Poor Risk Analysis Cost 4 firms $1.7 Million in HIPAA Fines – GovInfoSecurity
Setbacks Cost Healthcare Firms $1.7M in HIPAA Fines – GovInfoSecurity
House Republicans Make New Attempt to Introduce Federal Data Privacy Legislation – The HIPAA Journal
House Republicans Make New Attempt to Introduce Federal Data Privacy Legislation
House Republicans have made a fresh attempt to introduce federal data privacy legislation that, if passed, will replace the current patchwork of state privacy laws. The new privacy bill – the Securing and Establishing Consumer Uniform Rights and Enforcement over Data (SECURE Data) Act, and a companion bill covering financial firms – the GUARD Financial Data Act – were introduced by Republican members of the House Committee on Energy and Commerce and the House Committee on Financial Services. Unlike previous attempts to enact comprehensive federal data privacy legislation, the SECURE Data Act and GUARD Financial Data Act are not bipartisan. No input was sought from Democratic committee members.
Efforts to develop the bills were led by Congressman John Joyce, M.D., Chairman of the House Committee on Energy and Commerce, who led the Energy and Commerce Data Privacy Working Group, and Congressman John Joyce, M.D. (PA-13), Chairman of the Energy and Commerce Subcommittee on Oversight and Investigations and leader of the Energy and Commerce Data Privacy Working Group.
The bills were developed following more than a year of stakeholder consultation, and aim to create new federal data privacy standards, and are based on common data subject rights and provisions from states that have implemented their own comprehensive data privacy laws.
Key consumer rights in the SECURE Data Act include:
- The right to know data is being collected and used
- The right to access a copy of the personal data collected by an entity, including in a portable format
- The right to request that their personal data be deleted
- The right to opt out of targeted advertising, the sale of their personal data, and certain automated decisions
- To only process sensitive data with a consumer’s consent
- To only process a child or teen’s personal data with parental consent
The obligations for covered businesses under the SECURE Data Act include:
- Limiting the collection of personal data to what is “adequate, relevant, and reasonably necessary for the purposes disclosed to consumers
- Required disclosure of the personal data shared with others, and any personal data processed in or sold to China, Russia, or other foreign adversaries.
- Implementation of data security practices to protect the personal data they process.
There are specific requirements for data brokers, which include:
- Data minimization, disclosure, and data security requirements.
- Registration with the FTC, including disclosure of the privacy and data security practices and personal data sold.
- The FTC will establish a searchable public-facing registry of data brokers, where consumers can learn how to exercise their privacy rights.
“This bill establishes clear, enforceable protections so that Americans remain in charge of their own data and companies are held accountable for its safe keeping,” Energy and Commerce Chair Brett Guthrie, R-Ky., and Rep. John Joyce, R-Penn., said in a joint statement. “We look forward to working with our colleagues to build support for this bill and advance data privacy protections fit for our 21st century economy.”
The SECURE Data Act would apply to nonfinancial firms that control consumer data, exempting financial data and financial institutions covered by the Gramm-Leach-Bliley Act. The companion bill, the GUARD Financial Data Act, would update the Gramm-Leach-Bliley Act and would exempt nonfinancial firms. While there is a clear need for federal data privacy legislation to replace data privacy laws that vary considerably from state to state, for certain states such as California, it would mean a watering down of their current privacy protections for state residents. For instance, the SECURE Data Act does not include a private cause of action, which means individuals whose privacy is violated would not be able to sue for SECURE Data Act violations.
The SECURE Data Act has been criticized for failing to implement meaningful privacy protections and weakening protections for consumers in states that have placed limits on the collection, use, and sharing of consumers’ data. Critics say the legislation ultimately protects corporations and big tech firms rather than protecting consumers’ privacy. “We should be protecting the little guy with a bill that empowers consumers, not one that pre-empts consumer protections at the behest of Big Tech,” said Energy and Commerce Ranking Member Frank Pallone (D-NJ).
Some privacy groups have criticized the bill for important omissions, such as failing to address AI-related privacy harms. There are no provisions limiting the data that can be collected on consumers for training AI algorithms, and while companies are required to disclose if they are using AI-based automated decision-making systems, consumers do not have the right to opt out.
There are grave concerns that if enacted, it will allow big tech firms to continue collecting and using vast amounts of consumer data. “It places the onus on regular people to wade through reams of privacy policies and ask tech companies to stop abusing our data, and it leaves us without real recourse — even blocking us from going to court — if our requests go unanswered. On top of that, the bill would entirely destroy the work that states have been doing for years to protect their residents,” said American Civil Liberties Union attorney Cody Venzke.
While previous efforts to pass a comprehensive federal data privacy law, such as the American Data Privacy and Protection Act (ADDPA), have been bipartisan, bicameral, and have proposed stronger privacy protections, they have all failed to be enacted. While there is a good chance that the SECURE Data Act would be passed by the House of Representatives, it may be difficult, in its current form, for the bill to survive a Senate vote.
