HIPAA Compliance News

Smartwatch Data Act Introduced to Improve Privacy Protections for Consumer Health Data

Posted by HIPAA Journal

The Stop Marketing And Revealing The Wearables And Trackers Consumer Health (Smartwatch) Data Act, has been introduced by Sens. Bill Cassidy, M.D., (R-Louisiana) and Jacky Rosen, (D-Nevada). The new legislation will ensure that health data collected through fitness trackers, smartwatches, and health apps cannot be sold or shared without consumer consent.

The Health Insurance Portability and Accountability Act (HIPAA) applies to health data collected, received, stored, maintained, or transmitted by HIPAA-covered entities and their business associates. Some of the same information is collected, stored, and transmitted by fitness trackers, wearable devices, and health apps. That information can be used, shared, or sold, without consent. Consumers have no control over who can access their health data. The new legislation aims to address that privacy gap.

The bill prohibits the transfer, sale, sharing, or access to any non-anonymized consumer health information or other individually identifiable health information that is collected, recorded, or derived from personal consumer devices to domestic information brokers, other domestic entities, or entities based outside the United States unless consent has been obtained from the consumer.

Consumer devices are defined as “equipment, application software, or mechanism that has the primary function or capability to collect, store, or transmit consumer health information.”

The Smartwatch Data Act applies to information about the health status of an individual, personal biometric information, and kinesthetic information collected directly through sensors or inputted manually into apps by consumers. The Smartwatch Data Act would treat all health data collected through apps, wearable devices, and trackers as protected health information.

There have been calls for HIPAA to be extended to cover app developers and wearable device manufacturers that collect, store, maintain, process, or transmit consumer health information. The Smartwatch Data Act does not extend HIPAA to cover these companies, instead the legislation applies to the data itself. The bill proposes the HHS’ Office for Civil Rights, the main enforcer of compliance with HIPAA, would also be responsible for enforcing compliance with the Smartwatch Data Act. The penalties for noncompliance with the Smartwatch Data Act would be the same as the penalties for HIPAA violations.

“The introduction of technology to our healthcare system in the form of apps and wearable health devices has brought up a number of important questions regarding data collection and privacy,” said Sen. Rosen “This commonsense, bipartisan legislation will extend existing health care privacy protections to personal health data collected by apps and wearables, preventing this data from being sold or used commercially without the consumer’s consent.”

The legislation was introduced following the news that Google has partnered with Ascension, the second largest healthcare provider in the United States, and has been given access to the health information of 50 million Americans. That partnership has raised a number of questions about the privacy of health information.

The Ascension data passed to Google is covered by HIPAA, but currently fitness tracker data is not. Google intends to acquire fitness tracker manufacturer Fitbit in 2020 and concern has been raised about how Google will use personal health data collected through Fitbit devices. The Smartwatch Data Act would help to ensure that consumers are given a say in how their health data is used.

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House Committee Leaders Demand Answers from Google and Ascension on Project Nightingale Partnership

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Leaders of the House Committee on Energy and Commerce are seeking answers from Google and Ascension on Project Nightingale. The Department of Health and Human Services’ Office for Civil Rights has also confirmed that an investigation has been launched to determine if HIPAA Rules have been followed.

The collaboration between Google and Ascension was revealed to the public last week. The Wall Street Journal reported that Ascension was transferring millions of patient health records to Google as part of an initiative called Project Nightingale.

A whistleblower at Google had contacted the WSJ to raise concerns about patient privacy. A variety of internal documents were shared with reporters on the extent of the partnership and the number of Google employees who had access to Ascension patients’ data. Under the partnership, the records of approximately 50 million patients will be provided to Google, 10 million of which have already been transferred.

According to the WSJ report, 150 Google employees are involved with the project and have access to patient data. The whistleblower stated that those individuals are able to access and download sensitive patient information and that patients had not been informed about the transfer of their data in advance. Understandably, the partnership has raised concerns about patient privacy.

Both Google and Ascension released statements about the partnership after the WSJ story was published, confirming that Google was acting as a business associate of Ascension, had signed a business associate agreement, and that it was in full compliance with HIPAA regulations. Under the terms of the BAA, which has not been made public, Google is permitted access to patient data in order to perform services on behalf of Ascension for the purpose of treatment, payment, and healthcare operations.

