HIPAA Compliance News

Protecting Jessica Grubbs Legacy Act Reintroduced by Sens. Manchin and Capito

The Protecting Jessica Grubbs Legacy Act (S. 3374) has been reintroduced by Senators Joe Manchin (D-W.V.) and Shelley Moore Capito (R-W.V.). The Protecting Jessica Grubbs Legacy Act aims to modernize the 45 CRF Part 2 regulations to support the sharing of substance abuse disorder treatment records and improve care coordination.

42 CFR Part 2 regulations restrict the sharing of addiction records, which makes it very difficult for information to be shared about patients who are recovering from substance abuse disorder. Currently 45 CFR Part 2 regulations only permit substance abuse patients themselves to decide who has access to their full medical history. While the sharing of highly sensitive information about a patient’s history of substance abuse disorder and treatment is intended to protect the privacy of patients and ensure they are protected against discrimination, not making that information available to doctors can have catastrophic consequences, as happened with Jessica Grubbs.

Jessica Grubbs was recovering from substance abuse disorder when she underwent surgery. The discharging doctor prescribed oxycodone and Grubbs returned home with 50 oxycodone pills. She later died of an overdose. If the discharging doctor was made aware that Grubbs had a history of substance abuse disorder, a different medication could have been prescribed.

Medical providers are responsible for providing care to patients, but without access to their full medical histories, they are doing so blind. It is difficult for medical providers to make correct decisions about patients’ care if they only have access to incomplete medical records.

The Protecting Jessica Grubbs Legacy Act was introduced to ensure medical providers have access to all the necessary information, so they do not accidentally give opioid drugs to patients in recovery from substance abuse disorder. The Protecting Jessica Grubbs Legacy Act will help to ensure tragedies such as the death of Jessica Grubbs are prevented.

“No family or community should ever have to go through the senseless and preventable tragedy that Jessica Grubbs and her family had to endure,” said Sen. Manchin. “This bipartisan bill is essential to combating the opioid epidemic and ensuring that these painful deaths are prevented.”

Healthcare industry stakeholders have been pushing for changes to 42 CFR Part 2 regulations for several years and Congress has been petitioned to make changes to the regulations. In 2019, the National Association of Attorneys General wrote to House and Senate leaders calling for changes to the regulations, which were called cumbersome and out of date. 39 state attorneys general signed the letter. The HHS also proposed changes to 45 CFR Part 2 last year to align the regulations more closely with HIPAA.

The reintroduced Protecting Jessica Grubbs Legacy Act includes several revisions to the original act, S. 1012, which was introduced in April 2019. The language of the bill has been changed to require a patient to give their affirmative, written consent to opt-in before their information may be shared. An educational component has also been added that requires patients to be informed about exactly what they are consenting to before a final determination. An opt-out clause has also been added that allows patients to opt out and rescind their consent at any time. The revised Protecting Jessica Grubbs Legacy Act also calls for Part 2 regulations to be aligned more closely with HIPAA.

To ensure the privacy of patients is protected, enhancements have been made to current protections to prevent discrimination in relation to access to treatment, termination of employment, receipt of worker’s compensation, rental housing, and federal, state, and local government social services benefits.

The Secretary of the Department of Health and Human Services will be directed to consult with appropriate legal, clinical, privacy, and civil rights experts when updates are made to the Code of Federal Regulations to implement the changes proposed in the bill.

“This is an ideal compromise that alleviates the roadblocks to care coordination, while providing strong protections, and more importantly providing those suffering with substance use disorder, more comfortable in knowing they can share medical records in a protected manner and enforced with real penalties to prevent misuse of sensitive medical information,” said Sen. Manchin in a statement.

The revised bill has received considerable support from industry stakeholders and the bill has been co-sponsored by Sens. Sheldon Whitehouse (D-R.I), Kevin Cramer (R-N.D.), Dianne Feinstein (D-Calif.), Doug Jones (D-Ala.), Chris Murphy (D-Conn.), Thom Tillis (R-N.C.), Susan Collins (R-Maine), Kamala Harris (D-Calif.), Bill Cassidy (R-La.), Amy Klobuchar (D-Minn.), and Jeff Merkley (D-Ore.).

The post Protecting Jessica Grubbs Legacy Act Reintroduced by Sens. Manchin and Capito appeared first on HIPAA Journal.

Senators Demand Answers from Ascension About Project Nightingale as Google’s Response was Deemed Incomplete

Following the revelation that a considerable volume of patient data had been shared with Google by the Catholic health system Ascension, the second largest health system in the United States, concern was raised about the nature of the partnership.

Ascension operates 150 hospitals and more than 2,600 care facilities in 20 states and the District of Columbia and has more than 10 million patients. In November 2019, a whistleblower at Google passed information to the Wall Street Journal on the nature of the collaboration and claimed that patient data, including patient names, dates of birth, lab test results, diagnoses, health histories and other protected health information, had been shared with Google and was accessible by more than 150 Google employees.

