Triple-S Salud Inc., a Puerto Rican health insurer, has been hit with a $6.8 million penalty from the Office of Civil Rights of the Department of Health and Human Services for a massive data breach. Triple-S (known as ASES in Spanish) has posted a notice on its website regarding the breach. The penalty, which also […]
Category Archives: Healthcare Industry Spotlight
On February 20, the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) released new guidance explaining how the HIPAA Privacy Rule operates to protect individuals’ privacy rights with respect to their mental health information and in what circumstances the Privacy Rule permits health care providers to communicate with patients’ family […]
A recent article in Law360 discusses how “technical problems plaguing the Affordable Care Act’s online insurance marketplace could expose vast amounts of personal data to theft….” I noted in that article that while these concerns were valid, they are simply expanded versions of existing exposures in payor databases: “Will breaches and improper disclosures happen as part of […]
HHS OCR Issues HIPAA Guidance on Refill Reminders, Decedent Information, Disclosure of Proof of Student Immunications and Delays CLIA Lab Enforcement
Late last night, HHS OCR issued its anticipated guidance on “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.” A new “Fact Sheet” and corresponding “Frequently Asked Questions” attempt to explain how the refill reminder exception to the marketing rule works, and seek to […]
You may have seen the recent lawsuit alleging that HIPAA’s marketing regulations are unconstitutional. In that case, the plaintiff is a company that “provides a refill reminder service and other adherence messaging services,” Adheris, Inc. Adheris sued the Department of Health and Human Services because HIPAA’s regulations threaten to put it out of business. In […]
The revised HIPAA regulations were formally published today in the Federal Register. In this form, they only take up 138 pages! Law360 has a brief piece on the revised HIPAA rules, with the perspectives of various attorneys (including me) on the changes. While I’m not sure I agree with the quote that “This is a […]
On January 18, 2013, nearly four years after the passage of the HITECH Act and its amendments to HIPAA, and nearly three years after it proposed regulatory amendments, the U.S. Department of Health and Human Services (“HHS”) has finally issued major “omnibus” revisions to HIPAA’s privacy and security regulations. In the 563 pages of the regulations and related regulatory comments, […]
Nearly four years after the passage of the HITECH Act and its amendments to HIPAA, and nearly three years after it proposed regulatory amendments, the U.S. Department of Health and Human Services (“HHS”) has finally issued major revisions to HIPAA’s privacy and security regulations. While we are still making our way through all 563 pages of the regulations and related regulatory comments (and will […]
Massachusetts Attorney General Secures $140,000 Settlement of Claims that Patient Information Was Left in a Town Dump
The Massachusetts Attorney General announced today that the former owners of a medical billing practice and four pathology groups have agreed to collectively pay $140,000 to settle allegations that medical records and patient billing information for “tens of thousands of Massachusetts patients were improperly disposed of at a public dump.” Under the settlements, the defendants have agreed to pay a […]
The Department of Health and Human Services’ Office for Civil Rights (“HHS OCR“) announced today that it was, for the first time, entering into a monetary HIPAA settlement for a breach involving less than 500 patients: the Hospice of North Idaho (HONI) has agreed to pay HHS OCR $50,000 to settle potential HIPAA security rule violations. HHS OCR began its investigation after HONI reported to […]
Today’s Law360 addresses “HHS Data-Scrubbing Guidance” with quotes from me and others on the subject: Clarifying the types of data that need to be removed from data sets can also help companies maximize the value of the information that they hold as the value of and ability to use this data for research and public […]
On November 26, HHS OCR released guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule. This guidance fulfills the American Recovery and Reinvestment Act of 2009 (ARRA) mandate that HHS issue such guidance. Following the passage of ARRA, OCR collected research and views regarding de-identification approaches, best practices for […]