Google will be analyzing patient data and using its artificial intelligence and machine learning systems to develop tools to assist with the development of patient treatment plans. Google will also be helping Ascension modernize its infrastructure, electronic health record system, and improve collaboration and communication. Google has confirmed in a blog post that it is only permitted to use patient data for purposes outlined in the BAA and has stated that it will not be combining patient data with any consumer data it holds and that patient data will not be used for advertising purposes.

Democratic leaders of the House Committee on Energy and Commerce wrote to Google and Ascension on November 18, 2019 requesting further information on the partnership. The inquiry is being led by House Energy Committee Chairman, Frank Pallone Jr. (D-New Jersey). The letters have also been signed by Chairwoman of the Subcommittee on Health, Anna Eshoo (D-California), Subcommittee on Consumer Protection and Commerce Chair, Jan Schakowsky (D-Illinois), and Subcommittee on Oversight and Investigations Chair, Diana DeGette (D-Colorado).

In the letters, the Committee leaders have requested information on the “disturbing initiative” known as Project Nightingale.

“While we appreciate your efforts to provide the public with further information about Project Nightingale, this initiative raises serious privacy concerns. For example, longstanding questions related to Google’s commitment to protecting the privacy of its own users’ data raise serious concerns about whether Google can be a good steward of patients’ protected health information.”

Ascension’s decision not to inform patients prior to the transfer of protected health information has also raised privacy concerns, as has the number of Google employees given access to the data. Further, employees of Google’s parent company Alphabet also have access to Ascension data.

The Committee leaders have requested a briefing by no later than December 6, 2019 about the types of data being used, including the data being fed into its artificial intelligence tools, and the extent to which Google and Alphabet employees have access to the data. The Committee leaders also want to know what steps have been taken to protect patient information and the extent to which patients have been informed.

The Department of Health and Human Services’ Office for Civil Rights has also confirmed that it has launched an investigation into the partnership. Its investigation is primarily focused on how data is being transferred, the protections put in place to safeguard the confidentiality, integrity, and availability of protected health information, and whether HIPAA Rules are being followed. Google has stated it will be cooperating fully with the OCR investigation.

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Update Issued on Unsecured PACS as Exposed Medical Image Total Rises to 1.19 Billion

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It has been 60 days since Greenbone Networks uncovered the extent to which medical images in Picture Archiving and Communication Systems (PACS) servers are being exposed online. In an updated report, the German vulnerability analysis and management platform provider has revealed the problem is getting worse, not better.

Picture Archiving and Communication Systems (PACS) servers are extensively used by healthcare providers for archiving medical images and sharing those images with physicians for review, yet many healthcare providers are not ensuring their PACS servers have appropriate security. Consequently, medical images (X-Ray, MRI, CT Scans), along with personally identifiable patient information, is being exposed over the Internet. Anyone who knows where to look and how to search for the files can find them, view them and, in many cases, download the images without any authentication required. The images are not accessible due to software vulnerabilities. Data access is possible because of the misconfiguration of infrastructure and PACS servers.

Between July and September 2019, Greenbone Networks conducted an analysis to identify unsecured PACS servers around the globe. The study shed light on the scale of the problem. In the United States, 13.7 million data sets were found on unsecured PACS servers, which included 303.1 million medical images of which 45.8 million were accessible. The discovery was widely reported in the media at the time, and now further information on the scale of the problem has been released.

On Monday, November 18, Greenbone Networks issued an updated report that shows globally, 1.19 billion medical images have now been identified, increasing the previous total of 737 million by 60%. The results of 35 million medical examinations are online, up from 24 million.

In the United States, the researchers found 21.8 million medical examinations and 786 million medical images. 114.5 of those images were accessible and there are 15 systems that allow unprotected Web/FTP access and directory listing. In one PACS alone, the researchers found 1.2 million examinations and 61 million medical images. The researchers had full access to the data, which included the images and associated personally identifiable information. Greenbone Networks has confirmed that in the 24 hours prior to publication of its latest report, data access was still possible. “For most of the systems we scrutinized, we had – and still have – continued access to the personal health information,” explained Greenbone Networks CMS, Dirk Schrader.

Exposed Medical Images on PACS Servers. Source: Greenbone Networks

Earlier in November, Sen. Mark. R. Warner wrote to HHS’ Office for Civil Rights Director, Roger Severino, expressing concern over the apparent lack of action from OCR over the exposed files. Far from the situation improving following the announcement about the exposed data, it appears that very little is being done to secure the PACS servers and stop further data exposure.

