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HIPAA Training for Employees

Posted by HIPAA Journal

The regulations relating to HIPAA training for employees are deliberately flexible because of the different functions Covered Entities perform, the different roles of employees, and the different level of access each employee has to Protected Health Information (PHI).

The degree of flexibility can create misunderstandings about which employees require training, what training should be provided, how training should be provided, and when training should be provided. This blog aims to clarify the regulations relating to employee training.

Which Employees Require HIPAA Training?

The first issue to resolve is straightforward. Both the HIPAA Privacy Rule (45 CFR § 164.530) and the HIPAA Security Rule (45 CFR § 164.308) stipulate training should be provided to all members of the workforce. That means not only employees, but also agency staff, consultants, and contractors regardless of the level of interaction with PHI – even if they have no contact with PHI at all.

However, whereas the HIPAA Security Rule applies to Covered Entities and Business Associates, the HIPAA Privacy Rule only applies to Covered Entities. Therefore, Business Associates only need to implement a security awareness and training program as required by the Security Rule – ensuring that all members of the workforce receive HIPAA training regardless of their role or function.

What HIPAA Training Should be Provided to Employees?

The HIPAA Privacy Rule requires each Covered Entity to develop policies and procedures designed to comply with the Rule´s standards and implementation specifications and “train all members of its workforce on the policies and procedures […] as necessary and appropriate for the members of the workforce to carry out their functions within the Covered Entity”.

This implies the content of HIPAA training will depend on what policies and procedures the Covered Entity has developed, and what policies and procedures are relevant for each employee to carry out their functions in compliance with HIPAA. As a guide, this article on the HIPAA Training Requirements includes examples of HIPAA compliance training.

How Should HIPAA Compliance Training for Employees be Provided?

Covered Entities and Business Associates have several options when it comes to providing HIPAA compliance training for employees. Historically, HIPAA compliance training was classroom- based and led by an instructor – usually the HIPAA Privacy Officer or HIPAA Security Officer. However, classroom-based training can often be ineffective because there is so much to cover in HIPAA.

For example, a classroom-based training session for patient-facing employees would have to cover areas of HIPAA such as the provision of Privacy Notices, Patients´ Rights under HIPAA, the Minimum Necessary Standard, using technologies such as EHRs compliantly, and the Breach Notification Rule. It is a lot to cover in a single training session, and a lot for employees to remember.

HIPAA Training Video for Employees

A HIPAA training video for employees can be used as part of – or as an alternative to – classroom-based training. Videos enable instructors to break down and explain HIPAA visually, which can lead to more engagement and better retention. When used as an alternative to classroom-based training, videos can also overcome the problem of getting trainees in the same place at the same time.

An unfortunate issue with HIPAA training videos for employees is that it can be impractical to produce a different video that is relevant to each employee´s role because of the expense. Therefore, while a HIPAA training video can be of some benefit – for example, for providing an explanation of PHI – it is often not the best way to comply with the HIPAA training requirements.

Online HIPAA Training for Employees

Online HIPAA training for employees comprised of mix-and-match modules is a far more effective way for Covered Entities and Business Associates to comply with the HIPAA training requirements. The modules can be assembled into groups to be relevant to each employee´s role – or employee group roles – and each employee can complete the training individually in their own time.

Online training not only makes it easier for a Covered Entity or Business Associate to provide initial training (i.e., when onboarding new employees), but also makes it easier to provide refresher training or HIPAA-mandated training whenever “functions are affected by a material change in the policies or procedures”, as individual modules are easier to update than complete training courses.

When Should HIPAA Training for Employees be Provided?

Covered Entities are required to provide training on HIPAA policies and procedures “within a reasonable period of time after a person joins the Covered Entity´s workforce” and whenever “functions are affected by a material change in the policies or procedures”. There is no time period stipulated for when a security awareness and training program has to be provided.

In addition, Covered Entities and Business Associates should incorporate HIPAA training for employees into risk analyses. This will help identify when further training is needed by members of the workforce to prevent unauthorized uses or disclosures of PHI that have developed through bad practices. If a need for training is identified, it must be provided “within a reasonable period”.

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HIPAA Privacy Rule Changes Proposed to Improve Care Coordination and Patient Rights

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The Department of Health and Human Services has issued a notice of proposed rulemaking detailing multiple HIPAA Privacy Rule changes that are intended to remove regulatory burdens, improve care coordination, and give patients better access to their protected health information (PHI).