It was a pleasure to be on a panel with members of the Massachusetts Office of the Attorney General last week at the Massachusetts Medical Society to talk about how physicians can protect health information in our presentation entitled: ”Protecting Health Information: Health Data Security Training.” We covered the latest in federal law (HIPAA, […]
Another Massachusetts Health Care Provider Hit with Big HIPAA Settlement: Massachusetts Eye and Ear Infirmary Pays $1.5 Million
Late yesterday, the HHS Office for Civil Rights (“OCR”) announced that it had reached a $1.5 million settlement with Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. (“MEEI“) to settle potential HIPAA Security violations. As part of the settlement, MEEI also agreed to a Corrective Action Plan to improve policies and procedures to safeguard the privacy and security […]
A recent Harris Interactive survey of 2,625 adult Americans reveals some interesting attitudes towards employer confidential information, including significant variations depending on an employee’s age: – 68% of 18-34 year olds responded that it is acceptable to remove confidential information from their place of employment. This contrasts with just half (50%) of those 55 years […]
With relatively little fanfare, Massachusetts Governor Deval Patrick signed S.2158, into law on April 27, 2012, making HIV testing possible with simply verbal consent, as opposed to written consent. The legislation amends Mass. Gen. L. ch. 111, section 70F; its aim is to increase screening for HIV and I believe it will have that effect. Will […]
As you may recall, the Health Information Technology for Clinical and Economic Health (HITECH) Act gives state Attorneys General the authority to bring civil actions on behalf of state residents for violations of the HIPAA Privacy and Security Rules. Some states, like Massachusetts, have already started to use this authority to bring and settle cases. To […]
Data Breaches Continue To Be A Problem For Health Care Providers: South Shore Hospital (Massachusetts) Pays $750,000 To Settle Data Breach Charges
An aptly-timed article from Mass High Tech Business News noted earlier today that: “Data Breaches [Are] a Growing Problem in Health Care.” This article focused on a recent breach at Boston Children’s Hospital involving the records of 2,000 patients. The article was prescient, as this afternoon, the Massachusetts Attorney General announced a $750,000 settlement with suburban Boston’s […]
ONC (“Office of the National Coordinator for Health Information Technology”) Issues Guide to Privacy and Security of Health Information
The Office of the National Coordinator for Health Information Technology (“ONC”) has issued a Guide to Privacy and Security of Health Information Guide to Privacy and Security of Health Information. The guide is targeted at smaller health care providers and their administrative staff members. The 47 pages contain five chapters: Chapter 1: What Is Privacy […]
In an article that repeats a common theme in this space, this week’s Economist talks about how researchers are trying to help ordinary people toughen up their passwords. But despite the efforts of these researchers, the article’s conclusion is a gloomy one: The upshot is that there is probably no right answer. All security is […]
A recent issue of the Journal of the American Medical Association takes on the issue of physician medical identify theft; here’s the abstract: It took several months for one physician to learn that she was a victim of medical identity theft. This realization occurred after patients reported that her name was on their Medicare Summary […]
$1.5 Million Settlement of First HIPAA Enforcement Action Resulting from HITECH Breach Notification Rule
The trend toward increasingly large health information breach settlements has continued with yesterday’s announcement thatBlue Cross Blue Shield of Tennessee (BCBST) has agreed to pay the U.S. Department of Health and Human Services (HHS) $1,500,000 to settle potential violations of HIPAA’s Privacy and Security Rules, HHS’s Office of Civil Rights. BCBST also agreed to a corrective […]
An Atlanta, Georgia man was sentenced earlier this month to one year and one month in prison for intentionally accessing a computer of a competing medical practice, and taking personal information of the patients. The individual made this improper access in order to send marketing materials to patients at the other practice. The individual worked as an information technology […]
