about an individual (i.e., a patient or plan member), but individuals only have the right to access and request amendments to information maintained in designated record sets.

This explanation of what information is protected by HIPAA can help reduce patients´ misunderstandings about what is considered Protected Health Information under HIPAA and reduce the volume of complaints to HHS´ Office for Civil Rights. It can also accelerate the flow of information within a health care facility when members of the workforce understand that not every piece of information relating to a patient has to be locked down behind access controls.

Examples of Protected Health Information and Why There is No List of Protected Health Information

Many examples of Protected Health Information refer to the PHI identifiers listed under the safe harbor method of de-identification in 45 CFR §164.514. It is now more than twenty years since this Protected Health Information list was compiled and it is very out of date. For example, in many cases Social Security Numbers have been replaced by Medicare Beneficiary Identifiers, social media handles did not exist when the list of PHI identifiers was compiled, and few people had Emotional Support Animals.

Indeed, Emotional Support Animals are a good example of when non-health information can be both protected and non-protected depending on how information is maintained. If information relating to a patient´s Emotional Support Animal is maintained in a record set, it assumes the same protections as the patient´s health information. However, if it is maintained in a separate database that does not contain health information (i.e., to accommodate transport requirements) it is not protected.

It is because of scenarios such as this that there is no list of Protected Health Information. Protected Health Information can be any information relating to an individual that is maintained in the same record set as the individual´s health information. To include non-health information that is not maintained in a record set in a list of Protected Health Information (i.e., license plate numbers, device identifiers, URLs, etc.) is unnecessary and not the objective of the Privacy Rule.

In conclusion, there is no doubt that understanding what is considered Protected Health Information under HIPAA can be complicated; but, by identifying what is Protected Health Information – and what isn´t – and knowing when protections are applied to non-health information – and when they are not – Covered Entities and Business Associates can accelerate the flow of information and reduce the number of unjustified complaints by patients to HSS´ Office for Civil Rights.

FAQs

What does HIPAA protect?

HIPAA protects the privacy of individually identifiable health information via the provisions of the Privacy Rule. However, it is important to be aware that HIPAA provides a “federal floor” of privacy protections. In many locations, states have passed privacy laws with more stringent protections than HIPAA and, in these locations, state law preempts HIPAA.

What information is protected by HIPAA?

The information protected by HIPAA is all health information relating to an individual´s past, present, or future physical or mental health or condition, the provision of health care to the individual; or the past, present, or future payment for the provision of health care to the individual. Any information that can identify – or be used to identify – the subject of the information is also protected by HIPAA when it is maintained in the same designated record set as an individual’s health information.

What is considered HIPAA information?

What is considered HIPAA information is any health information or connected identifier “created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse”. Many of these organizations are not HIPAA covered entities and not required to comply with HIPAA.

What is considered PHI under HIPAA?

What is considered PHI under HIPAA is any combination of health information and identifiers created, received, maintained, or transmitted by a covered entity. However, although the term combination is used in this definition, PHI can be a single item – for example, a picture of a baby sent to a pediatrician.

When maintained in the same designated record set as information relating to health, treatment, or payment, PHI covered under HIPAA includes any item of information that could be used to identify the subject of the health, treatment, or payment information.

Using this HIPAA definition of PHI, examples of Protected Health Information include an individual’s LGBTQ status, information about their emotional support animal, and contact information for a family member, friend, or support group – if this information could be used to identify the subject of the health, treatment, or payment information.

What is not considered PHI under HIPAA?

There are numerous examples of what is not considered PHI under HIPAA. One of the most common is students´ health information when it is created, received, maintained, or transmitted by a public school or college; for although the school or college may qualify as a partial covered entity, students´ medical records are considered to be part of their educational records under FERPA.

What information can be shared without violating HIPAA?

All information can be shared without violating HIPAA provided it is shared for a permissible use or disclosure or the entity sharing the information has obtained a written authorization from the subject of the information. With regards to written authorizations, it is important to be aware that individuals have the right to revoke their authorizations at any time.

What is not included in PHI?

What is not included in PHI depends on where information is maintained. PHI is any combination of health information and identifiers when they are maintained in the same designated record set. However, when health information and individual identifiers are maintained separately from each other, the identifiers alone are not considered protected health information under HIPAA. For example, jdoe@yahoo.com, Stillwater MN, and auto registration AYP 197 are not included in PHI when they are not maintained with health information in the same designated record set.

What is the difference between PII, PHI, and IIHA?

The difference between PII, PHI, and IIHA is that PII is Personally Identifiable Information used outside a healthcare context, while PHI (Protected Health Information) and IIHA (Individually Identifiable Health Information) is the same information used within a healthcare context. Although PHI is the more commonly used acronym in HIPAA, both PHI and IIHI are protected by the Privacy and Security Rules because they mean exactly the same thing.

Would patient information such as “Mr. Brown from New York” be considered PHI?

Patient information such as “Mr. Brown from New York” could be considered PHI if the information is maintained in a designated record set with either Mr. Brown´s health information or the health information of a family member, employee, or close personal friend.

Are email addresses that don´t reveal a person’s name considered identifiers for PHI purposes?

Email addresses that don’t reveal a person’s name are considered identifiers for PHI purposes if the email address is maintained in the same designated record set as an individual’s health information. This is because it is quite simple to find out who an email address such as “anonymous@xyz.com“ belongs to by doing a little research on social media or using a reverse email lookup tool on the Internet. Even if social media or a reverse lookup tool does not give you the individual´s name, you will still be able to find enough information about the individual for the email address – when maintained with health information – to be considered PHI.