In response to the story, Google announced that the partnership, named Project Nightingale, was a cloud migration and data sharing initiative. Ascension is migrating its data warehouse and analytics infrastructure to the Google Cloud and will be using Google’s G Suite productivity suite. Patient data was being used by Google’s AI and machine learning technologies with the purpose of improving clinical quality and patient safety.

Google and Ascension both unissued statements confirming that there was a business associate agreement in place and data was being shared in a manner compliant with Health Insurance Portability and Accountability Act (HIPAA) Rules and health data was not being used for purposes other than those stated in its BAA. Several investigations were launched to determine the nature of the agreement between both companies, with the HHS’ Office for Civil Rights opening an investigation into both companies to determine whether HIPAA Rules were being adhered to.

Three U.S. senators – Sen. Bill Cassidy, M.D., (R-LA), Elizabeth Warren (D-MA), and Richard Blumenthal (D-CT) – wrote to Google demanding answers about the collaboration. Google responded and explained that data was shared in accordance with HIPAA Rules, that only a limited number of employees have access to that data, that access controls are in place to prevent unauthorized access, and any individual required to access health data is set permissions based on their role and job function.

Google also explained that Ascension’s data is logically isolated from other customers and confirmed that the data was only being used for an EHR search pilot program that would provide physicians and nurses with a unified view of patient data from multiple EHR systems. The EHR search tool will allow medical staff to search data in EHRs faster and effectively query medical records using words and abbreviations commonly used in healthcare. Google confirmed that medical records were not being used for secondary purposes, such as identifying services for specific individuals or to send them targeted advertisements.

The senators believe the answers provided by Google are incomplete. On Monday, they wrote to Ascension demanding answers about Project Nightingale and the patient data shared with Google. “Google’s response did not answer a number of our questions pertaining to Ascension’s involvement, we are requesting additional details from Ascension to help us better understand how Project Nightingale protects the sensitive health information of American patients,” explained the senators.

The senators want to know how many records have been shared with Google, the exact nature of the information that was shared, if there have been any breaches of the shared data, and whether patients were notified that their PHI would be shared with Google and if they were given the opportunity to opt out.

“It’s critical lawmakers receive comprehensive information about Project Nightingale, which serves as a case study of Google’s more extensive foray into electronic health records,” explained the senators in the letter. “While improving the sharing, accessibility, and searchability of health data for providers could almost certainly lead to improvements in care, the role of Google in developing such a tool warrants scrutiny.”

The post Senators Demand Answers from Ascension About Project Nightingale as Google’s Response was Deemed Incomplete appeared first on HIPAA Journal.

HHS’ Office for Civil Rights Announces First HIPAA Penalty of 2020

The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced its first HIPAA penalty of 2020. The practice of Steven A. Porter, M.D., has agreed to pay a financial penalty of $100,000 to resolve potential violations of the HIPAA Security Rule and will adopt a corrective action plan to address all areas of noncompliance discovered during the compliance investigation.

Dr. Porter’s practice in Ogden, UT provides gastroenterological services to more than 3,000 patients. OCR launched an investigation following a report of a data breach in November 13, 2013. The breach concerned a business associate of Dr. Porter’s electronic medical record (EHR) company which was allegedly impermissibly using patients’ electronic medical records by blocking the practice’s access to ePHI until Dr. Porter paid the company $50,000.

The breach investigation uncovered serious violations of the HIPAA Security Rule at the practice. At the time of the audit, Dr. Porter had never conducted a risk analysis to identify risks to the confidentiality, integrity, and availability of ePHI, in violation of 45 C.F.R. § 164.308(a)(1)(i), the practice had not reduced risks to a reasonable and appropriate level, and had not implemented policies and procedures to prevent, detect, contain, and correct security violations.

Since at least 2013, the practice had allowed Dr. Porter’s EHR company to create, receive, maintain, or transmit ePHI on behalf of the practice, without first receiving satisfactory assurances that the company would implement safeguards to ensure the confidentiality, integrity, and availability of ePHI, in violation of 45 C.F.R. § 164.308(b).

Throughout the course of the investigation, OCR provided significant technical assistance, yet a risk analysis was not conducted after the breach and appropriate security measures were not implemented to reduce risks to a reasonable and appropriate level.

The financial penalty shows that healthcare providers of all sizes must take their responsibilities under HIPAA seriously. “The failure to implement basic HIPAA requirements, such as an accurate and thorough risk analysis and risk management plan, continues to be an unacceptable and disturbing trend within the health care industry,” said OCR Director, Roger Severino.

The post HHS’ Office for Civil Rights Announces First HIPAA Penalty of 2020 appeared first on HIPAA Journal.