In its recent Annual Report to Congress on Breaches of Unsecured Protected Health Information, the Office of Civil Rights of the Department of Health and Human Services, we see confirmation of certain trends– bigger breaches and breaches involving theft of electronic media: Between January 1, 2010 and December 31, 2010, breaches involving 500 or more […]
This report from the Office of the Inspector General for the Department of Health and Human Services reveals significant holes in Medicare contractor security. Here’s a notable excerpt: Security Awareness Training The Computer Security Act of 1987 (P.L. No. 100-235) requires periodic training in computer security awareness and accepted computer practices for all employees who […]
“Once More Unto the Breach, Dear Friends, Once More”: The Increasing Recognition of Complexity in Data Breach Response and Reporting
In an article in today’s New York Times, we get some real-life insight into the difficulties in responding to a data breach. Even simple questions, like whether or not to report the breach and who is responsible for reporting it, take on unforeseen complexity. The particular breach in question happened at the Massachusetts eHealth Collaborative, when an employee’s […]
A recent Massachusetts case shows that even prisoners have a right to privacy in their medical records. In this case, Alexander v. Clark, Suffolk Superior Court, Civil Action No. 0905456-H 28 Mass. L. Rptr. No. 14, 291 (May 30, 2011), the court sided with the claim of a prisoner that her health information had been wrongfully disclosed. In particular, […]
When we last looked at OCR’s reporting on HIPAA breaches impacting 500 or more individuals, back in May 2011, there had been 265. This was up from September 2010, when there had been 191 such breaches. As of today, there as 292 listed. Given that the last reported date of breach on the OCR’s list is May […]
In another sign that OCR is continuing to seek significant penalties for HIPAA violations, it announced on July 7 that the UCLA Health System ("UCLAHS") has agreed to settle potential violations of the HIPAA Privacy and Security Rules for $865,500 and has committed to a corrective action plan aimed at remedying gaps in its compliance with […]
As promised in our earlier entry, here is our detailed discussion of the Supreme Court’s decision in Sorrell v IMS Health, Inc.,written by Colin J. Zick, Pat A. Cerundolo, Tad Heuer On Thursday, June 23, the United States Supreme Court voted 6-3 to strike down a Vermont statute that sought to impose significant restrictions on pharmaceutical […]
The Supreme Court this morning voted 6-3 to strike down a Vermont statute that sought to impose significant restrictions on pharmaceutical data mining activities. Justice Kennedy’s opinion in the closely-watched case of IMS v. Sorrell held that the Vermont statute was an unconstitutional regulation of commercial speech. The first paragraph of Justice Kennedy’s opinion provides a […]
The case of Dr. Alexandra Thran should cure any physician of the desire to discuss a patient on Facebook. Dr. Thran has been reprimanded by her state’s Medical Board and lost her emergency room privileges. Although the posting in question did not list the patient’s name, Dr. Thran provided enough details so that at least one other person could identify […]
I give my perspective on issues of physician privacy in this video from The HealthCare Channel, including: Can physicians challenge online review sites such as Health Grades or Vitals.com to have critical patient comments removed? The Supreme Court will rule soon on the case against the State of Vermont and the law banning the sale of prescription data to […]
When we last looked at OCR’s reporting on HIPAA breaches impacting 500 or more individuals, back in September 2010, there had been 191 such breaches. In the intervening 7 months, that number has jumped to 265 such breaches listed on OCR’s website. It’s safe to expect these figures will continue to climb for the foreseeable future.
Earlier today, I delivered a presentation on "Data Security and Privacy for Medical Device, Pharmaceutical and Life Sciences Companies: How to manage your obligations under HIPAA, the HITECH Act and other federal and state data privacy and security laws" with colleagues Ara Gershengorn and Sarah Altschuller.