What is the difference between an allowable disclosure of PHI and an incidental disclosure?

The difference between an allowable disclosure of PHI and an incidental disclosure is that covered entities are allowed to disclose PHI for treatment, payment, and health care operations. An incidental disclosure is a secondary, accidental disclosure that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another disclosure permitted by the Privacy Rule – for example, if a physician invites a health plan employee to his office to discuss payments, and the health plan employee passes a patient he or she recognizes in the waiting room.

How do you determine what a reasonably anticipated threat to PHI is?

You determine what a reasonably anticipated threat to PHI is by conducting frequent risk analyses in order to identify threats to the integrity of PHI. If the threats could be reasonably anticipated, covered entities and business associates are required to implement measures to protect against the threats occurring, or mitigate the consequences if the threats occur.

What information does HIPAA protect?

The information HIPAA protects is all individually identifiable health information that relates to an individual´s past, present, or future medical condition, treatment for medical conditions, and payment for treatments. As well as medical, treatment, and payment information, any information maintained in the same designated record set as the individually identifiable health information that could be used to identify the individual is also protected.

Who can access information under HIPAA?

The answer to the question of who can access information under HIPAA has three parts. 1. The subject of the information and representatives of HHS´ Office of Civil Rights must have access to information when requested. 2. Authorized personnel and certain organizations can have access to information under HIPAA if it involves a permissible use or disclosure as defined by the Privacy Rule. 3. All other requests for access to information under HIPAA must be accompanied by a written authorization from the patient.

Is gender a HIPAA identifier?

Gender is a HIPAA identifier if the information could be used to identify the subject of health information maintained or transmitted by a Covered Entity – or by a Business Associate acting on a Covered Entity´s behalf. The gender of an individual – and their LGBTQ status – is always Protected Health Information when it is maintained or transmitted in the same designated record set as an individual’s health information.

What health information is protected by federal law?

What health information is protected by federal law depends on the federal law and whether it is preempted by state law. For example, HIPAA laws protect health information relating to an individual’s past, present, or future physical or mental health condition, treatment for the condition, and payment for treatment.

However other federal laws exist that also protect health information in certain circumstances. For example, the amended Confidentiality of Alcohol and Drug Abuse Patient Records Regulations protect the confidentiality of substance use disorder patient records and is enforced by the Substance Abuse and Mental Health Services Administration (an agency within HHS).

Under the Public Health Service Act, any health information provided to a family planning agency is protected even if the family planning agency is not a HIPAA Covered Entity. Similarly, any health information provided to any federal government agency is protected by the Privacy Act, while any health information maintained about a student by a school is protected by FERPA.

With regards to state law, Illinois is one of many states that has introduced regulations that preempt HIPAA in specific areas. In this case, Illinois’ Biometric Information Privacy Act regulates the collection, use, and handling of biometric identifiers and information by private companies. Texas has similar regulations included in its Medical Records Privacy Act.

What is considered HIPAA information?

The term HIPAA information can relate to any standard in the text of the Health Insurance Portability and Accountability Act inasmuch as the term could mean information about a pre-existing condition for insurance purposes, information contained in a Medicare claims transaction, or the right to withhold information from an insurance provider when treatment has been paid for privately.

What is HIPAA protected information?

HIPAA protected information is most often considered to be the contents of a designated record set – i.e., both the health information in the designated record set and any non-health information that identifies or could be used to identify the subject of the health information. This description can also include any data relating to a family member, friend, or employer that could identify the individual.

How should you explain the definition of PHI under HIPAA to a patient?

To explain the definition of PHI under HIPAA to a patient, it is a good idea to create a web page with a full explanation of what is protected under HIPAA and under what circumstances it is protected. A link to the web page could be included in the Notice of Privacy Practices with a note asking patients to review the web page prior to making a complaint.

When is the disclosure of HIPAA data a HIPAA violation?

Any disclosure of HIPAA data is a HIPAA violation if it is permitted by the Privacy Rule or authorized by the individual to whom the data relates. A HIPAA violation of this nature is usually considered to be a data breach; and, depending on the consequences of the violation, may have to be reported to HHS´ Office for Civil Rights and the affected individual(s).

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Security Breaches in Healthcare in the Last Three Years

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There have been 955 major security breaches in healthcare in the last three years that have resulted in the exposure/theft of 135,060,443 healthcare records. More than 41% of the population of the United States have had some of their protected health information exposed as a result of those breaches, which have been occurring at a rate of almost one a day over the past three years.

There has been a steady rise in reported security beaches in healthcare in the last three years. In 2015 there were 270 data breaches involving more than 500 records reported to the Department of Health and Human Services’ Office for Civil Rights. The figure rose to 327 security breaches in 2016, and 342 security breaches in 2017.

reported healthcare data breaches in 2017

More healthcare security breaches are being reported than at any other time since HIPAA required covered entities to disclose data breaches, although the number of individuals affected by healthcare data breaches has been declining year-over year for the past three years.

In 2015, a particularly bad year for healthcare industry data breaches, 112,107,579 healthcare records were exposed or stolen. The majority of those records were exposed in three data breaches. The 78.8 million-record data breach at Anthem Inc., the 11 million-record breach at Premera Blue Cross, and the 10 million-record breach at Excellus Health Plan.