OCR issued a request for public input on potential HIPAA Privacy Rule changes in December 2018 under the HHS’ Regulatory Sprint to Coordinated Care. The regulatory sprint was intended to accelerate transformation of the healthcare system and remove some of the barriers that have hampered the coordination of care, were making it difficult for healthcare providers to share patient information and placed an unnecessary burden on patients and their families who were trying to get their health information exchanged. In response to the request for information, the HHS received around 1,300 comments spanning 4,000 pages. The HHS has had to strike a balance between providing more flexibility to allow health information to be shared easily and ensuring the privacy and security of healthcare data.

“Our proposed changes to the HIPAA Privacy Rule will break down barriers that have stood in the way of commonsense care coordination and value-based arrangements for far too long,” said HHS Secretary Alex Azar. “As part of our broader efforts to reform regulations that impede care coordination, these proposed reforms will reduce burdens on providers and empower patients and their families to secure better health.”

HIPAA was initially signed into law in 1996 and the Privacy Rule took effect in 2003, prior to widespread adoption of electronic medical records and before many online and mobile services were available. The proposed updates are intended to remove some of the barriers to digital health, with definitions added for terms such as electronic health records and personal health applications.

Strengthening Patients’ Rights to their Own Healthcare Data

The HIPAA Privacy Rule gave patients the right to access their own healthcare data. The proposed changes will see those rights strengthened with regard to electronic protected health information (ePHI) and inspecting PHI in person. Individuals will be permitted to take notes and use personal resources to view and capture images of their own PHI, such as taking photographs of their own medical records and medical images. The time frame for providing patients with access to their own PHI has been shortened from 30 days to 15 days from the date of request and the identity verification burden on individuals has been eased.

Disclosures to Telecommunication Relay Services (TRS), which are used by the deaf and hard of hearing, are expressly permitted and TRS providers have been excluded from the definition of business associate.

The HHS has specified when ePHI must be provided to individuals at no cost – such as when ePHI is provided through online patient portals – and the permissible fee structure has been amended for responding to requests to direct healthcare records to a third party.

The HHS has also created a pathway for individuals to direct the sharing of ePHI in an EHR among covered health care providers and health plans. Covered entities will also be required to publish estimated fee structures on their websites for providing access to PHI and copies of PHI, as well as provide individuals with itemized bills for completed requests.

Improving Coordination of Care and Reducing the Administrative Burden

Several changes have been proposed to improve information sharing for care coordination and case management for individuals, which will make it easier for hospitals and physician practices to share patient information with other healthcare providers and social service and caregiving agencies.

If patients give their authorization for their healthcare provider or doctor to see their medical records from another healthcare provider, it will be the healthcare provider or doctor’s office that will be responsible for getting that information rather than the patient.

The privacy standard that permitted covered entities to make disclosures based on their professional judgement has been changed to permit uses and disclosures based on a covered entity’s good faith belief that a use or disclosure is in the best interests of the patient, which is more permissive.

Changes have also been proposed to remove the administrative burden on healthcare providers, such as long-awaited removal of the requirement to have patients sign a notice of privacy practices, instead they will only need to be provided with a notice of privacy practices. This change alone is expected to save the healthcare industry an estimated $3.2 billion over five years.

Changes have been proposed to improve the sharing of healthcare data in crises and emergencies. Currently, the HIPAA Privacy Rule permits covered entities to disclose patient health information to avert a serious and imminent threat to health or patient safety. The wording has been changed to avert threats when harm is ‘serious and reasonably foreseeable’. The change would make it easier for healthcare providers to share information when individuals have stated they are contemplating suicide, for instance, and would improve care coordination in emergencies such as the opioid and COVID-19 public health emergencies.

Commonsense, Bipartisan HIPAA Privacy Rules Changes

“Today’s announcement is a continuation of our ongoing work under my Regulatory Sprint to Coordinated Care to eliminate unnecessary regulatory barriers blocking patients from getting better care,” said HHS Deputy Secretary Eric Hargan. “These proposed changes reduce burden on providers and support new ways for them to innovate and coordinate care on behalf of patients, while ensuring that we uphold HIPAA’s promise of privacy and security.”