The types of information in the images, which is classed as Protected Health Information (PHI) under HIPAA, includes names, dates of birth, examination dates, scope of the investigations, imaging procedures performed, attending physicians’ names, location of scan, number of images and, for 75% of the images, Social Security numbers.

The exposure of this data places patients at risk of identity theft and fraud, although there are other risks. Previously, security researchers have shown that flaws in the DICOM image format allows the insertion of malicious code. Images could therefore be downloaded, have malicious code inserted, and be uploaded back to the PACS. This could all be down without the knowledge of the data owner. For the purpose of the study, Greenbone Networks only investigated reading access, not image manipulation and upload.

Images were accessed and viewed using the RadiAnt DICOM Viewer. Instructions on configuration to view images using the RadiAnt DICOM Viewer are freely available online, as is the viewer and the list of IPs where the images are stored.

Greenbone Networks estimates that the exposed medical images and PHI has a value in excess of $1 billion dollars. The data could be used for a variety of nefarious purposes including identity theft, social engineering and phishing, and blackmail.

The exposure of the data is in violation of the Health Insurance Portability and Accountability Act (HIPAA), the EU’ s General Data Protection Regulation (GDPR), and many other data privacy and security laws. The data relates to more individuals in more than 52 countries.

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TigerConnect Survey Finds 89% of Healthcare Providers Still Use Fax Machines and 39% are Still Using Pagers

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TigerConnect has released its 2019 State of Healthcare Communications Report, which shows that continuing reliance on decades-old, inefficient communications technology is negatively impacting patients and is contributing to the increasing cost of healthcare provision.

For the report, TigerConnect surveyed more than 2,000 patients and 200 healthcare employees to assess the current state of communications in healthcare and gain insights into areas where communication inefficiencies are causing problems.

The responses clearly show that communication in healthcare is broken. 52% of healthcare organizations are experiencing communication disconnects that impact patients on a daily basis or several times a week. Those communication inefficiencies are proving frustrating for healthcare employees and patients alike.

The report reveals most hospitals are still heavily reliant on communications technology from the 1970s. 89% of hospitals still use faxes and 39% are still using pagers in some departments, roles, or even across the entire organization. The world may have moved on, but healthcare hasn’t, even though healthcare is the industry that stands to benefit most from the adoption of mobile technology.

The HHS’ Centers for Medicaid and Medicare Services (CMS) is pushing for fax machines to be eliminated by the end of 2020 and for healthcare organizations to instead use more secure, reliable, and efficient communications methods. Given the extensive use of fax machines, that target may be difficult to achieve.

“Adoption of modern communication solutions has occurred in every other industry but healthcare,” said Brad Brooks, chief executive officer and co-founder of TigerConnect. “Despite the fact that quality healthcare is vital to the well-being and functioning of a society, the shocking lack of communication innovation comes at a steep price, resulting in chronic delays, increased operational costs that are often passed down to the public, preventable medical errors, physician burnout, and in the worst cases, can even lead to death.”

The cost of communication inefficiencies in healthcare is considerable. According to NCBI, a 500-bed hospital loses more than $4 million each year as a result of communication inefficiencies and communication errors are the root cause of 70% of all medical error deaths.

The communication problems are certainly felt by healthcare employees, who waste valuable time battling with inefficient systems. The report reveals 55% of healthcare organizations believe the healthcare industry is behind the times in terms of communication technology compared to other consumer industries.

One of the main issues faced by healthcare professionals is not being able to get in touch with members of the care team when they need to. 39% of healthcare professionals said it was difficult or very difficult communicating with one or more groups of care team members.

Fast communication is critical for providing high quality care to patients and improvements are being made, albeit slowly. Secure messaging is now the primary method of communication overall for nurses (45%) and physicians (39%), although landlines are the main form of communication for allied health professionals (32%) and staff outside hospitals (37%), even though secure messaging platforms can be used by all groups in all locations.

Even though there is an increasing mobile workforce in healthcare, healthcare organizations are still heavily reliant on landlines. Landlines are still the top method of communication when secure messaging is not available. Landlines are also used 25% of the time at organizations that have implemented secure messaging.