American Medical Association Publishes Playbook Dispelling Common HIPAA Right of Access Myths

The American Medical Association (AMA) has published a new HIPAA playbook to help physicians and their practices understand the HIPAA Right of Access and ensure compliance with this important requirement of HIPAA.

Misunderstandings about the HIPAA Right of Access can result in financial penalties for noncompliance. The HHS’ Office for Civil Rights launched a new HIPAA Right of Access enforcement initiative in 2019 and has already taken action against two healthcare organizations that were not providing patients with copies of their medical records in a timely manner. Both cases started with a single complaint from a patient who was not provided with a copy of the requested records and ended with a $85,000 financial penalty.

Patients need to be able to access their healthcare data to be able to make informed decisions about their own health. HIPAA gives patients the right to obtain a copy of their health records, but healthcare providers can face challenges complying with all of the legal requirements of HIPAA. These challenges, together with misunderstandings about the HIPAA Right of Access, have prevented some providers from complying with patient requests for copies of their health information.

The Patient Records Electronic Access Playbook was released to educate physicians and their practices about the need to provide patients with access to their medical records and the legal requirements related to medical record access and the sharing of records with patients.

The 104-page document is divided into four parts and covers the legal requirements of HIPAA and patient access laws and the challenges physician practices face complying with the HIPAA Right of Access. The playbook includes guidance to help physicians overcome challenges and best practices for operationalizing records access fulfillment.

The document also dispels some of the common myths about providing patients and third parties with health records, the health information that can and cannot be shared, the amount that healthcare providers can change for providing copies of medical records, and how medical records must be provided.

The playbook explains that even when patient portals are in use compliance with the HIPAA Right of Access is far from guaranteed. Patient portals do not typically allow patients to access all of their health information and copies of medical records will still need to be provided to patients. AMA recommends giving patients the opportunity to access their health data over several different media. The playbook also covers providing health records to third parties at the request of a patient and requests originating from third parties, which are two aspects of the HIPAA Right of Access that have caused confusion for many physician practices.

AMA says in the playbook that healthcare providers need to learn about the capabilities of their EHRs, and discover how patient records can be sent to other healthcare providers, how information can be fed into patient portals, and how to export patient records to USB drives or CDs.

Healthcare providers should also actively encourage patients to take a greater interest in their healthcare and obtain a copy of their health records and check those records for errors. “Most importantly, encourage each patient to use apps and access to health information to become an active champion of his or her health,” says AMA. “Patients can better manage their health by understanding and managing all of their health information.”

The post American Medical Association Publishes Playbook Dispelling Common HIPAA Right of Access Myths appeared first on HIPAA Journal.

Webinar 03/18/20: Discover the Untold Benefits of HIPAA Compliance

If you are a HIPAA-covered entity, current business associate, or you are looking to start providing services to healthcare organizations, you will need to ensure that your business is fully compliant with Health Insurance Portability and Accountability Act Rules.

In the event of a compliance audit or data breach investigation you will need to demonstrate that you have implemented an effective compliance program and are compliant with the HIPAA Privacy, Security, Omnibus, and Breach Notification Rules. However, there are many more benefits to HIPAA compliance than simply being able to pass a compliance audit.

On March 18, 2020, HIPAA Journal sponsor, Compliancy Group, will be hosting a free webinar to explain the full benefits of HIPAA compliance and the lasting positive impact HIPAA compliance can have on your organization, from protecting your reputation to differentiating your business from the competition.

During the webinar you will be provided with tips on how your organization can start leveraging the true benefits of HIPAA compliance and by the end of the session you will have learned how you can start using compliance to grow your business!

Webinar Details:

Date: Wednesday, March 18, 2020

Time: 2:00 pm ET / 11:oo am PT

Register for the Webinar

About Compliancy Group

Compliancy Group is the industry leader in HIPAA compliance. The company offers an affordable service to help your business meet all its obligations under the HIPAA Rules.

The company was founded in 2005 by former compliance auditors who found there were few options available to small-to medium-sized businesses to effectively address compliance without having to use incomplete solutions or hire expensive lawyers.

Compliance Group developed a software solution, The Guard, that steers businesses through the compliance process. Compliancy Group is the only compliance company that provides guided support to simplify the compliance process.

In the event of a compliance audit, help will be provided to ensure it runs as smoothly as possible. No Compliancy Group client has ever failed a compliance audit.

The post Webinar 03/18/20: Discover the Untold Benefits of HIPAA Compliance appeared first on HIPAA Journal.

January 2020 Healthcare Data Breach Report

In January, healthcare data breaches of 500 or more records were reported to the Department of Health and Human Services’ Office for Civil Rights at a rate of more than one a day.