Other major security breaches in 2015 include the University of California Los Angeles Health breach of 4.5 million records and Medical Informatics Engineering breach of 3.9 million records.

In 2016, 14,679,461 healthcare records were exposed or stolen, with three incidents involving more than 1 million records: The 3.62 million-record breach at Banner Health, the 3.46 million-record breach at Newkirk Products, Inc., and the 2.21 million-record breach at 21st Century Oncology.

In 2017, the worst year for healthcare security incidents in terms of the number of breaches reported, there were 3,286,498 healthcare records exposed or stolen. There were two breaches involving more than half a million records. The 500,000-record breach at Airway Oxygen, Inc., and the 697800-record breach at Commonwealth Health Corporation

15 Largest Security Breaches in Healthcare in the Last Three Years

 

Rank Year Covered Entity Entity Type Records Exposed/Stolen Breach Cause
1 2015 Anthem, Inc. Affiliated Covered Entity Health Plan 78800000 Hacking/IT Incident
2 2015 Premera Blue Cross Health Plan 11000000 Hacking/IT Incident
3 2015 Excellus Health Plan, Inc. Health Plan 10000000 Hacking/IT Incident
4 2015 University of California, Los Angeles Health Healthcare Provider 4500000 Hacking/IT Incident
5 2015 Medical Informatics Engineering Business Associate 3900000 Hacking/IT Incident
6 2016 Banner Health Healthcare Provider 3620000 Hacking/IT Incident
7 2016 Newkirk Products, Inc. Business Associate 3466120 Hacking/IT Incident
8 2016 21st Century Oncology Healthcare Provider 2213597 Hacking/IT Incident
9 2015 CareFirst BlueCross BlueShield Health Plan 1100000 Hacking/IT Incident
10 2016 Valley Anesthesiology Consultants, Inc. d/b/a Valley Anesthesiology and Pain Consultants Healthcare Provider 882590 Hacking/IT Incident
11 2016 County of Los Angeles Departments of Health and Mental Health Healthcare Provider 749017 Hacking/IT Incident
12 2017 Commonwealth Health Corporation Healthcare Provider 697800 Theft
13 2015 Virginia Department of Medical Assistance Services (VA-DMAS) Health Plan 697586 Hacking/IT Incident
14 2016 Bon Secours Health System Incorporated Healthcare Provider 651971 Unauthorized Access/Disclosure
15 2015 Georgia Department of Community Health Health Plan 557779 Hacking/IT Incident

 

Main Causes of Security Breaches in Healthcare in the Last Three Years

The three main causes of security breaches in healthcare in the last three years were hacking/IT incidents, unauthorized access and disclosure incidents, and the loss/theft of physical records and unencrypted electronic devices containing ePHI.

There has been a downward trend in the number of theft/loss incidents over the past three years as healthcare organizations have started encrypting records on portable electronic devices. However, improper disposal incidents have risen year over year as have hacking incidents. In 2017, hacking/IT incidents were the main cause of healthcare data breaches.

healthcare data breaches in 2017 (hacking)

healthcare data breaches in 2017 (Unauthorized access/disclosures)

Healthcare Data Breaches in 2017 (loss/theft)

Financial Penalties for Security Breaches in Healthcare in the Last Three Years

In addition to annual increases in data breaches, financial penalties for HIPAA violations have also been increasing, both in terms of number of settlements and civil monetary penalties issued and the penalty amounts.

The HHS’ Office for Civil Rights is now enforcing HIPAA Rules far more aggressively and multi-million-dollar fines are regularly issued. The last three years have seen 29 HIPAA covered entities and business associates financially penalized for data breaches that have occurred as a result of noncompliance with HIPAA Rules.

In the last three years, the HHS’ Office for Civil Rights has collected $49,091,700 in financial penalties from its enforcement actions. The average settlement amount in 2017 was $1.94 million.

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Is Uber Health HIPAA Compliant?

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This March, Uber officially launched Uber Health – A platform that makes arranging transport for patients more straightforward and cost effective. The service should benefit patients and providers alike, although questions have been raised about HIPAA and whether Uber Health is HIPAA compliant.

What is Uber Health?

Uber Health consists of an online dashboard that healthcare providers can use to schedule transport for their patients in advance. Provided the patient has a mobile phone, he/she will receive a notification about the collection and drop off location via text message. In contrast to the standard Uber service, Uber Health does not require the use of a smartphone app.

By using Uber Health, healthcare providers can potentially reduce the number of no shows and ensure more patients turn up on time for their appointments. Rides can be scheduled when the patient is in a facility, ensuring they have transport arranged for follow up appointments. The service could also be used for caregivers and staff.

The official launch of the platform comes after a trial on around 100 healthcare organizations, with the platform now made available to healthcare organizations of all sizes.

Uber Health HIPAA compliant ride scheduling service

Image Source: Uber

Is Uber Health HIPAA Compliant?

Any HIPAA-covered entity that signs up to use Uber Health would be required to enter patient names and appointment times into the system, so prior to using the service a business associate agreement would need to be obtained. Uber is happy to sign BAAs with all participating healthcare organizations.

Uber maintains on its website that Uber Health is HIPAA compliant and any data entered via the dashboard is protected by privacy and security controls in line with HIPAA standards. All data remains secured in the system, and the only information passed to its drivers is the name of the patient, the pickup and drop off time, and the collection point and drop off location, as with any taxi service. No protected health information is passed to the drivers.