The post House Republicans Make New Attempt to Introduce Federal Data Privacy Legislation appeared first on The HIPAA Journal.
Alabama Ophthalmology Associates Data Breach Settlement Gets First Nod – The HIPAA Journal
Alabama Ophthalmology Associates Data Breach Settlement Gets First Nod
Alabama Ophthalmology Associates, P.C., has settled a class action lawsuit that was filed in response to a January 2025 cyberattack on its computer systems. The intrusion was identified on January 30, 2025, and the forensic investigation confirmed unauthorized access to its network between January 22 and January 30, 2025.
The hackers had access to files containing names, dates of birth, Social Security numbers, medical record numbers, treatment information, medical history information, and health insurance information. The Alabama Ophthalmology data breach affected 131,576 individuals, and notification letters were mailed in April 2025. Multiple class action lawsuits were filed in response to the data breach, which were consolidated as they had overlapping claims – In re Alabama Ophthalmology Associates, P.C., Data Breach Litigation – in the Circuit Court of Jefferson County, Alabama.
The consolidated lawsuit alleged that the defendant failed to implement reasonable and appropriate safeguards to protect sensitive data on its network, resulting in unauthorized access and exposure of patient data, and failed to issue adequate breach notifications. The lawsuit asserted claims for negligence, negligence per se, breach of contract, breach of implied contract, breach of fiduciary duty, breach of confidence, invasion of privacy, fraud, misrepresentation, unjust enrichment, bailment, wantonness, and failure to provide adequate notice pursuant to any breach notification statute or common law duty.
The defendant denies all claims and contentions in the lawsuit and maintains that there was no wrongdoing and that there is no liability. To avoid further legal costs and the uncertainty of a trial, all parties explored early resolution of the lawsuit, and a settlement was ultimately agreed upon that was acceptable to all parties.
Class members are entitled to claim two years of medical data monitoring and identity theft protection services, plus one of two cash payments. A claim may be submitted for documented, unreimbursed losses due to the data breach up to a maximum of $5,000 per class member, or a claim may be submitted for an alternative pro rata cash payment, the value of which will depend on the number of valid claims received. The cash payments are expected to be around $60 per class member. The deadline for objection and exclusion is June 5, 2026. Claims must be submitted by June 25, 2026, and the final fairness hearing has been scheduled for July 6, 2026.
The post Alabama Ophthalmology Associates Data Breach Settlement Gets First Nod appeared first on The HIPAA Journal.
OCR Fines Four Regulated Entities for HIPAA Violations That Led to Ransomware Attacks – The HIPAA Journal
OCR Fines Four Regulated Entities for HIPAA Violations That Led to Ransomware Attacks
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has announced four financial penalties to resolve potential HIPAA violations discovered during investigations of ransomware-related data breaches. The ransomware attacks resulted in the exposure of the electronic protected health information (ePHI) of 427,000 individuals, and $1,165,000 in financial penalties were imposed to resolve the HIPAA violations. In each case, the HIPAA-regulated entity agreed to pay a lower penalty to settle the alleged violations informally and agreed to adopt a corrective action plan to address the noncompliance issues identified by OCR’s investigators. Including these four settlements, OCR has resolved six investigations with financial penalties in 2026, collecting $1,278,000 in penalties.
Financially motivated cyber actors target the healthcare and public health sector, often using ransomware to encrypt files to prevent access to critical data. Threat actors know that healthcare organizations store large volumes of sensitive data and rely on access to the data to provide healthcare services. Without access to medical records, patient safety is put at risk, so victims are more likely that organziations in other sectors to pay the ransom demands to recover quickly. In addition to encryption, sensitive data is often exfiltrated and used as leverage. If the ransom is not paid, the data is sold or leaked online, putting the affected individuals at risk of identity theft and fraud.
In each of the past five years, more than 700 data breaches affecting 500 or more individuals have been reported to OCR, the majority of which were hacking incidents or ransomware attacks. “Hacking and ransomware are the most frequent type of large breach reported to OCR,” said OCR Director Paula M. Stannard, in an announcement about the HIPAA penalties. “Proactively implementing the HIPAA Security Rule before a breach or an OCR investigation not only is the law but also is a regulated entity’s best opportunity to prevent or mitigate the harmful effects of a successful cyberattack.”
One of the most important requirements of the HIPAA Security Rule is a risk analysis, the purpose of which is to identify all risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI. Those risks and vulnerabilities must then be subjected to risk management processes to eliminate them or reduce them to a low and acceptable level. If a risk analysis is not conducted, is not conducted regularly, or is incomplete, risks and vulnerabilities are likely to remain unknown and unaddressed and can be exploited to gain access to internal networks and ePHI.
OCR has made the risk analysis provision of the HIPAA Security Rule an enforcement priority due to its importance, and that initiative is being extended to include risk management. If a data breach is reported or if a complaint is submitted about an unreported data breach, OCR will investigate and will require evidence to show that a risk analysis has been completed and risks have been managed in a timely manner. In each of the four latest enforcement actions, OCR identified risk analysis failures.