As our 2019 Healthcare Data Breach Report showed, 2019 was a particularly bad year for healthcare data breaches with 510 data breaches reported by HIPAA-covered entities and their business associates. That equates to a rate of 42.5 data breaches per month. January’s figures are an improvement, with a reporting rate of 1.03 breaches per day. There was also a 15.78% decrease in reported breaches compared to December 2019.

healthcare data breaches February 2019 to January 2020

Healthcare data breaches in January

While the number of breaches was down, the number of breached records increased by 17.71% month-over-month. 462,856 healthcare records were exposed, stolen, or impermissibly disclosed across 32 reported data breaches. As the graph below shows, the severity of data breaches has increased in recent years.

Largest Healthcare Data Breaches in January 2020

Name of Covered Entity State Covered Entity Type Individuals Affected Type of Breach Location of Breached Information
PIH Health CA Healthcare Provider 199,548 Hacking/IT Incident Email
Douglas County Hospital d/b/a Alomere Health MN Healthcare Provider 49,351 Hacking/IT Incident Email
InterMed, PA ME Healthcare Provider 33,000 Hacking/IT Incident Email
Fondren Orthopedic Group L.L.P. TX Healthcare Provider 30,049 Hacking/IT Incident Network Server
Native American Rehabilitation Association of the Northwest, Inc. OR Healthcare Provider 25,187 Hacking/IT Incident Email
Central Kansas Orthopedic Group, LLC KS Healthcare Provider 17,214 Hacking/IT Incident Network Server
Hospital Sisters Health System IL Healthcare Provider 16,167 Hacking/IT Incident Email
Spectrum Healthcare Partners ME Healthcare Provider 11,308 Hacking/IT Incident Email
Original Medicare MD Health Plan 9,965 Unauthorized Access/Disclosure Other
Lawrenceville Internal Medicine Assoc, LLC NJ Healthcare Provider 8,031 Unauthorized Access/Disclosure Email

Causes of January 2020 Healthcare Data Breaches

2019 saw a major increase in healthcare data breaches caused by hacking/IT incidents. In 2019, more than 59% of data breaches reported to the HHS’ Office for Civil Rights were the result of hacking, malware, ransomware, phishing attacks, and other IT security breaches.

Causes of January 2020 Healthcare Data Breaches

Hacking/IT incidents continued to dominate the breach reports in January and accounted for 59.38% of all breaches reported (19 incidents). 28.13% of reported breaches were classified as unauthorized access/disclosure data breaches (9 incidents), there were two reported theft incidents, both involving physical records, and 2 cases of improper disposal of physical records. Ransomware attacks continue to plague the healthcare industry, but phishing attacks are by far the biggest cause of healthcare data breaches. As the above table shows, these attacks can see the PHI of tens of thousands or even hundreds of thousands of patients exposed or stolen.


Hacking/IT incidents tend to be the most damaging type of breach and involve more healthcare records than other breach types. In January, 416,275 records were breached in hacking/IT incidents. The average breach size was 21,909 records and the median breach size was 6,524 records. 26,450 records were breaches as a result of unauthorized access/disclosure incidents. The average breach size was 26,450 records and the median breach size was 2,939 records.

11,284 records were stolen in theft incidents with an average breach size of 5,642 records. The two improper disposal incidents saw 2,812 records discarded without first rendering documents unreadable and undecipherable. The average breach size was  1,406 records. 
Location of breached protected health information

Regular security awareness training for employees has been shown to reduce susceptibility to phishing attacks, but threat actors are conducting increasingly sophisticated attacks. It is often hard to distinguish a phishing email from a genuine message, especially in the case of business email compromise scams.

What is needed to block these attacks is a defense in depth approach and no one technical solution will be effective at blocking all phishing attacks. Defenses should include an advanced spam filter to block phishing messages at source, a web filter to block access to websites hosting phishing kits, DMARC to identify email impersonation attacks, and multi-factor authentication to prevent compromised credentials from being used to access email accounts.

Healthcare Data Breaches by Covered Entity

Healthcare providers were the worst affected by data breaches in January with 25 reported breaches of 500 or more healthcare records. Five breaches were reported by health plans, and two breaches were reported by business associates of HIPAA-covered entities. There were a further three data breaches reported by covered entities that had some business associate involvement.

January 2020 Healthcare Data Breaches by Covered Entity

January 2020 Healthcare Data Breaches records exposed covered entity

Healthcare Data Breaches by State

HIPAA covered entities and business associates in 23 states reported data breaches in January. California and Texas were the worst affected with three reported breaches in each state. There were two breaches reported in each of Florida, Illinois, Maine, Minnesota, and New York, and one breach was reported in each of Alabama, Arizona, Colorado, Connecticut, Georgia, Iowa, Indiana, Kansas, Maryland, Michigan, North Carolina, New Jersey, Oregon, Pennsylvania, South Carolina, and Virginia.

HIPAA Enforcement in January 2020

There were no financial penalties imposed on HIPAA covered entities or business associates by the HHS’ Office for Civil Rights or state attorneys general in January.

There was a notable increase in the number of lawsuits filed against healthcare organizations that have experienced data breaches related to phishing and ransomware attacks.