The HHS is accepting comments from all healthcare industry stakeholders, including patients and their families, healthcare providers, health plans, business associates, health IT vendors and government entities. Comments must be submitted within 60 days of the publication of the notice of proposed rulemaking in the Federal Register.

With President-Elect Biden due to take office in January, it is likely there will be significant amendments to the proposed HIPAA Privacy Rule changes; however, many of the updates have been proposed to address issues that have been proving problematic for hospitals, doctors, and patients for many years and are non-partisan, commonsense changes. HHS officials hope the incoming administration will understand the need for these HIPAA Privacy Rule changes and will provide the support to ensure they are implemented.

You can view the proposed 2020 HIPAA Privacy Rule changes on this link (PDF).

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HHS Increases Civil Monetary Penalties for HIPAA Violations in Line with Inflation

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The U.S Department of Health and Human Services’ has increased the civil monetary penalties for HIPAA violations to take inflation into account, in accordance with the Inflation Adjustment Act.

The final rule was issued and took effect on Tuesday November 5, 2019. This rule increases the civil monetary penalties for HIPAA violations that occurred on or after February 18, 2019. Under the new penalty structure, the increases from 2018 to 2019 are detailed in the table below:

Penalty Tier Level of Culpability Minimum Penalty per Violation

(2018 » 2019)

 Maximum Penalty per Violation

(2018 » 2019)

 New Maximum Annual Penalty

(2018 » 2019)*
1 No Knowledge $114.29 » $117 $57,051 » $58,490 $1,711,533 » $1,754,698
2 Reasonable Cause $1,141 » $1,170 $57,051 » $58,490 $1,711,533 » $1,754,698
3 Willful Neglect – Corrective Action Taken $11,410 » $11,698 $57,051 » $58,490 $1,711,533 » $1,754,698
4 Willful Neglect – No Corrective Action Taken $57,051 » $58,490 $1,711,533 » $1,754,698 $1,711,533 » $1,754,698

Penalties for HIPAA violations that occurred prior to February 18, 2019 have increased to $159 per violation, with an annual cap of $39,936 per violation category.

Earlier this year, the HHS’ Office for Civil Rights announced that it had reduced the penalties for HIPAA violations in certain tiers after a review of the wording of the HITECH Act. The maximum penalty for a HIPAA violation in the highest tier remained at $1.711 million, per violation category per year. Prior to the review, the maximum HIPAA violation penalty was $1.711 million in all four penalty tiers.

*The notice of enforcement discretion, announced on April 30, 2019, capped the maximum annual penalties at $10,000 (Tier 1), $100,000 (Tier 2), $250,000 (Tier 3), and $1,711,533 (Tier 4). The notice of enforcement discretion stated that the reviewed penalty tiers would also be adjusted in line with inflation. The multiplier used by OCR to calculate the cost-of-living increases was based on the Consumer Price Index for all Urban Consumers (CPI–U) for October 2019, which was 1.02522. That would make the new maximum penalties under the notice of enforcement discretion $10,252.20 (Tier 1), $102,522 (Tier 2), $256,305 (Tier 3), and $1,754,698 (Tier 4).

While OCR’s notice of enforcement discretion states that OCR will be adopting the new, revised penalties, this has yet to be made official and is pending further rulemaking. The notification of enforcement discretion creates no legal obligations and no legal rights, so OCR could therefore legally use the above maximum penalty amount of $1,754,698 per violation category, per year across all penalty tiers.

Full details of the new penalty structures have been published in the Federal Register for all agencies, including the FDA, ACF, HRSA, AHRQ, OIG, CMS, and OCR and can be viewed here (PDF).

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Texas Health and Human Services Commission Pays $1.6 Million HIPAA Penalty

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The Department of Health and Human Services’ Office for Civil Rights (OCR) has imposed a $1.6 million civil monetary penalty (CMP) on Texas Health and Human Services Commission (TX HHSC) for multiple violations of Health Insurance Portability and Accountability Act (HIPAA) Rules.

TX HHSC is a state agency that operates supported living centers, regulates nursing and childcare facilities, provides mental health and substance abuse services, and administers hundreds of state programs for people in need of assistance, such as individuals with intellectual and physical disabilities.

OCR launched an investigation following receipt of a breach report from the Department of Aging and Disability Services (DADS), a state agency that was reorganized into TX HHSC in September 2017. On June 11, 2015, DADS reported a security incident to OCR which stated that the electronic protected health information (ePHI) of 6,617 individuals had been exposed over the internet. The exposed information included names, addresses, diagnoses, treatment information, Medicaid numbers, and Social Security numbers.