In order to complete a comprehensive and accurate risk analysis, HIPAA-regulated entities must identify all locations within the organization where ePHI is located, including how ePHI enters, flows through, and leaves the organization’s information systems. It is therefore essential to create and maintain an accurate and up-to-date asset inventory on which the risk analysis can be based.
In addition to identifying and managing risks and vulnerabilities, HIPAA-regulated entities must ensure that appropriate cybersecurity measures are implemented, including access controls and authentication to restrict access to ePHI to authorized users only. Audit controls must be implemented to record and examine activity in information systems, and logs of information systems activity need to be regularly monitored. Encryption should be implemented to protect ePHI at rest and in transit, and an incident response plan must be developed, implemented, and maintained to ensure a fast response in the event of a successful intrusion. OCR also reminds regulated entities to ensure that workforce members are provided with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.
Assured Imaging Affiliated Covered Entities – $375,000 HIPAA Penalty
The largest financial penalty announced this month resolved potential HIPAA violations identified by OCR during an investigation of a ransomware-related data breach at Assured Imaging Affiliated Covered Entities (Assured Imaging), a medical imaging and screening service provider with corporate headquarters in Arizona and California. The ransomware attack was discovered on May 19, 2020, and involved the theft of ePHI such as names, contact information, dates of birth, diagnosis and conditions, lab results, medications, and treatment information of 244,813 individuals.
Assured Imaging was unable to provide evidence that a risk analysis had ever been completed. OCR determined that there had been an impermissible disclosure of the ePHI of 244,813 individuals, and that Assured Imaging failed to notify the affected individuals within 60 days, as required by the HIPAA Breach Notification Rule. OCR imposed a $375,000 financial penalty to resolve the alleged HIPAA violations, and the settlement agreement includes a comprehensive corrective action plan. Assured Imaging will be monitored for compliance with the corrective action plan for two years.
Regional Women’s Health Group, dba Axia Women’s Health – $320,000 HIPAA Penalty
Regional Women’s Health Group, which does business as Axia Women’s Health and provides women’s healthcare services to patients in New Jersey, Pennsylvania, Ohio, Indiana, and Kentucky, reported a ransomware-related data breach to OCR in December 2020. The ePHI of 37,989 individuals stored in its electronic medical record database was exposed or stolen in the incident, including names, addresses, dates of birth, SSNs, driver’s license numbers, diagnoses or conditions, lab results, and medications.
OCR determined that Axia Women’s Health had failed to conduct a comprehensive and accurate risk analysis to identify risks and vulnerabilities to ePHI and imposed a $320,000 financial penalty. Axia Women’s Health opted to settle the alleged violation informally and agreed to implement a comprehensive corrective action plan and will be monitored for compliance with that plan for two years. In addition to conducting a risk analysis, implementing a risk management plan, and providing training to the workforce, Axia Women’s Health is required to implement a process for evaluating environmental and operational changes that affect the security of ePHI, suggesting OCR found potential noncompliance in this area, in addition to the risk analysis failure.
Star Group, L.P. Health Benefits Plan – $245,000 HIPAA Penalty
Star Group, L.P. Health Benefits Plan (SG Health Plan), the self-funded employee benefits plan of a Connecticut-based energy provider, reported a ransomware attack to OCR in October 2021. The forensic investigation determined that the ransomware group exfiltrated files containing the ePHI of 9,316 of its plan members. Data stolen in the attack included names, addresses, dates of birth, SSNs, and health insurance information, such as member identification numbers, claims data, and benefit selection information.
OCR’s investigation determined that SG Health Plan had failed to conduct an accurate and thorough assessment of the risks and vulnerabilities to ePHI, resulting in an impermissible disclosure of the ePHI of 9,316 individuals. OCR resolved the alleged HIPAA violations with a $245,000 financial penalty, and SG Health Plan agreed to adopt a corrective action plan to address the alleged HIPAA violations. SG Health Plan will be monitored for compliance with the plan for 2 years.
Consociate, Inc., dba Consociate Health – $225,000 HIPAA Penalty
Consociate, Inc., doing business as Consociate Health, a third-party administrator of employee-sponsored benefit programs and business associate of health plans, discovered on January 14, 2021, that data in its information systems had been encrypted in a ransomware attack. The forensic investigation determined that its network had first been compromised 6 months previously as a result of a phishing attack.
The threat actor gained access to a server containing the ePHI of 136,539 individuals, including names, addresses, dates of birth, driver’s license numbers, Social Security numbers, credit card/bank account numbers, and diagnoses or conditions. OCR determined that Consociate Health failed to conduct an accurate and thorough risk analysis and resolved the alleged HIPAA violation with a $225,000 financial penalty. Consociate Health agreed to adopt a corrective action plan to address the alleged HIPAA violation and will be monitored for compliance with the plan for 2 years.
The post OCR Fines Four Regulated Entities for HIPAA Violations That Led to Ransomware Attacks appeared first on The HIPAA Journal.