January saw a lawsuit filed against Health Quest over a July 2018 phishing attack, Tidelands Health is being sued over a December 2019 ransomware attack, and a second lawsuit was filed against DCH Health System over a malware attack involving the Emotet and TrickBot Trojans that occurred in October 2019. These lawsuits follow legal action against Kalispell Regional Healthcare and Solara Medical Supplies in December.

The trend has continued in February with several law firms racing to be the first to file lawsuits against PIH Health in California over a 2019 phishing attack that exposed the data of more than 200,000 individuals.

These lawsuits may cite HIPAA violations, but since there is no private cause of action under HIPAA, legal action is taken over violations of state laws.

The post January 2020 Healthcare Data Breach Report appeared first on HIPAA Journal.

Criminal HIPAA Violation Case Sees Healthcare Worker Charged on 415 Counts

A former employee of ACM Global Laboratories, part of Rochester Regional Health, has been accused of accessing the medical records of a patient, without authorization, on hundreds of occasions in an attempt to find information that could be used in a child custody battle.

A criminal investigation was launched into the alleged HIPAA violations by Jessica Meier, 41, of Hamlin, NY, when it was suspected that she had been abusing her access rights to patient information for malicious purposes.

Kristina Ciaccia was previously in a relationship with Meier’s half brother and has been in a lengthy child custody battle. In court, Ciaccia heard about a historic visit by her own brother to the emergency room at Rochester Regional Health, when she herself was unaware of the visit. Suspecting snooping on her family’s medical records, Ciaccia reported the matter to Rochester Regional Health.

According to court documents, the Rochester Regional Health audit revealed Meier had accessed the private medical records of Ciaccia on more than 200 occasions between March 2017 and August 2019, without any legitimate work purpose for doing so. It was also confirmed that Meier had accessed the medical records of members of Ciaccia’s family.

Ciaccia reported the criminal HIPAA violations to the police and an investigation was launched. Meier was arraigned in Gates Town Court on Tuesday, February 11, 2019 on 215 felony counts of computer trespass and 215 counts of misdemeanor unauthorized use of a computer. Meier pleaded not guilty to all counts and the case is expected to go before a grand jury.

“If you go in somebody’s medical records, you deserve to be charged. You deserve to be held accountable,” Ciaccia told News 10 NBC. Ciaccia also believes Rochester Regional Health should be held accountable, not for the breach itself, but for the failure to identify an ongoing privacy violation that spanned more than two years.

The unauthorized medical record access was only discovered after Ciaccia reported the potential privacy violation to Rochester Regional Health. “I feel like Rochester Regional pay her all year to go in my medical records, said Ciaccia.” Upon discovery of unauthorized access, Rochester Regional Health took disciplinary action against Meier.

HIPAA requires healthcare organizations to implement safeguards to ensure the confidentiality, integrity, and availability of patient information. Even if access controls and other measures are implemented, it is not possible to prevent all cases of improper accessing of medical records by employees. However, when instances occur, they should be identified quickly.

HIPAA requires audit logs to be maintained to track access to protected health information. Those logs allow audits to take place, as was the case when the matter was brought to the attention of Rochester Regional Health by Ciaccia.

HIPAA also requires audit logs to be regularly checked to identify unauthorized accessing of PHI. Had the audit logs been monitored more closely, the privacy violation could have been identified and sanctions could have been applied against Meier sooner.

The post Criminal HIPAA Violation Case Sees Healthcare Worker Charged on 415 Counts appeared first on HIPAA Journal.

OIG Audit Reveals Widespread Improper Use of Medicare Part D Eligibility Verification Transactions

An audit conducted by the Department of Health and Human Services’ Office of Inspector General (OIG) has revealed many pharmacies and other healthcare providers are improperly using Medicare beneficiaries’ data.

OIG conducted the audit at the request of the HHS’ Centers for Medicare and Medicaid Services (CMS) to determine whether there was inappropriate access and use of Medicare recipients’ data by mail-order and retail pharmacies and other healthcare providers, such as doctors’ offices, clinics, long-term care facilities, and hospitals.

CMS was concerned that a mail order pharmacy and other healthcare providers were misusing Medicare Part D Eligibility Verification Transactions (E1 transactions), which should be only be used to verify Medicare recipients’ eligibility for certain coverage benefits.

OIG conducted the audit to determine whether E1 transactions were only being used for their intended purpose. Since E1 transactions contain Medicare beneficiaries’ protected health information (PHI), they could potentially be used for fraud or other malicious or inappropriate purposes.

An E1 transaction consists of two parts – a request and a response. The healthcare provider submits an E1 request that contains an NCPDP provider ID number or NPI, along with basic patient demographic data.  The request is forwarded onto the transaction facilitator which matches the E1 request data with the data contained in the CMS Eligibility file. A response is then issued, which contains a beneficiary’s Part D coverage information.