Uber says it consulted with Clearwater Compliance while developing the Uber Health service to ensure all requirements of HIPAA were satisfied. Uber has conducted HIPAA-compliant risk analyses and completed compliance assessments and has been confirmed to be compliant with HIPAA Rules.

Provided a business associate agreement is obtained from Uber, Uber Health is a HIPAA compliant ride sharing service and can be used without violating HIPAA Rules.

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Legislation Changes and New HIPAA Regulations in 2018

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The policy of two out for every new regulation introduced means there are likely to be few, if any, new HIPAA regulations in 2018. However, that does not mean it will be all quiet on the HIPAA front. HHS’ Office for Civil Rights (OCR) director Roger Severino has indicated there are some HIPAA changes under consideration.

OCR is planning on removing some of the outdated and labor-intensive elements of HIPAA that provide little benefit to patients, although before HIPAA changes are made, OCR will seek feedback from healthcare industry stakeholders.

As with previous updates, OCR will submit notices of proposed rulemaking and will seek comment on the proposed changes. Those comments will be carefully considered before any HIPAA changes are made.

The full list of proposed changes to the HIPAA Privacy Rule have not been made public, although Severino did provide some insight into what can be expected in 2018 at a recent HIPAA summit in Virginia.

Severino explained there were three possible changes to HIPAA regulations in 2018, the first relates to enforcement of HIPAA Rules by OCR.

Since the introduction of the Enforcement Rule, OCR has had the power to financially penalize HIPAA covered entities that are discovered to have violated HIPAA Rules or not put sufficient effort into compliance. Since the incorporation of HITECH Act into HIPAA in 2009, OCR has been permitted to retain a proportion of the settlements and CMPs it collects through its enforcement actions. Those funds are used, in part, to cover the cost of future enforcement actions and to provide restitution to victims. To date, OCR has not done the latter.

OCR is considering requesting information on how a proportion of the settlements and civil monetary penalties it collects can be directed to the victims of healthcare data breaches and HIPAA violations.

One area of bureaucracy that OCR is considering changing is the requirement for covered entities to retain signed forms from patients confirming they have received a copy of the covered entity’s notice of privacy practices. In many cases, the forms are signed by patients who just want to see a doctor. The forms are not actually read.

One potential change is to remove the requirement to obtain and store signed forms and instead to inform patients of privacy practices via a notice in a prominent place within the covered entity’s facilities.

Severino also said OCR is considering changing HIPAA regulations in 2018 relating to good faith disclosures of PHI. OCR is considering formally clarifying that disclosing PHI in certain circumstances is permitted without first obtaining consent from patients – The sharing of PHI with family members and close friends when a patient is incapacitated or in cases of opioid drug abuse for instance.

While HIPAA does permit healthcare providers to disclose PHI when a patient is in imminent harm, further rulemaking is required to cover good faith disclosures.

While these HIPAA changes are being considered, it could take until 2019 before they are implemented.

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Study Suggests Improper Disposal of PHI is Commonplace

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A recent study (published in JAMA) has highlighted just how frequently hospitals are disposing of PHI in an insecure manner. While the study was conducted in Canada, which is not covered by HIPAA, the results highlight an important area of PHI security that is often overlooked.

Improper Disposal of PHI is More Common than Previously Thought

Researchers at St. Michael’s Hospital in Toronto checked recycled paperwork at five teaching hospitals in Canada. Each of the five hospitals had policies covering the secure disposal of documents containing PHI and separate recycling bins were provided for general paperwork and documents containing sensitive information. The latter were shredded before disposal.

Despite the document disposal policies, paperwork containing personally identifiable information (PII) and personal health information (PHI) were often incorrectly placed in the bins. The researchers identified 2,867 documents containing PII and 1,885 items containing personally identifiable health information in the standard recycling bins. 1,042 documents contained high sensitivity PII, 843 items contained PII with medium sensitivity, and 802 contained low sensitivity data.

821 items included clinical notes, summaries, and medical reports, there were 385 discarded labels with patient identifiers clearly visible, 345 billing forms, 340 diagnostic test results, and 317 requests and communications containing personally identifiable information.

The study shows that even with policies in place covering the proper disposal of paper records, sensitive information is still regularly disposed of in an insecure manner.

Improper Disposal of PHI in the United States

In February, 23% of the month’s healthcare data breaches involved paper/film records. Those breaches impacted 121,607 individuals. In January 33% of the month’s data breaches involved paper/film records. Those breaches impacted 13,513 individuals.

Overall, between January 1, 2010 and December 31, 2017, there have been 514 healthcare data breaches involving 500 or more paper records. Those breaches have impacted 3,393,240 individuals.

Breaches of Physical PHI

Patients Impacted by Breaches of Physical PHI

Improper Disposal of Paper/Films and ePHI

Patients Impacted by Improper Disposal of all Forms of PHI

Many privacy incidents involving paper records only impact a few patients and are not made public, so it is difficult to determine exactly how many incidents have occurred and how many patients have been impacted, although the Canadian study suggests these types of breaches are incredibly common.

To prevent these types of privacy breaches, HIPAA covered entities should carefully review their policies, procedures and physical safeguards for PHI and strengthen controls as appropriate.

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How to Become HIPAA Compliant

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How to become HIPAA compliant is one of the biggest challenges for many businesses operating in the healthcare and health insurance industries. Nonetheless, businesses who operate in these industries – and service providers that do business with them – must understand what HIPAA compliance entails and how to become HIPAA compliant.