Healthcare organizations that have taken steps to improve communication and have implemented secure messaging platforms are failing to get the full benefits of the technology. All too often, secure messaging technology is implemented in silos, with different groups using different methods and tools to communicate with each other. When secure messaging is not used, such as when the platform is only used by certain roles, communication is much more difficult.

The communications problems are also felt by patients. Nearly three quarters (74%) of surveyed patients who had spent at least some time in hospital in the past two years, either receiving treatment or visiting an immediate family member, said they were frustrated by inefficient processes.

The most common complaints were slow discharge/transfer times (31%), ED time with doctors (22%), long waiting room times (22%), the ability to communicate with a doctor (22%), and the length of time it takes to get lab test results back (15%). Many of these issues could be eased through improved communication between members of the care team. The survey also revealed hospital staff tend to underestimate the level of frustration that patients experience.

Communication problems play a large part in the bottlenecks that often occur in healthcare. Communication problems were cited as causing delayed discharges (50%), consult delays (40%), long ED wait times (38%), transport delays (33%) and slow inter-facility transfers (30%). There is a 50% greater chance of daily communication disconnects negatively impacting patients when secure messaging is not used.

Hospitals that communicate with patients by SMS/text or messaging apps are far more likely to rate their communication methods as effective or extremely effective. 75% of hospitals that use text/SMS and 73% that use messaging apps rate communication with patients as effective or very effective, compared to 62% that primarily use the telephone and 53% whose primary method of communicating with patients is patient portals. The survey also showed that only 20% of patients want to communicate via patient portals.

It has been established that secure messaging can improve communication and the quality of healthcare delivery, but healthcare communication is often not a strategic priority. 69% of surveyed healthcare professionals that are not using a secure messaging platform said this was due to budget constraints, 38% said money was spent on other IT priorities, and 34% cited concerns about patient data security, even though secure messaging platforms offer afar greater security than legacy communications systems.

TigerConnect has made several recommendations on how communication in healthcare needs to be improved.

  • Prioritize communication as a strategy
  • Focus on improving communication to ease major bottlenecks
  • Integrate communication platforms with EHRs to get the greatest value
  • Standardize communication across the entire organization
  • Include clinical leadership in solution design
  • Stop using patient portals to communicate with patients and start using patient messaging in the overall communication strategy.

The survey provides valuable insights into the state of communication in healthcare and clearly shows where improvements need to be made. The full TigerConnect 2019 State of Communication in Healthcare Report is available free of charge on this link (registration required).

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51% of Healthcare Providers Still Not Fully Complying with HIPAA Right of Access

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The Department of Health and Human Services’ Office for Civil Rights is cracking down on noncompliance with the HIPAA Right of Access and for good reason. A recent report from Ciitizen has revealed more than half of healthcare providers (51%) are not fully compliant with this aspect of HIPAA.

This is the second such report from Ciitizen, the first having been released on August 14, 2019. For the latest report, an additional 169 healthcare providers were assessed for Right of Access compliance, bringing the total assessed providers to 210.

Acting with authorization from patients, Ciitizen made requests for copies of patients records. Each healthcare provider was then given a rating based on their response, from 5 stars being fully compliant and responding within 5 days, down to 1 or 2 stars. A 1- or 2-star rating meant that were it not for multiple escalation calls to supervisors, the provider would not have been compliant.

There is some good news in the report. More providers are complying and there is less inconsistency from employee to employee. A growing number of healthcare providers are also now providing seamless access to patient records, with the percentage having increased from 30% to 40%.

The high figure or noncompliance is not because of the failure to provide patients with copies of their medical records on request, it is mostly because there needs to be “significant intervention” before requests are processed in a compliant manner.

For instance, the main reason for a 1-star rating is patients are not being provided with copies of their medical records in the digital format of their choosing. Inconsistency is also an issue. Many patients will be provided with copies of their records within 30 days, but a significant percentage will experience problems, such as having to make contact by phone on multiple occasions.

The findings from the first report were found to be broadly comparable to the second, although a far higher percentage of providers received a 1-star rating in the second report. In Cohort I (n=51), 27% received a 1-star rating and 24% received 2 stars. In Cohort II (n-169), 51% received a 1-star rating and 5% received a 2-star rating.

This can be explained by the fact that fewer escalation attempts were made by telephone after the initial request was submitted with Cohort II. That meant that the 30-day time limit for providing records was exceeded on occasion.