The audit was conducted on one mail-order pharmacy and 29 providers selected by CMS. Out of 30 entities audited, 25 used E1 transactions for a purpose other than billing for prescriptions or to determine drug coverage order when beneficiaries are covered by more than one insurance plan. 98% of those 25 providers’ E1 transactions were not associated with prescriptions.

OIG found providers were obtaining coverage information for beneficiaries without prescriptions, E1 transactions were being used to evaluate marketing leads, some providers had allowed marketing companies to submit E1 transactions for marketing purposes, providers were obtaining information about private insurance coverage for items not covered under Part D, long term care facilities had obtained Part D coverage using batch transactions, and E1 transactions had been submitted by 2 non-pharmacy providers.

E1 transactions are covered transactions under HIPAA, PHI must be protected against unauthorized access while it is being electronically stored or transmitted between covered entities, and the minimum necessary standard applies. The findings suggest HIPAA is being violated and that this could well be a nationwide problem. Based on the findings of the audit and apparent widespread improper access and use of PHI, OIG will be expanding the audits nationwide.

OIG believes these issues have arisen because CMS has not yet fully implemented controls to monitor providers who are submitting high numbers of E1 transactions relative to prescriptions provided; CMS has yet to issue clear guidance that E1 transactions must not be used for marketing purposes; and CMS has not limited non-pharmacy access.

Following the audit, CMS took further steps to monitor for abuse of the eligibility verification system and will be taking appropriate enforcement actions when cases of misuse are discovered. OIG has recommended CMS issue clear guidance on E1 transactions and ensure that only pharmacies and other authorized entities submit E1 transactions.

The post OIG Audit Reveals Widespread Improper Use of Medicare Part D Eligibility Verification Transactions appeared first on HIPAA Journal.

2019 Healthcare Data Breach Report

Figures from the Department of Health and Human Services’ Office for Civil Rights breach portal show a major increase in healthcare data breaches in 2019. Last year, 510 healthcare data breaches of 500 or more records were reported, which represents a 196% increase from 2018.

As the graph below shows, aside from 2015, healthcare data breaches have increased every year since the HHS’ Office for Civil Rights first started publishing breach summaries in October 2009.

37.47% more records were breached in 2019 than 2018, increasing from 13,947,909 records in 2018 to 41,335,889 records in 2019.

Last year saw more data breaches reported than any other year in history and 2019 was the second worst year in terms of the number of breached records. More healthcare records were breached in 2019 than in the six years from 2009 to 2014. In 2019, the healthcare records of 12.55% of the population of the United States were exposed, impermissibly disclosed, or stolen.

Largest Healthcare Data Breaches of 2019

The table below shows the largest healthcare data breaches of 2019, based on the entity that reported the breach.

Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach Location of Breached Information
1 Optum360, LLC Business Associate 11500000 Hacking/IT Incident Network Server
2 Laboratory Corporation of America Holdings dba LabCorp Healthcare Provider 10251784 Hacking/IT Incident Network Server
3 Dominion Dental Services, Inc., Dominion National Insurance Company, and Dominion Dental Services USA, Inc. Health Plan 2964778 Hacking/IT Incident Network Server
4 Clinical Pathology Laboratories, Inc. Healthcare Provider 1733836 Unauthorized Access/Disclosure Network Server
5 Inmediata Health Group, Corp. Healthcare Clearing House 1565338 Unauthorized Access/Disclosure Network Server
6 UW Medicine Healthcare Provider 973024 Hacking/IT Incident Network Server
7 Women’s Care Florida, LLC Healthcare Provider 528188 Hacking/IT Incident Network Server
8 CareCentrix, Inc. Healthcare Provider 467621 Hacking/IT Incident Network Server
9 Intramural Practice Plan – Medical Sciences Campus – University of Puerto Rico Healthcare Provider 439753 Hacking/IT Incident Network Server
10 BioReference Laboratories Inc. Healthcare Provider 425749 Hacking/IT Incident Other
11 Bayamon Medical Center Corp. Healthcare Provider 422496 Hacking/IT Incident Network Server
12 Memphis Pathology Laboratory d/b/a American Esoteric Laboratories Healthcare Provider 409789 Unauthorized Access/Disclosure Network Server
13 Sunrise Medical Laboratories, Inc. Healthcare Provider 401901 Hacking/IT Incident Network Server
14 Columbia Surgical Specialist of Spokane Healthcare Provider 400000 Hacking/IT Incident Network Server
15 Sarrell Dental Healthcare Provider 391472 Hacking/IT Incident Network Server
16 UConn Health Healthcare Provider 326629 Hacking/IT Incident Email
17 Premier Family Medical Healthcare Provider 320000 Hacking/IT Incident Network Server
18 Metro Santurce, Inc. d/b/a Hospital Pavia Santurce and Metro Hato Rey, Inc. d/b/a Hospital Pavia Hato Rey Healthcare Provider 305737 Hacking/IT Incident Network Server
19 Navicent Health, Inc. Healthcare Provider 278016 Hacking/IT Incident Email
20 ZOLL Services LLC Healthcare Provider 277319 Hacking/IT Incident Network Server

 

The above table does not tell the full story. When a business associate experiences a data breach, it is not always reported by the business associate. Sometimes a breach is experienced by a business associate and the covered entities that they work with report the breaches separately, as was the case with American Medical Collection Agency (AMCA), a collection agency used by several HIPAA covered entities.