What is HIPAA Compliance?

For many businesses operating in the healthcare and health insurance industries – and for businesses outside these industries that collect individually identifiable health information – HIPAA compliance means complying with any standards of the HIPAA Administrative Simplification Regulations that are relevant to their operations and that are not preempted by any other state or federal regulations.

Not every business operating in the healthcare and health insurance industries is required to become HIPAA compliant. The HIPAA Administrative Simplification Regulations only apply to businesses that qualify as a HIPAA Covered Entity or Business Associate according to the definitions provided in the HIPAA General Provisions (45 CFR §160.103) and to health-related businesses regulated by the Federal Trade Commission.

Additionally, not every business operating in the healthcare and health insurance industry is required to comply with every standard of the HIPAA Administrative Simplification Regulations. For example, healthcare providers that outsource claims and billing operations do not have to comply with Part 162 of the Regulations – although it is necessary to know what they are in order to conduct due diligence on third party service providers.

Therefore, HIPAA compliance entails reviewing the HIPAA Administrative Simplification Regulations, identifying which standards are relevant to your business’s operations (and which you need to be aware of in order to conduct due diligence on third party service providers), and comparing these standards with any state or federal regulations you may be subject to. Thereafter, follow the steps in the next section to become HIPAA compliant.

How to Become HIPAA Compliant

After identifying which standards your business needs to comply with to become HIPAA compliant, there is no one-size-fits-all path to compliance. Most businesses will already have some of the required measures in place to protect the privacy of individually identifiable health information or to safeguard the confidentiality, integrity, and availability of electronic Protected Health Information. Most will also have processes in place to comply with state Breach Notification Rules.

Therefore, the way to become HIPAA compliant is to compare the measures you need to implement with those you already have in place. This may mean you only have to fine-tune a number of policies and implement additional security procedures to comply with the HIPAA Privacy and Security Rules, or it may mean a complete overhaul of your compliance strategy to address shortcomings in how the privacy of individual identifiable health information is protected.

It is important that both your existing measures and those you introduce to become HIPAA compliant are documented, that you conduct a risk analysis to identify any remaining potential vulnerabilities, and that you provide HIPAA training to members of the workforce that have experienced a “material change” to working practices. It may also be necessary to amend existing Notices of Privacy Practices and to review Business Associate Agreements to ensure they are compliant.

Service providers with whom you do business also need to be made aware they must become HIPAA compliant if the service involves the disclosure (to the service provider) of Protected Health Information. Although it is in the service providers’ best interests to take responsibility for their own compliance, it may be necessary for your business to get involved with explaining to them the measures they need to implement in order to become HIPAA compliant.

Help with Becoming HIPAA Compliant

Becoming HIPAA compliant can be a daunting prospect, especially considering the severity of penalties for HIPAA violations and the consequences of a breach of Protected Health Information or patient privacy. Fortunately, there are a number of useful resources that can help businesses – both Covered Entities and Business Associates – become HIPAA compliant.

HIPAA Compliance Checklist

The first of these is a HIPAA compliance checklist. Although a comprehensive HIPAA checklist may cover more areas of compliance than is necessary for every business, one of the benefits of a comprehensive checklist is that it can help businesses identify areas of compliance they may have overlooked when reviewing the HIPAA Administrative Simplification Regulations.

HHS Guidance Materials

The second useful resource is the guidance materials published by the Department of Health and Human Services. This resource tends to deal with more specific areas of compliance (rather than general areas covered by a compliance checklist) and some businesses may find the depth of detail unnecessary while they are in the early stages of becoming HIPAA compliant.

HIPAA Compliance Software

Depending on where your business is on the path to becoming HIPAA compliant, HIPAA compliance software can help you identify gaps between your existing measures and those you need to implement, or double-check you have covered everything you need to. Additionally, adopting HIPAA compliance software indicates a good faith attempt to comply with HIPAA.

How to Remain HIPAA Compliant

Not only can becoming HIPAA compliant be a daunting prospect, remaining HIPAA compliant can also be a challenge. New threats to the confidentiality, integrity, and availability of electronic Protected Health Information are constantly emerging and poor compliance practices can creep in as members of the workforce take shortcuts “to get the job done”.

One of the best ways to remain HIPAA compliant is by using HIPAA compliance software to continually self-assess compliance. The auditing capabilities of the software will help you understand when additional security measures need to be implemented or when refresher training is necessary to remind members of the workforce of their compliance responsibilities.

HIPAA compliance software can also help your business comply with the requirement to conduct regular risk assessments and – all the time the software is being utilized – maintains the impression of a good faith attempt to comply with HIPAA. This may be essential if your business is only just taking its first steps on the path to becoming HIPAA compliant.

How to Become HIPAA Compliant: FAQs

Who are the federal and state regulators of the HIPAA Rules?

The federal and state regulators of the HIPAA Rules are the Department of Health and Human Services (HHS), the Federal Trade Commission (FTC), and State Attorneys General. Reports of HIPAA violations are investigated by HHS’ Office for Civil Rights. The agency has the authority to impose civil penalties or refer violations to the Department of Justice if criminal activity is suspected. Non-HIPAA covered organizations – such as vendors of health apps – are regulated by the FTC.