The information was exposed during the migration of an internal CLASS/DBMD application from a private server to a public server. A flaw in the software of the application allowed ePHI to be accessed over the internet without any authentication. As a result of the flaw, private and highly sensitive information could be found and accessed through a Google search.

TX HHSC was unable to provide documentation to demonstrate compliance with three important provisions of HIPAA Rules. OCR determined that TX HHSC had violated four HIPAA provisions.

  • 45 C.F.R. § 164.308(a)(1 )(ii)(A) – Failure to conduct a comprehensive organization-wide risk analysis to identify all risks to the confidentiality, integrity, and availability of PHI
  • 45 C.F.R. § 164.312(a)(1) – Failure to implement access controls. Credentials were not required to access ePHI contained in its CLASS/DBMD
  • 45 C.F.R. § 164.312(b) – Failure to implement audit controls that recorded user access on the public server, which prevented TX HHSC from determining who had accessed ePHI in the application during the time it was exposed.
  • 45 C.F.R. § 164.502(a) – The above failures resulted in an impermissible disclosure of the ePHI of 6,617 individuals.

Under HIPAA, financial penalties are determined based on the level of culpability. OCR determined that the violations fell short of willful neglect and constituted reasonable cause – the second penalty tier. For each of the above classes of HIPAA violation, the minimum penalty for a violation is $1,000 up to a maximum financial penalty of $100,000 per year. The risk analysis failures, access controls failures, and audit control failures spanned from 2013 to 2017, hence the $1.6 million penalty.

“Covered entities need to know who can access protected health information in their custody at all times,” said OCR Director Roger Severino. “No one should have to worry about their private health information being discoverable through a Google search.”

We initially reported on the HIPAA penalty in March 2019 when it appeared that a settlement had been reached between TX HHSC and OCR over the HIPAA violations. The 86th Legislature of the State of Texas had voted to approve the settlement; however, it would appear that the proposed settlement was rejected. OCR issued a Notice of Proposed Determination on July 29, 2019.

TX HHSC did not contest the findings of OCR’s Notice of Proposed Determination and waived the right to a hearing. OCR imposed the CMP on TX HHSC on October 25, 2019.

This is the second HIPAA penalty to be announced by OCR this week. A few days ago, OCR announced a $3 million settlement had been reached with the University of Rochester Medical Center to resolve HIPAA violations related to the loss of unencrypted devices containing ePHI.

The TX HHSC CMP is the seventh HIPAA penalty of 2019. The latest CMP brings the total HIPAA fines for 2019 up to $9,949,000.

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Lack of Encryption Leads to $3 Million HIPAA Penalty for New York Medical Center

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The University of Rochester Medical Center (URMC) has paid a $3 million HIPAA penalty for the failure to encrypt mobile devices and other HIPAA violations.

URMC is one of the largest health systems in New York State with more than 26,000 employees at the Medical Center and various other components of the health system, including Strong Memorial Hospital and the School of Dentistry.

The Department of Health and Human Services’ Office for Civil Rights (OCR) launched an investigation following receipt of two breach reports from UMRC – The loss of an unencrypted flash drive and the theft of an unencrypted laptop computer in 2013 and 2017.

This was not the first time OCR had investigated URMC. An investigation was launched in 2010 following a similar breach involving a lost flash drive. In that instance, OCR provided technical compliance assistance to URMC. The latest investigation uncovered multiple violations of HIPAA Rules, including areas of noncompliance that should have been addressed after receiving technical assistance from OCR in 2010.

Under HIPAA, data encryption is not mandatory. Following a risk analysis, as part of the risk management process, covered entities must assess whether encryption is an appropriate safeguard. An alternative safeguard can be implemented in place of encryption if it provides an equivalent level of protection.

In this case, URMC had assessed risk and determined that the lack of encryption posed a high risk to the confidentiality, integrity, and availability of ePHI, yet failed to implement encryption when it was appropriate and continued to use unencrypted mobile devices that contained ePHI, in violation of 45 C.F.R. § 164.31 2(a)(2)(iv).