In 2019, hackers gained access to AMCA systems and stole sensitive client data. The breach was the second largest healthcare data breach ever reported, with only the Anthem Inc. data breach of 2015 having impacted more individuals.

HIPAA Journal tracked the breach reports submitted to OCR by each affected covered entity. At least 24 organizations are known to have had data exposed/stolen as a result of the hack.

Organizations Affected by the 2019 AMCA Data Breach

Healthcare Organization Confirmed Victim Count
Quest Diagnostics/Optum360 11,500,000
LabCorp 10,251,784
Clinical Pathology Associates 1,733,836
Carecentrix 467,621
BioReference Laboratories/Opko Health 425,749
American Esoteric Laboratories 409,789
Sunrise Medical Laboratories 401,901
Inform Diagnostics 173,617
CBLPath Inc. 141,956
Laboratory Medicine Consultants 140,590
Wisconsin Diagnostic Laboratories 114,985
CompuNet Clinical Laboratories 111,555
Austin Pathology Associates 43,676
Mount Sinai Hospital 33,730
Integrated Regional Laboratories 29,644
Penobscot Community Health Center 13,299
Pathology Solutions 13,270
West Hills Hospital and Medical Center / United WestLabs 10,650
Seacoast Pathology, Inc 8,992
Arizona Dermatopathology 5,903
Laboratory of Dermatology ADX, LLC 4,082
Western Pathology Consultants 4,079
Natera 3,035
South Texas Dermatopathology LLC 15,982
Total Records Breached 26,059,725

Causes of 2019 Healthcare Data Breaches

The HHS’ Office for Civil Rights assigns breaches to one of five different categories:

  • Hacking/IT incidents
  • Unauthorized access/disclosures
  • Theft
  • Loss
  • Improper disposal

59.41% of healthcare data breaches in 2019 were classified as hacking/IT incidents and involved 87.60% of all breached records. 28.82% of data breaches were classed as unauthorized access/disclosure incidents and involved 11.27% of all records breached in 2019.

10.59% of breaches were classed as loss and theft incidents involving electronic devices containing unencrypted electronic protected health information or physical records. Those incidents accounted for 1.07% of breached records in 2019.

1.18% of breaches and 0.06% of breached records were due to improper disposal of physical records and devices containing electronic protected health information.

Breach Cause Incidents Breached Records Mean Breach Size Median Breach Size
Hacking/IT Incident 303 36,210,097 119,505 6,000
Unauthorized Access/Disclosure 147 4,657,932 31,687 1,950
Theft 39 367,508 9,423 2,477
Loss 15 74,271 4,951 3,135
Improper Disposal 6 26,081 4,347 4,177

We have not tracked the cause of each breach reported in 2019, but the table below provides an indication of the biggest problem area for healthcare organizations – Securing email systems and blocking phishing attacks. The email incidents include misdirected emails, but the majority of email incidents were phishing and spear phishing attacks.

Healthcare Data Breaches by Covered Entity

77.65% of 2019 data breaches were reported by healthcare providers (369 incidents), 11.57% of breaches were reported by health plans (59 incidents), and 0.39% of data breaches were reported by healthcare clearinghouses (2 incidents).

23.33% of the year’s breaches involved business associates to some extent. 10.39% of data breaches were reported by business associates (53 incidents) and 66 data breaches were reported by a covered entity which stated there was some business associate involvement.

States Worst Affected by Healthcare Data Breaches

Data breaches were reported by HIPAA-covered entities or business associates in 48 states, Washington DC, and Puerto Rico. The worst affected state was Texas with 60 data breaches reported. California was the second most badly hit with 42 reported data breaches.

The only states where no data breaches of 500 or more records were reported were North Dakota and Hawaii.