At a state level, HIPAA compliance is regulated by State Attorneys General. State Attorneys General can also initiate complaints from state residents relating to any failure to protect individually identifiable health information from impermissible uses and disclosures. Additionally, many states have privacy laws that pre-empt areas of HIPAA. Consequently, businesses need to be aware of which state laws apply to their activities in addition to HIPAA.

What sort of businesses would be regulated by the FTC rather than HHS?

The sort of business that would be regulated by the FTC rather than HHS is any business that is not a HIPAA covered entity or HIPAA business associate, but that creates, receives, maintains, or transmits individually identifiable health information. Since the passage of the HITECH Act in 2009, these businesses have had to comply with the Breach Notification Rule

Typically, these businesses include the manufacturers of health apps (i.e., fitness trackers) and connected devices (wearable blood pressure cuffs) if the products offer or maintain a personal health record (PHR) collected on consumers´ behalf. Additionally, vendors of software that accesses information in a PHR or sends information to a PHR are also subject to the Breach Notification Rule.

The Security Rule has “required” and “addressable” implementation specifications. What does this mean?

The Security Rule has “required” and “addressable” implementation specifications because some implementation specifications may not be reasonable or appropriate in all circumstances. In such circumstances, an addressable implementation specification allows Covered Entities to implement an alternative measure, provided the alternative measure is at least as effective and the reason for implementing it is documented.

Why doesn´t HHS recognize HIPAA certifications?

HHS doesn’t recognize HIPAA certifications because a HIPAA certification is a “point in time” accreditation that certifies a business complies with the HIPAA requirements at the time the certificate was issued. Under §164.308, businesses are required to conduct “periodic technical and non-technical evaluations”. Consequently, a point in time accreditation does not fulfil this requirement and – as HHS notes – does not “preclude HHS from subsequently finding a security violation”.

Where can I find the full text of the Administrative Simplification Regulations?

You can find the full text of the Administrative Simplification Regulations via a PDF compiled by the Department of Health and Human Services which can be downloaded from this page on the HHS website. For businesses unfamiliar with HIPAA, please note the PDF not only includes the Privacy, Security, and Breach Notification Rules (and the changes made to them by the HITECH Act), but also Transaction, Code Set, and Identifier Standards.

What are the Administrative Simplification Regulations?

The Administrative Simplification Regulations are Parts 160, 162, and 164 of the Code of Federal Regulations relating to Public Welfare. When HIPAA was passed in 1996, Congress instructed the Secretary of Health and Human Services to develop these Parts to cover compliance investigations and civil penalties (Part 160) and the transaction code sets (Part 162).

Part 164 of the Administrative Simplification Regulations contains the Rules most Covered Entities are familiar with – the Privacy, Security, and Breach Notification Rule – although rather than being included in HIPAA at the time the first two Rules were developed, the Breach Notification Rule was added following the passage of the HITECH Act in 2009.

Why do some businesses operating in the healthcare industry not have to comply with HIPAA?

Some businesses operating in the healthcare industry do not have to comply with HIPAA because they do not qualify as HIPAA Covered Entities. This may be because they do not conduct transactions for which HHS has published standards (i.e., a counsellor that bills clients directly), or because they do not conduct the transactions electronically (i.e., claims are sent via the mail).

However, if these businesses work for a Covered Entity as a Business Associate, they are required to comply with HIPAA to the extent agreed in the Business Associate Agreement. Furthermore, even if a healthcare provider does not have to comply with HIPAA because they do not qualify as a Covered Entity, they may still have to comply with other state and federal privacy regulations.

How might some businesses already have measures in place to comply with the Privacy Rule?

Some businesses might already have measures in place to comply with the Privacy Rule if, for example, they have areas of the waiting room sectioned off so healthcare professionals can discuss diagnoses with patients and their families in private, if they already have a “minimum necessary” policy, or if they allow patients to request a copy of their medical records.

How might some businesses already have measures in place to comply with the Security Rule?

Some businesses might already have measures in place to comply with the Security Rule if, for example, they enforce a password policy that requires users to create unique and complex passwords, if they run a security and awareness training program (which includes all members of the workforce), and if they maintain on-premises servers in a secure, access-controlled environment.

Why will most businesses have processes in place to comply with the Breach Notification Rule?

Most businesses will have processes in place to comply with the Breach Notification Rule because all 50 states, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands have laws requiring private businesses, and – in most states – governmental entities to notify individuals of security breaches of information involving personally identifiable information.

Security breach laws typically have provisions regarding who must comply with the law (i.e., businesses, data or information brokers, healthcare providers, etc.), definitions of “personal information” (i.e., name combined with SSN, driver’s license or state ID, account numbers, etc.), what constitutes a breach (i.e., unauthorized acquisition of data), requirements for notice (i.e., timing or method of notice, who must be notified), and exemptions (i.e., for encrypted data).

How many states have medical privacy laws that can preempt HIPAA?

Forty-four states have medical privacy laws that can preempt HIPAA, but generally there may only be one or two clauses in the state regulations HIPAA Covered Entities have to be aware of. For example, in many states, a patient authorization is required before the patient’s HIV/AIDS status can be revealed by a healthcare provider (not required by HIPAA), or it may be the case that reports of child and elder abuse are mandatory (compared to being permitted by HIPAA).

What is a material change to policies and procedures that requires refresher HIPAA training?