For Cohort II, out of the providers that were given a 1-star rating, 86% failed to provide the records in the requested format, 20% exceeded the 30-day time frame for providing records, and 1% attempted to charge excessive fees. In Cohort I, the figures were 86% format failures, 2% fee issues, and 2% failed to send the records to the designee. All requests were processed within 30 days.

It is important to point out that copies of records were requested in a specific digital format. Ciitizen said 76% of providers receiving a 1-star rating would have received a 4- or 5-star rating if they had been allowed to send records in any digital format (CD, fax, or encrypted email).

Ciitizen chose to request a specific digital format to assess compliance and better reflect real world scenarios. For instance, many patients do not have access to a fax machine and may not have a laptop/computer with a CD drive.

Ciitizen believes the use of standard open APIs would help to ensure that records could easily be provided in the format requested by the patient.

Ciitizen points out that providers are now accepting request forms by mail, email, and fax, which makes it far easier for patients to obtain a copy of their records. To date, excessive fees have not been an issue but, in some cases, this was only due to Ciitizen successfully resolving attempts by providers to charge fees that are not permitted under HIPAA by escalating the issue to supervisors.

The detailed Ciitizen report can be viewed and downloaded on this link.

Penalties for Noncompliance with HIPAA Right of Access

The penalties for noncompliance are can be severe. Willful neglect of HIPAA Rules now carries a minimum penalty of $58,490 per violation, if no corrective action has been taken, and a maximum penalty of $1,754,698 per violation, per year. OCR calculates penalties based on the number of days the organization has not been in compliance, so the maximum possible penalty is substantial.

OCR has stated on multiple occasions that HIPAA Right of Access failures are one of its main enforcement priorities. Already this year, OCR has issued one financial penalty for noncompliance with this important aspect of HIPAA and it will not be the last.

Bayfront Health St Petersburg was fined $85,000 for HIPAA Right of Access failures in September 2019 and in 2011, Cignet Health of Prince George’s County was ordered to pay a civil monetary penalty of $4,300,000 for denying patients access to their medical records.

It doesn’t take a data breach for an investigation into patient rights violations to be initiated by OCR. The Bayfront Health St Petersburg financial penalty was in response to a single complaint from a patient who had not been provided with her medical records in a timely manner.

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Google Confirms it has Legitimate Access to Millions of Ascension Patients’ Health Records

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Following a report in the Wall Street Journal, Google has confirmed it is collaborating with one of the largest healthcare systems in the United States, which gives it access to a huge volume of patient data.

Google has partnered Ascension, the world’s largest catholic health system and the second largest non-profit health system in the United States. Ascension operates more than 2,600 healthcare facilities in 21 states, including 150 hospitals and over 50 senior living facilities.

The collaboration has given Google access to patient health information such as names, dates of birth, medical test results, diagnoses, treatment information, service dates, and other personal and clinical information.

The project – code name Project Nightingale – had been kept under the radar prior to the WSJ Report, which claimed that at least 150 Google employees have allegedly been able to access patient data as part of the project and that access to patient data had been granted without patients or physicians being informed. Both Google and Ascension made announcements about the Project Nightingale collaboration after the WSJ story was published.

In a November 11 press release, Ascension said it “is working with Google to optimize the health and wellness of individuals and communities, and deliver a comprehensive portfolio of digital capabilities that enhance the experience of Ascension consumers, patients and clinical providers across the continuum of care.”

Google explained in its announcement that it had previously mentioned the collaboration in July 2019 in its Q2 earnings call, in which it stated, “Google Cloud’s AI and ML solutions are helping healthcare organizations like Ascension improve the healthcare experience and outcomes.”

Google explained in its November 11 blog post that collaboration with Ascension is focused on A) Shifting Ascension’s infrastructure to the Google Cloud platform; B) Helping Ascension implement G Suite productivity tools and; C) Extending tools to doctors and nurses to improve care. Google also stated that some of the tools it is working on are not yet active in clinical development and are still in the early testing stage, hence the code name, Project Nightingale.

Another goal of the collaboration is to use Google’s considerable computing capabilities to analyze patient data with a view to developing software that leverages its AI and machine learning technology to deliver more targeted care to patients.

Ascension said the it will be “Exploring artificial intelligence/machine learning applications that will have the potential to support improvements in clinical quality and effectiveness, patient safety, and advocacy on behalf of vulnerable populations, as well as increase consumer and provider satisfaction.”