State Breaches State Breaches State Breaches State Breaches State Breaches
Texas 60 Maryland 14 Arkansas 9 Alabama 4 Mississippi 2
California 42 Washington 14 South Carolina 9 Alaska 4 Montana 2
Illinois 26 Georgia 13 New Jersey 8 Iowa 4 South Dakota 2
New York 25 North Carolina 13 Massachusetts 7 Kentucky 4 Washington DC 2
Ohio 25 Tennessee 11 Puerto Rico 7 Nebraska 4 West Virginia 2
Minnesota 23 Arizona 10 Virginia 7 Oklahoma 4 Delaware 1
Florida 22 Colorado 10 Louisiana 6 Utah 4 Kansas 1
Pennsylvania 19 Connecticut 10 New Mexico 6 Wyoming 3 New Hampshire 1
Missouri 17 Indiana 10 Wisconsin 6 Idaho 2 Rhode Island 1
Michigan 16 Oregon 10 Nevada 5 Maine 2 Vermont 1

HIPAA Enforcement in 2019

The HHS’ Office for Civil Rights continued to enforce compliance with HIPAA at a similar level to the previous three years.

In 2019, there were 10 HIPAA enforcement actions that resulted in financial penalties. 2 civil monetary penalties were imposed and 8 covered entities/business associates agreed settlements with OCR to resolve HIPAA violations.

In total, $12,274,000 was paid to OCR in fines and settlements. The largest financial penalties of the year resulted from investigations of potential HIPAA violations by University of Rochester Medical Center and Touchstone Medical Imaging. Both cases were settled for £3,000,000.

OCR uncovered multiple violations of HIPAA Rules while investigating separate loss/theft incidents reported by University of Rochester Medical Center. OCR discovered risk analysis and risk management failures, a lack of encryption on portable electronic devices, and insufficient device and media controls.

Touchstone Medical Imaging experienced a data breach that resulted in the impermissible disclosure of 307,839 individuals’ PHI due to the exposure of an FTP server over the internet. OCR investigated and determined there had been risk analysis failures, business associate agreements failures, insufficient access rights, a failure to respond to a security incident, and violations of the HIPAA Breach Notification Rule.

Sentara Hospitals agreed to a $2.175 million settlement stemming from a 577-record data breach that was reported to OCR as only affecting 8 individuals. OCR told Sentara Hospitals that the breach notification needed to be updated to include the other individuals affected by the mailing error, but Sentara Hospitals refused. OCR determined a financial penalty was appropriate for the breach notification reporting failure and the lack of a business associate agreement with one of its vendors.

A civil monetary penalty of $2.154 million was imposed on the Miami, FL-based nonprofit academic medical system, Jackson Health System (JHS). Following a data breach, OCR investigated and found a compliance program that had been in disarray for several years. The CMP resolved multiple violations of HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.

A civil monetary penalty of $1,600,000 was imposed on Texas Department of Aging and Disability Services for multiple violations of HIPAA Rules discovered during the investigation of breach involving an exposed internal application. OCR discovered there had been risk analysis failures, access control failures, and information system activity monitoring failures, which contributed to the impermissible disclosure of 6,617 patients’ ePHI.

Medical Informatics Engineering, an Indiana-based provider of electronic medical record software and services, experienced a major data breach in 2015 at its NoMoreClipboard subsidiary. Hackers used a compromised username and password to gain access to a server that contained the protected health information (PHI) of 3.5 million individuals. OCR determined there had been a risk analysis failure and the case was settled for $100,000. MIE also settled a multi-state action with state attorneys general over the same breach and settled that case for $900,000.

The Carroll County, GA ambulance company, West Georgia Ambulance, was investigated over the reported loss of an unencrypted laptop computer that contained the PHI of 500 patients. OCR found there had been a risk analysis failure, there was no security awareness training program for staff, and HIPAA Security Rule policies and procedures had not been implemented. The case was settled for $65,000.

There was one financial penalty for a social media HIPAA violation. Elite Dental Associates respondents to patient reviews on Yelp, and in doing so impermissibly disclosed PHI. OCR determined a financial penalty was appropriate and the case was settled for $10,000.

OCR also launched a new HIPAA enforcement initiative in 2019, under which two settlements were reached with covered entities over HIPAA Right of Access failures. Korunda Medical and Bayfront Health St. Petersburg had both failed to respond to patient requests for copies of their health information within a reasonable time frame. Both covered entities settled their HIPAA violation cases with OCR for $85,000.

OCR HIPAA Settlements and Civil Monetary Penalties in 2019

HIPAA Enforcement by State Attorneys General in 2019

State attorneys general can also take action over violations of HIPAA Rules. There were three cases against covered entities and business associates in 2019. As previously mentioned, Medical Informatics Engineering settled a multi-state lawsuit and paid a financial penalty of $900,000.

A second multi-state action was settled by Premera Blue Cross. The lawsuit pertained to a 2015 hacking incident that resulted in the theft of 10.4 million records. The investigation uncovered multiple violations of violations of HIPAA Rules and resulted in a $10 million financial penalty.

The California attorney general also took legal action over a data breach that affected 1,991 California residents. The health insurer Aetna had sent two mailings to its members in which highly sensitive information relating to HIV and Afib diagnoses was visible through the windows of the envelopes. The case was settled for $935,000.

The post 2019 Healthcare Data Breach Report appeared first on HIPAA Journal.