A material change to policies and procedures that requires refresher HIPAA training is any change to a policy or procedure that affects the roles of members of the workforce. For example, if you change the procedures for requesting an accounting of disclosures, members of the workforce who respond to patients’ requests for an accounting of disclosures will have to be trained in the new procedures.

Is HIPAA refresher training mandatory?

HIPAA refresher training is mandatory when there is a material change to policies and procedures, but it is a best practice for Covered Entities to provide refresher training at least annually to prevent poor compliance practices creeping in. In addition, it is important to be aware that the security and awareness program required by the Security Rule is a “program” and not a one-off session. This implies security and awareness training should be ongoing and include references to HIPAA policies.

What difference does “a good faith attempt” at HIPAA compliance make following a data breach?

The difference a good faith attempt at HIPAA compliance can make following a data breach is significant. In January 2021, President Trump signed an amendment to the HITECH Act which gives HHS’ Office for Civil Rights enforcement discretion when calculating a civil monetary penalty following a data breach. Although the amendment doesn’t provide immunity from HIPAA penalties, HHS’ Office for Civil Rights has the authority to refrain from enforcing a penalty if there has been a good faith attempt to comply with HIPAA in the twelve months previous to a data breach.

Why is it in service providers’ best interests to take responsibility for their own compliance?

Since the publication of the Final Omnibus Rule in 2013, service providers operating as Business Associates have been directly liable for compliance with certain Privacy Rule and Security Rule requirements. Therefore, even though Business Associates are required to report all security incidents to the Covered Entity they are providing a service to, if it transpires that a data breach was attributable to the Business Associate’s failure to comply with the Privacy Rule and Security Rule requirements, the Business Associate – rather than the Covered Entity – will be considered liable.

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HIPAA Rules on Contingency Planning

Posted by HIPAA Journal

In its March 2018 cybersecurity newsletter, OCR explained HIPAA Rules on contingency planning and urged healthcare organizations to plan for emergencies to ensure a return to normal operations can be achieved in the shortest possible time frame.

A contingency plan is required to ensure that when disaster strikes, organizations know exactly what steps must be taken and in what order.

Contingency plans should cover all types of emergencies, such as natural disasters, fires, vandalism, system failures, cyberattacks, and ransomware incidents. The steps that must be taken for each scenario could well be different, especially in the case of cyberattacks vs. natural disasters. The plan should incorporate procedures to follow for specific types of disasters.

Contingency planning is not simply a best practice. It is a requirement of the HIPAA Security Rule. Contingency planning should not be considered a onetime checkbox item necessary for HIPAA compliance. It should be an ongoing process with plans regularly checked, updated, and tested to ensure any deficiencies are identified and addressed.

What are the HIPAA Rules on Contingency Planning?

HIPAA Rules on contingency planning are concerned with ensuring healthcare organizations return to normal operations as quickly as possible and the confidentiality, integrity, and availability of PHI is safeguarded.

HIPAA Rules on contingency planning can be found in the Security Rule administrative safeguards -45 CFR § 164.308(a)(7)(ii)(A-E).

  • Develop and Implement a Data Backup Plan – 308(a)(7)(ii)(A)
  • Develop a Disaster Recovery Plan – 308(a)(7)(ii)(B)
  • Develop and Emergency Mode Operation Plan – 308(a)(7)(ii)(C)
  • Develop and Implement Procedures for Testing and Revision of Contingency Plans – 308(a)(7)(ii)(D)
  • Perform an Application and Data Criticality Analysis – 308(a)(7)(ii)(E)

A data backup plan ensures that when disaster strikes, PHI is not lost or destroyed. A viable copy of all ePHI must be created that allows exact copies of ePHI to be restored, which includes all forms of ePHI such as medical records, diagnostic images, test results, case management information, and accounting systems.  It is a good best practice to adopt a 3-2-1 approach for backups: Create three copies of data, store them on at least two different media, and have one copy stored securely offsite. Backups must also be tested to ensure the recovery of data is possible.

A disaster recovery plan should establish the procedures that must be followed to restore access to data, including how files should be restored from backups. A copy of the plan should be readily available and stored in more than one location.

The emergency mode operation plan must ensure critical business processes continue to maintain the security of ePHI when operating in emergency mode, for example when there is a technical failure or power outage.

All elements of the contingency plan must be regularly tested and revised as necessary. OCR recommends conducting scenario-based walkthroughs and live tests of the complete plan.

Covered entities should “assess the relative criticality of specific applications and data in support of other contingency plan components.” All software applications that are used to store, maintain, or transmit ePHI must be assessed to determine the level of criticality to business functions as it will be necessary to prioritize each when data is restored.

Summary of Key Elements of Contingency Planning

OCR has provided a summary of the key elements of contingency planning:

  • The primary goal is to maintain critical operations and minimize loss.
  • Define time periods – What must be done during the first hour, day, or week?
  • Establish Plan Activation – What event(s) will cause the activation of the contingency plan?  Who has the authority to activate the contingency plan?
  • Ensure the contingency plan can be understood by all types of employees.
  • Communicate and share the plan and roles and responsibilities with the organization.
  • Establish a testing schedule for the plan to identify gaps.
  • Ensure updates for plan effectiveness and increase organizational awareness.
  • Review the plan on a regular basis and situationally when there are technical, operational, environmental, or personnel changes in the organization.

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Class Action Lawsuit Seeks Damages for Victims of CVS Caremark Data Breach

Posted by HIPAA Journal

An alleged healthcare data breach that saw the protected health information of patients of CVS Caremark exposed has resulted in legal action against CVS, Caremark, and its mailing vendor, Fiserv.