OCR’s investigation confirmed that the ePHI of 43 patients was contained on the stolen laptop and as a result of the theft, that information was impermissibly disclosed – 45 C.F.R. §164.502(a). OCR also determined that URMC had failed to conduct a comprehensive, organization-wide risk analysis – 45 C.F.R. § 164.308(a)(1)(ii)(A) – that included all risks to the confidentiality, integrity, and availability of ePHI, and covered ePHI stored on the lost and stolen devices.

Risks had not been sufficiently managed and reduced to reasonable and acceptable level – 45 C.F.R. §164.308(a)(l)(ii)(B) – and policies and procedures governing the receipt and removal of hardware and electronic media in and out of its facilities had not been implemented – 45 C.F.R. § 163.310(d).

In addition to the $3,000,000 financial penalty, URMC is required to adopt a robust corrective action plan to address all aspects of noncompliance identified by OCR. URMC’s compliance efforts over the next two years will be scrutinized by OCR to ensure continuing compliance.

“Because theft and loss are constant threats, failing to encrypt mobile devices needlessly puts patient health information at risk,” said OCR Director Roger Severino. “When covered entities are warned of their deficiencies, but fail to fix the problem, they will be held fully responsible for their neglect.”

This is the sixth financial penalty of 2019 that OCR has issued to resolve violations of the Health Insurance Portability and Accountability Act and it is the fourth enforcement action to cite a risk analysis failure.

The risk analysis is one of the most important elements of HIPAA compliance and a risk analysis failure is the most common HIPAA violation cited in OCRs enforcement actions.

OCR has released a risk assessment tool to help covered entities and business associates comply with this aspect of HIPAA. Further information on the HHS risk assessment tool is available on this page.

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Roger Severino Gives Update on OCR HIPAA Enforcement Priorities

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Roger Severino, Director of the HHS’ Office for Civil Rights, has given an update on OCR’s HIPAA enforcement priorities at the OCR/NIST 11th Annual HIPAA Conference in Washington D.C.

Severino confirmed that one of OCR’s top policy initiatives is still enforcing the rights of patients under the HIPAA Privacy Rule and ensuring they are given timely access to their health information at a reasonable cost.

Under HIPAA, patients have the right to view and check their medical records and obtain a copy of their health data, yet there are still healthcare organizations that are making this difficult. OCR has already agreed to settle one case this year with a HIPAA-covered entity that failed to provide a patient with a copy of her health information. OCR had to intervene before those records were provided to the patient. The entity in question, Bayfront Health St Petersburg, paid a financial penalty of $85,000 to resolve the HIPAA violation.

More financial penalties will be issued to covered entities that fail to comply with this important provision of HIPAA. Severino confirmed that Bayfront Health’s financial penalty was the first in a series of penalties for covered entities that are not providing patients with access to their health data within 30 days of the request being received.

OCR has issued guidance to help covered entities comply with this aspect of HIPAA, but now the time has come “for serious enforcement,” explained Severino.

Severino also explained that patients must be allowed to have their health data sent to health apps. The requests should only be denied if the app poses a security risk to the covered entity. Severino confirmed a covered entity is not liable for what happens to PHI after a disclosure to a health app at the patient’s request.

In many cases, patients are not being denied access to their medical records and requests for copies of medical records are being honored, but patients are being charged excessive amounts. In 2016, OCR issued guidance on the amounts that healthcare organizations can charge for providing copies of medical records and further clarification was also issued on the fee structures that can be adopted. Financial penalties for overcharging for copies of medical records can be expected.

The crackdown on patient access issues is part of the HHS Regulatory Sprint to Coordinated Care initiative and fits in with the Trump Administration’s drive to improve transparency of healthcare costs and the reduction of the cost of healthcare in the United States.

A prop is always useful for getting a point across. In this case Severino used a medical boot that he purchased to aid recovery from a torn Achilles tendon. Severino said he was advised by his doctor to purchase the boot and paid his doctor $430 for the treatment aid. He explained that he later looked online and found the exact same boot for sale on Amazon for $70, saying “This boot represents what’s wrong with price transparency.”

OCR is looking at how HIPAA can be updated to address this problem, such as requiring healthcare providers and health plans to provide information about the expected out-of-pocket costs for medical services or equipment before those items or services are provided to patients.

Contractors provide quotes for work in advance and banks provide customers with information on the costs of mortgages before providing the funds, but that doesn’t always happen in healthcare. That is something that needs to change.