On March 14, the California-based managed care organization, Health Net, Inc., announced that it cannot account for "several server drives" that contained protected health information. According to California regulators, these servers appear to contain the data of 1.9 million people nationwide: The company announced today that nine of its server drives containing personal information for 1.9 million current […]
As we noted earlier this month, Massachusetts General Hospital recently entered into a $1 million Resolution Agreement and Corrective Action Plan with the Department of Health and Human Services’ Office of Civil Rights. This settlement stemmed from an incident on March 9, 2009, when a MGH employee was commuting on the subway, "removed documents containing PHI from her bag and placed […]
While the effect of the federal legislation modifying the FTC Red Flags Rule has been known for a while, the court proceedings that challenged the rule have now caught up. The American Bar Association’s suit has been dismissed, and the American Medical Association announced it is voluntarily dismissing its case: "The lawsuit filed by the Litigation […]
You Call That a Password? Passwords Used to Protect Personal Health Information in Clinical Trials Are Cracked More Than 90% of the Time
In a recent article in the Journal of Medical Internet Research, the strength of passwords in clinical trials was analyzed. In all cases that were examined, "the recovered passwords were poorly constructed, with names of local locations (e.g., “ottawa”), names of animals (e.g., “cobra”), car brands (e.g., “nissan”), and common number sequences (e.g., “123”)." This result […]
Earlier today, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a Notice of Final Determination finding that Cignet Health of Prince George’s County, Md., (Cignet) violated the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HHS imposed a civil money penalty (CMP) of […]
500 Is a Magic Number: Health Information Breaches Impacting 499 or Fewer Patients Likely Go Uninvestigated By OCR
In the recently-released fiscal 2012 budget for HHS, a dirty little secret has been acknowledged: the Office of Civil Rights does not have the resources to review all reported breaches of health information. In fact, if you have a breach that impacts up to 499 people, you are unlikely to hear from OCR at all: Current […]
In a complaint filed with the FTC on November 23, four advocacy groups asked for "Investigation, Public Disclosure, Injunction, and Other Relief" against several online health giants, including Google, Microsoft, QualityHealth, WebMD, Yahoo, AOL, HealthCentral, Healthline, and Everyday Health. The advocacy groups behind this complaint are the Center for Digital Democracy, U.S. PIRG, Consumer Watchdog and World […]
The American Medical Association recently published a policy on "Professionalism in the Use of Social Media," in an apparent attempt to address growing concerns about patient confidentiality and privacy in various internet settings. While the policy mostly consists of "considerations" that physicians should "weigh" when maintaining an online presence (none of which are new or earth-shattering), […]
On July 8, 2010, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking (“NPRM” or “proposed rule”)1 modifying the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy, Security, and Enforcement Rules2 pursuant to the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which was enacted February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5.
I shared some of my initial thoughts about the new HITECH/HIPAA regulations with Melissa Klein Aguilar for her blog, "The Filing Cabinet," in today’s on-line edition of Compliance Week.
HHS Issues a Notice of Proposed Rulemaking to Modify the HIPAA Privacy, Security, and Enforcement Rules
Earlier today, the Department of Health and Human Services announced proposed modifications to the HIPAA Privacy Rules, calling them the most significant changes in HIPAA since 2003, when the HIPAA Security Rules were adopted. The propose changes include: provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities; […]
In late June, the Centers for Medicare & Medicaid Services (“CMS”) proposed new rules for hospitals that would entitle patients to choose their own visitors during a hospital stay, including visitors who are same-sex domestic partners. These proposed rules stem from the April 15, 2010 Presidential Memorandum on Hospital Visitation issued to the Secretary of Health and […]
On June 25, 2010, federal district court judge Reggie B. Walton of the United States District Court for the District of Columbia entered a stipulated court order (.pdf) directing the Federal Trade Commission (FTC) to delay enforcement of the FTC’s Red Flags Rule against doctors and medical practices represented by the American Medical Association (AMA) […]
Today, the Federal Trade Commission issued a press release and an Enforcement Policy extending the deadline for enforcement of the FTC’s Red Flags Rule through December 31, 2010. The agency cited requests from members of Congress for a postponement of the deadline while legislators tinker with federal law to exclude certain businesses from application of the Rule.
Earlier today, the American Medical Association, American Osteopathic Association and the Medical Society of the District of Columbia filed a complaint that seeks to block the application of the Federal Trade Commission’s Red Flags Rule to their members. According to its press release, the AMA filed this suit because it unfairly treats physician practices like […]
As part of the settlement of a federal court action, the State of Texas has agreed to destroy more than 5 million blood samples taken from babies without parental consent and stored indefinitely for the purpose of scientific research. The Texas Department of State Health Services announced earlier this week that it would destroy the […]
Massachusetts Court Holds Disclosure of Patient Records Does Not Violate HIPAA or State Consumer Statute
In Mercier v. Courtyard Nursing Care Center, 2009 WL 1873746 (Mass. Super. Ct. Jun. 11, 2009), a resident of a nursing home sued the home in Massachusetts Superior Court for negligence after being assaulted by another resident. The injured resident moved to obtain medical records maintained by the home regarding the resident who had allegedly […]
Incident of the Week: in our first double feature, we report on the recent breach announced at the University of North Carolina and the plea agreement reached with one Massachusetts inmate who hacked the prison computer system while still behind bars.