The lawsuit, which was filed in Ohio federal court on March 21, 2018, relates to an alleged privacy breach that occurred as a result of an error that affected a July/August 2017 mailing sent to approximately 6,000 patients.

In July 2017, CVS Caremark was contracted to operate as the pharmacy benefits manager for the Ohio HIV Drug Assistance Program (PhDAP), and under that program, CVS Caremark provides eligible patients with HIV medications and communicates with them about prescriptions.

In July/August 2017, CSV Caremark’s mailing vendor Fiserve sent letters to patients containing their membership cards and information about how they could obtain their HIV medications.

In the lawsuit the complaint alleges HIV-related information was clearly visible through the plastic windows of the envelopes, allowing the information to be viewed by postal service workers, family members, and roommates. It is alleged the mailing resulted in the disclosure of the recipient’s HIV status.

According to Ohio Department of Health policies, information related to HIV should only be sent in non-window envelopes. The mailing would have violated those policies and Health Information Portability and Accountability Act (HIPAA) Rules.

Such a HIPAA breach would need to be reported to the Department of Health and Human Services’ Office for Civil Rights within 60 days of discovery of the breach; however, the complainant alleges no breach report was submitted to OCR and notifications were not sent to affected individuals – A further breach of HIPAA Rules.

Plaintiffs are seeking punitive and compensatory damages and coverage of their legal costs.

There have been other breaches of HIV information in recent weeks, including a mailing error by a vendor of Aetna. In that case, HIV-related information was visible through the clear plastic windows of envelopes in a mailing to 12,000 individuals. Aetna settled a class action lawsuit filed on behalf of victims of the breach for $17,161,200 and is currently suing its mailing vendor to recover the costs. Aetna was also fined by the New York Attorney General over the breach and settled that case for $1.15 million.

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What is the Civil Penalty for Knowingly Violating HIPAA?

Posted by HIPAA Journal

What is the civil penalty for knowingly violating HIPAA Rules? What is the maximum financial penalty for a HIPAA violation and when are fines issued? In this post we answer these questions and explain about the penalties for violating HIPAA Rules

What is HIPAA?

The Health Insurance Portability and Accountability Act – HIPAA – is a federal law that applies to healthcare organizations and healthcare employees. HIPAA requires healthcare organizations to develop policies and procedures to protect the privacy of patients and implement safeguards to ensure the confidentiality, integrity, and availability of protected health information (PHI). HIPAA places restrictions on the uses of health data, who can be provides with copies of health information, and gives patients the right to obtain copies of their health data.

HIPAA covered entities are typically healthcare providers, health plans, and healthcare clearinghouses. HIPAA also applies to vendors and suppliers (business associates) that require access to PHI to perform their contracted duties.

As with other federal laws, there are penalties for noncompliance. The financial penalties for HIPAA violations can be severe, especially when HIPAA has been “knowingly” violated – When HIPAA Rules have been consciously violated with intent.

Financial Penalties for Healthcare Organizations Who Knowingly Violating HIPAA

The civil penalty tier system for healthcare organizations is based on the extent to which the HIPAA covered entity was aware that HIPAA Rules were violated. The maximum civil penalty for knowingly violating HIPAA is $50,000 per violation up to a maximum of $1.5 million per violation category.

Penalty Structure for HIPAA Violations

 

Civil penalties will be dictated by the nature and extent of the violation, the number of individual affected, and the harm that has been caused to those individuals.

Healthcare Employees May Have to Pay a Civil Penalty for Knowingly Violating HIPAA

As with healthcare organizations, healthcare employees can also be fined for violating HIPAA Rules. Civil penalties can be issued to any person who is discovered to have violated HIPAA Rules. The Office for Civil Rights can impose a penalty of $100 per violation of HIPAA when an employee was unaware that he/she was violating HIPAA Rules up to a maximum of $25,000 for repeat violations.

In cases of reasonable cause, the fine rises to $1,000 per violation with a maximum of $100,000 for repeat violations, for willful neglect of HIPAA Rules where the violation was corrected the fine is $10,000 and up to $250,000 for repeat violations and willful neglect with no correction carries a penalty of $50,000 per violation and up to $1.5 million for repeat violations.

Criminal Charges for HIPAA Violations

The Office for Civil Rights enforces HIPAA Rules in conjunction with the Department of Justice and will refer cases of possible criminal violations of HIPAA Rules to the DoJ. Directors, officers, and employees may be deemed to be criminally liable for violations of HIPAA Rules under the principle of corporate criminal liability, and if not directly liable, could be charged with aiding and abetting or conspiracy.

The penalty tiers are based on the extent to which an employee was aware that HIPAA Rules were being violated. At the lowest level, a violation of HIPAA Rules could attract a maximum penalty of $50,000 and/or up to one year imprisonment.

If HIPAA Rules are violated under false pretenses the maximum fine rises to $100,000 and/or up to 5 years imprisonment. The maximum civil penalty for knowingly violating HIPAA Rules is $250,000, such as when healthcare information is stolen with the intent to sell, transfer, or use for personal gain, commercial advantage, or malicious harm. In addition to a fine, the maximum jail term is 10 years.

In addition to the punishment provided, aggravated identity theft carries a prison term of 2 years. When PHI has been stolen and patients have been defrauded, restitution may also need to be paid.

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