Severino also touched on the issue of cybersecurity. Phishing and ransomware attacks cause a high percentage of healthcare data breaches and in many cases the attacks can be prevented by practicing good cybersecurity hygiene.

Ransomware is often installed through the exploitation of vulnerabilities in Remote Desktop Protocol. The failure to address those RDP vulnerabilities has led to several major healthcare ransomware attacks and data breaches.

Phishing attacks have been a major cause of healthcare data breaches for several years. It is not possible to prevent all attacks, but by complying with HIPAA, risk can be significantly reduced. HIPAA calls for covered entities to provide employees with training to help them identify and avoid phishing threats. Severino explained that training is critical, as is conducting phishing simulation exercises to find out how susceptible employees are to phishing.

Other cybersecurity failures that could prevent data breaches include the lack of multi-factor authentication, poor access controls, and the failure to promptly terminate access to systems when employees leave the company.

2019 may have only seen four OCR financial penalties issued to date to resolve HIPAA violations but the year is far from over. Further penalties will be announced this year, including one $2.1 million civil monetary penalty.

Severino did not confirm the reason for the penalty or provide any details, other than saying a final determination has been reached and the penalty will be announced by the department soon.

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Dental Practice Fined $10,000 for PHI Disclosures on Yelp

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The Department of Health and Human Services’ Office for Civil Rights has agreed to settle a HIPAA violation case with Elite Dental Associates over the impermissible disclosure of multiple patients’ protected health information (PHI) when responding to patient reviews on the Yelp review website.

Elite Dental Associates is a Dallas, TX-based privately-owned dental practice that provides general, implant and cosmetic dentistry. On June 5, 2016, OCR received a complaint from an Elite patient about a social media HIPAA violation. The patient claimed the dental practice had responded to a review she left on Yelp and publicly disclosed some of the PHI.

When replying to the patient’s June 4, 2016 post, Elite disclosed the patient’s last name along with details of her health condition, treatment plan, insurance, and cost information.

The investigation confirmed that to be the case, but also found it was not the first time that PHI had been disclosed without authorization on the social media platform when responding to patient reviews. Further impermissible PHI disclosures were found on the Elite review page.

In addition to the impermissible disclosures of PHI, which violated 45 C.F.R. § 164.502(a), OCR determined Elite had not implemented policies and procedures relating to PHI, in particular the release of PHI on social media and other public platforms, in violation of 45 C.F.R. § 164.530(i). Elite was also discovered not to have included the minimum required content in its Notice of Privacy Practices as required by the HIPAA Privacy Rule (45 C.F.R. § 164.520(b)).

OCR agreed to a HIPAA violation fine of $10,000 and a corrective action plan (CAP) to resolve the alleged HIPAA violations and settle the case with no admission of liability. The three potential HIPAA violations could have attracted a substantially higher financial penalty; however, when considering an appropriate financial penalty, OCR took the financial position of the practice, its size, and Elite’s cooperation with the OCR investigation into account.

“Social media is not the place for providers to discuss a patient’s care,” said OCR Director, Roger Severino.  “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

This is the 4th OCR HIPAA settlement of 2019. In September, OCR fined Bayfront Health St Petersburg $85,000 for a HIPAA Right of Access failure. In May, two settlements were agreed to resolve multiple HIPAA violations at Medical Informatics Engineering ($100,000) and Touchstone Medical Imaging ($3,000,000).

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Senate Fails to Remove Ban on Funding of National Patient Identifier

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The Department of Health and Human Services (HHS) is prohibited from using any of its budget to fund the development and implementation of a national patient identifier, but there was hope that the ban would finally be lifted this year.

The House of Representatives added an amendment to its Departments of Labor, Health, and Human Services, and Education, and Related Agencies Act of 2020 which removed the ban, which would allow the HHS to follow through on this requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

It now looks likely that the ban will remain in place for at least another year as the Senate Appropriations Subcommittee’s draft 2020 fiscal budget bill, released last Wednesday, has retained the text banning the HHS from acting on this HIPAA requirement.

The ban has been in place since 1999 and was introduced because of concerns over patient privacy. The ban has been written into the Congressional budget every year since and the proposed 2020 fiscal budget bill is no different.