As a business associate of Ascension, Google has confirmed that access to patient data is legitimate and in full compliance with Health insurance Portability and Accountability Act (HIPAA) Rules. Google has signed a BAA with Ascension and has implemented appropriate safeguards to keep patient information secure and is in full compliance with all requirements of HIPAA.

Ascension has also confirmed that the partnership is “underpinned by a robust data security and protection effort and adherence to Ascension’s strict requirements for data handling.”

While patients may be concerned that Google now has access to some of their most sensitive data, it is not standard practice for healthcare organizations to announce collaborations with third-party companies that provide services that require access to protected health information. However, a proactive announcement rather than a reactive press release may have helped allay fears and concerns.

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Sen. Warner Demands Answers from HHS Over Apparent Lack of Response to Major PACS Data Breach

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U.S. Senator, Mark. R. Warner (D-VA) has written to the Director of the HHS’ Office for Civil Rights, Roger Severino, expressing concern over the HHS response to the mass exposure of medical images by U.S. healthcare organizations.

Sen. Warner is the Vice Chairman of the Senate Intelligence Committee and co-founder of the Senate Cybersecurity Caucus. This is the latest in a series of communications in which he has voiced concerns about cybersecurity failures that have compromised the personal and private information of Americans. In February, Sen. Warner demanded answers from HHS agencies, NIST, and healthcare associations about healthcare cybersecurity following the continued increase in healthcare data breaches.

His recent letter to OCR was in response to a September 17, 2019 report about the exposure of millions of Americans’ medical images that were stored in unsecured picture archiving and communications systems (PACS).

The report detailed the findings of an investigation by ProPublica, German public broadcaster Bayerischer Rundfunk, and vulnerability and analysis firm, Greenbone Networks, which revealed almost 400 million medical images could be freely downloaded from the internet without authentication.  Sen. Warner pointed out that at the time of writing the letter, “for all U.S. territories there are 114.5 million images accessible, 22.1 million patient records, and 400,000 Social Security numbers, impacting an estimated 5 million patients in 22 states.”

Sen. Warner stated in the letter that the exposure of the medical images not only has potential to cause harm to individuals, it is also damaging to national security. The types of exposed information could potentially be used by cybercriminals in phishing campaigns and for other malicious attacks, such as those aimed at spreading malware. Flaws in the DICOM protocol could be exploited to incorporate malicious code into medical images. Nation state actors or cybercriminal groups could have downloaded the images, inserted malicious code, and then uploaded the images without being detected.

One of the U.S. firms implicated in the ProPublica report was TridentUSA Health Services and one of its affiliates, MobileX USA. In September 2019, following publication of the report, Sen. Warner wrote to TridentUSA Health Services demanding answers about its cybersecurity practices and how the data of millions of Americans, which the company was responsible for keeping private, came to be exposed online and required no password or other means of authentication to access.

In his letter to OCR, Sen. Warner explained that TridentUSA Health Services, a HIPAA-covered entity, responded to his letter and stated it had passed an HHS Security Rule audit in March 2019. That audit was passed even though at the time of the audit medical images under its control were exposed online and could be freely accessed over the internet.

“As your agency aggressively pushes to permit a wider range of parties (including those not covered by HIPAA) to have access to the sensitive health information of American patients without traditional privacy protections attaching to that information, HHS’s inattention to this particular incident becomes even more troubling,” wrote Warner.

The exposure of PACS data was reported to US-CERT by the German Federal Office for Information Security. US-CERT made contact with Greenbone Networks and confirmed the exposed data had been received and said that the matter would be reported to the HHS. Greenbone Networks had no contact from HHS and no further contact from US-CERT.

The researchers in Germany also demonstrated to Sen. Warner that even on October 15, 2019, several US-based PACS have open ports that support unencrypted communications protocols. Those unsecured PACS could be accessed without authentication and a wide range of medical images could be viewed and downloaded, including X-rays and mammograms that contain sensitive patient information such as names and Social Security numbers. Those images and personal information were still accessible freely online on the date of writing the letter (Nov 8, 2019).

“As of writing this letter, TridentUSA Health Services is not included on your breach portal website and I have seen no evidence that, once contacted by US-CERT, you acted on that information in a meaningful way,” wrote Sen. Warner.

Sen. Warner has demanded answers to 5 questions:

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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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