Incident of the Week: FBI Arrests Hacker Posing as Security Guard Who Infiltrated Texas Hospital Days Before “Devil’s Day” Attack
This week, the U.S. Attorney’s Office for the Northern District of Texas announced that the FBI has arrested Jesse William McGraw, a 25 year old contract security guard at the W. B. Carrell Memorial Clinic, a hospital in Dallas, Texas, for hacking the hospital’s computers and air conditioning system. For many businesses, an attack on ventilation systems might be an inconvenience, but the threat could be much more serious for critical care patients in healthcare institutions like the Carrell Clinic. McGraw is charged with violations of the Computer Fraud and Abuse Act (CFAA), 18 U.S.C. sec. 1030.
In this, the third and final part of Security, Privacy and the Law’s interview with M. Eric Johnson (Part 1 may be found here and Part 2 is here), Dr. Johnson talks about why the fragmented nature of the American healthcare system is so dangerous and why he believes greater consolidation would better protect private information. He also […]
In this, the second part of Privacy, Security and the Law’s three part interview with M. Eric Johnson (begun here), Dr. Johnson talks about why he thinks the healthcare sector is uniquely vulnerable to security breaches and what special problems that vulnerability poses.
A recent article from Computerworld reports that, according to a new study conducted by researchers from MIT and the University of Virginia, "EMR [Electronic Medical Record] adoption is often slowest in states with strong regulations for safeguarding the privacy of medical records." According to the study, in states with "strong privacy laws", the number of hospitals […]
Security, Privacy, and The Law recently had the chance to sit down with Dr. M. Eric Johnson to talk about his recent paper “Data Hemorrhages in the Health-Care Sector.” Dr. Johnson’s study has been in the news lately because many were startled by his finding that a great deal of patient healthcare information is available on peer-to-peer (P2P) file sharing networks. We are thrilled that Dr. Johnson agreed to do a interview with Security, Privacy, and The Law and we will be posting the full interview with Dr. Johnson in several parts.
First the Bad News, Your Doctor’s Lost His License; Now the Really Bad News: No One’s Taking Care of Your Records
As outlined in April 2’s Boston Globe, a Massachusetts physician who lost his license to practice is still causing problems for his patients. He left his office and records, and now his patient records are about to be destroyed unless the patients come to claim them. The state authorities claim they don’t have the resources to maintain […]
It seems an inevitable consequence of modern celebrity: when you go to the hospital, hospital workers will look at your records (even though they have no medical reason to). The latest example of this involved the infamous mother of octuplets, Nadya Suleman. It resulted in the firing of 15 hospital workers at Kaiser Permanente’s hospital in Bellflower, California. All […]
The FTC Strikes Back: (Essentially) Everyone Should Be Complying With Red Flags Rules, Especially The Healthcare Industry
In a recent letter (.pdf) to the healthcare industry, the Federal Trade Commission (“FTC”) has issued its clearest pronouncement yet on which entities must comply with federal “Red Flag Rules” — the identity theft regulations that will go into effect for many businesses on May 1, 2009 (and have been in effect for banks and financial institutions since November 1, 2008). This latest guidance strongly suggests that if you are wondering whether the new federal regulations apply to you — then they probably do. In this post, we will recap the FTC’s recent guidance on who should be complying with the Rules.
For all their problems, Veterans Affairs medical centers across the country are at the vanguard of the implementation of electronic health records. As such, there is a lot to learn from the problems that the VA system has experienced in this area. According to an article in the March 4, 2009 Journal of the American Medical Association, […]
Adding to the Patchwork: HITECH Act Sets New “Floor” for Data Breach Notification of Certain Patient Information
On Tuesday, February 17, 2009, President Obama signed into law the widely-debated federal economic stimulus package, officially titled the American Recovery and Reinvestment Act of 2009, and with it, enacted the Health Information Technology for Economic and Clinical Health Act (HITECH Act). Much of the media attention on the HITECH Act has focused on the policies […]