The proposed fiscal budget bill includes the text, “None of the funds made available in this act may be used to promulgate or adopt any final standard under section 1173(b) of the Social Security Act providing for, or providing for the assignment of, a unique health identifier for an individual (except in an individual’s capacity as an employer or a health care provider), until legislation is enacted specifically approving the 13 standard.”

The purpose of the national patient identifier is to make it easier for patients to be efficiently matched with their health records. Regardless of where a patient receives treatment, their health data will be tied to them through their unique national patient identifier code. The new identifier would help to ensure that patient information could flow freely between different healthcare organizations and it is seen by many healthcare industry stakeholders to be essential for full interoperability. A national patient identifier could help to improve patient privacy, patient safety, and eliminate considerable waste and misspending in healthcare.

For several years, industry associations such as the College of Healthcare Information Management Executives (CHIME), the American Health Information Management Association (AHMIA), and the Health Innovation Alliance (HIA) have been calling for the ban to be lifted.

HIA Executive Director Joel White has called the ban ‘antiquated’ and said studies have suggested that patients are matched with their records as little as 50% of the time. A national patient identifier would instantly solve that problem.

Efforts to have the ban removed have stepped up in recent years, and this year 56 healthcare stakeholder groups urged the Senate to remove the ban. Significant progress was made this year when the amendment receives strong bipartisan support in the House of Representatives.

Convincing the Senate to lift the ban is proving more difficult. As long as privacy concerns remain, the ban is unlikely to be lifted. One of the main issues is a single identifier would be used to tie medical records to an individual from birth until death, and that could allow unprecedented tracking of Americans through their health records. It could also potentially facilitate the sharing, use, and analysis of patient data without patient consent.

While the draft fiscal budget bill has not had the ban removed, it is possible that an amendment could be made at a later date. AHMIA and CHIME leaders remain hopeful that the Senate will follow the House’s lead and have the ban lifted this year.

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OCR Settles First HIPAA Violation Case Under 2019 Right of Access Initiative

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Earlier this year, the Department of Health and Human Services’ Office for Civil Rights (OCR) announced that one of the main areas of HIPAA enforcement in 2019 would be HIPAA right of access failures, including untimely responses to access requests and overcharging for copies of medical records.

The HIPAA right of access allows patients to obtain copies of their medical records on request. HIPAA-covered entities are required to honor those requests and provide patients with access to PHI or copies of health data contained in a ‘designated record set’ within 30 days of the request being received. A covered entity is permitted to charge a reasonable, cost-based fee for providing a copy of the individual’s PHI, which can include the cost of certain labor, supplies and postage.

HIPAA-covered entities that fail to provide copies of records in a reasonable time frame or charge excessive amounts for providing a copy of a patient’s PHI are in violation of the HIPAA Privacy Rule – See 45 CFR 164.501. Such violations can attract a sizable financial penalty.

This week, OCR has announced that the first settlement has been reached with a HIPAA-covered entity under the right of access initiative. Bayfront Health St. Petersburg, a 480-bed hospital in St. Petersburg, FL, has agreed to pay OCR $85,000 to settle the case.

OCR launched an investigation into a potential HIPAA violation at Bayfront Health following receipt of a complaint from a patient on August 14, 2018. The patient alleged that she had requested her fetal heart monitor records from Bayfront Health St. Petersburg in October 2017. At the time of the complaint, 9 months after the request was made, she had still not been provided with a full copy of her records.

OCR confirmed that the patient made the request on October 18, 2017 and was informed by Bayfront Health that the records could not be found. Two further requests were sent to Bayfront Health by the patient’s counsel on January 2, 2018 and February 12, 2018. In March 2018, Bayfront Health provided an incomplete set of records and a complete response was only received on August 23, 2018. The patient’s counsel shared the records with the patient, but it took the intervention of OCR for the fetal heart monitor records to be provided to the patient. Those records were provided directly to the patient on February 7, 2019.

OCR determined that the failure to provide access to the patient’s designated record set was a clear violation of 45 C.F.R. § 164.524 and that the HIPAA violation warranted a sizable financial penalty.

“Providing patients with their health information not only lowers costs and leads to better health outcomes, it’s the law,” said OCR Director Roger Severino.  “We aim to hold the health care industry accountable for ignoring peoples’ rights to access their medical records and those of their kids.”

In addition to the financial penalty, Bayfront Health has agreed to implement a corrective action plan and will be monitored by OCR for the following 12 months.

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