Category Archives: Healthcare Industry Spotlight

Sharing Consumer Health Information? Look to HIPAA and the FTC Act

Does your business collect and share consumer health information? Check out these tips from the FTC for complying with HIPAA and the FTC Act.


The HIPAA Privacy Rule applies to HIPAA covered entities— a health plan, most health care providers, or a health care clearinghouse. It also applies if you are a business associate – a person or company that helps a covered entity carry out its health care activities and functions.… More

Cybersecurity News and Notes – July 25, 2016

In Case You Missed It: U.S. Major party platforms address cybersecurity.  The two major parties have released their 2016 election platforms, both of which include cybersecurity planks.  The Republican platform’s perspective of cybersecurity is an element of national security and international relations. The platform called for harsh responses to cyber-attacks against American businesses, institutions, and government, applauded the Cybersecurity Information Sharing Act of 2015, and pledged to “explore the possibility of a free market for Cyber-Insurance.” The Democratic platform is largely as a continuation of President Obama’s cybersecurity policies.… More

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in recent months. This guidance comes in the wake of a June 20, 2016 “Dear Colleague” letter from HHS Secretary Sylvia Burwell highlighting ransomware issues. The most notable of OCR’s statements is that ransomware attacks often constitute breaches subject to the HIPAA Breach Notification Rule.… More

Bad News for HIPAA Business Associates: HHS OCR Announces $650,000 Settlement for BA Breach

Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”), a HIPAA business associate, has agreed to pay the Department of Health and Human Services Office of Civil Rights (“OCR”) $650,000 in connection with a data breach involving the nursing homes to which it provides management and IT services.

The underlying breach occurred in February 2014 (which suggests a significant backlog at OCR in resolving open matters). … More

Cybersecurity News & Notes – June 20, 2016

In Case You Missed It: Illinois strengthened its data privacy and security law, with the amendments going into effect in January 2017.  The amendments include expanding the definition of “personal information” to include a username or email address of an Illinois resident in conjunction with a password or security question answer that would permit access to an online account.  The definition is also expanded to include medical and health insurance information. … More

Ransomware Update: The FBI Weighs In

The FBI recently released an article discussing the spate of ransomware attacks on a variety of different entities, including hospitals. In the article, the FBI warned that ransomware attacks and the cybercriminals carrying them out are growing increasingly sophisticated.  The FBI opposes paying a ransom when hit by a ransomware attack, saying that doing do incentivizes more ransomware attacks, can inadvertently fund other illegal activity, and does not always result in the restoration of access. … More

OCR Releases Video Guidance on Provision of Medical Records

The summer movie season is now officially in full swing, with the release of three informational videos regarding HIPAA and the right of individuals to access their medical records, published by the Office of Civil Rights of the Department of Health and Human Services. 

The video trilogy, and accompanying infographic, are the eagerly-awaited sequel to OCR’s guidance “Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.525,” issued earlier this year. … More

Watch: HIPAA Crimes Webinar – How the New Crime Wave Affects You

Unfortunately, health care providers are the perfect mark for theft and extortion because they have huge amounts of sensitive information and maintain such information in computer databases at risk of infiltration. On May 17, Foley Hoag presented a webinar discussing the ongoing crime sprees involving theft of patients’ identities and health information; ransomware involved in these crimes; related data security issues affecting health care providers; and how they implicate law enforcement and the criminal law aspects of HIPAA.… More

Top Tips for OCR HIPAA Audit Preparation

Written by Elizabeth Snell | This article was originally published on 

The recently announced OCR HIPAA audits are not a cause for panic, according to experts, especially of organizations have proper documentation.

With the most recent round of OCR HIPAA audits announced just last month, many healthcare organizations are working to ensure that they are prepared should they be called for investigation.… More

EU General Data Protection Regulation Adopted

After years of intense discussions, the EU General Data Protection Regulation (GDPR) was finally adopted on 14 April 2016.

The GDRP sets out uniform new rules in the field of data protection across the EU, rules that will standardize the law in the 28 EU Member States and have an impact on both European and non-European companies.  For example:

  • data controllers (companies collecting and using personal information) will have a wide range of new obligations,…
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How Hospitals Can Avoid Being the Next Ransomware Victim

Hospitals are increasingly the target of hackers, particularly in the form of “ransomware.”  What follows is a primer on ransomware and how to avoid being a target of it.

What is ransomware? 

Ransomware is a type of malware that limits users’ access to their computer systems. It functions by locking a user’s system and/or encrypting its files.… More

EU Commission and United States agree on new framework for transatlantic data flows: EU-US Privacy Shield

What follows below is the EU’s press release regarding the agreement on a replacement for the EU-US Safe Harbor.  We are working to get details and will schedule a webinar on the new framework shortly.


The European Commission and the United States have agreed on a new framework for transatlantic data flows: the EU-US Privacy Shield.

Today, the College of Commissioners approved the political agreement reached and has mandated Vice-President Ansip and Commissioner Jourová to prepare the necessary steps to put in place the new arrangement.… More

The Cybersecurity Act of 2015: Implications for Threat Sharing

On December 18, 2015, President Obama signed the Cybersecurity Act of 2015 (The “Act”), legislation designed to combat online threats to the federal government, state and local governments, and private entities. Within the Act are four titles, the most significant of which is Title I, the Cybersecurity Information Sharing Act (“CISA”) (which begins at p. 694).

CISA addresses the manner in which the federal government and non-federal entities may share information about cyber threats and the defensive measures they may take to combat those threats.… More

Massachusetts Health Information Management Association Winter Meeting: Compliance Beyond HIPAA

On January 22, 2016, I had the pleasure to present to the Massachusetts Health Information Management Association’s Winter Meeting, to discuss “Compliance Beyond HIPAA.”  The presentation slides from the program are available here, and reflect discussion of:

HIPAA Privacy Regulations Amended to Allow Disclosures of Mental Health Information for Firearm Background Checks

On January 4, 2016, the Department of Health and Human Services (HHS) modified the HIPAA Privacy Rule to expressly permit certain covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of those individuals who, for mental health reasons, already are prohibited by Federal law from having a firearm.  According to HHS, “This modification better enables the reporting of the identities of prohibited individuals to the background check system and is an important step toward improving the public’s safety while continuing to strongly protect individuals’… More

The LabMD Case: Further Defining the FTC’s Enforcement Powers

The scaffolding of the FTC’s powers in the realm of cybersecurity continues to be built.  On Monday, the FTC’s Chief Administrative Law Judge D. Michael Chappell issued an initial decision in the FTC’s closely watched enforcement action against LabMD.  The case involves a 2008 incident in which a data security company (Tiversa Holding Co.) discovered a LabMD document containing personal information of 9,300 patients was available on a P2P file sharing network. … More

Cybersecurity and Risk Management: “Navigating the Digital Age: The Definitive Cybersecurity Guide for Directors and Officers”

A timely new resource for business executives, technology professionals, and lawyers alike is the newly-published Navigating the Digital Age:  The Definitive Cybersecurity Guide for Directors and Officers from the New York Stock Exchange and Palo Alto Networks.  At 355 pages, the guide provides information from dozens of contributors from around the country and from various backgrounds. The guide explores 46 separate topics, focusing on such issues as prevention,… More

The FTC’s Broad Authority and FTC v. Wyndham: Thinking about the Future of Data Privacy Regulations

What makes data privacy law interesting for academics, challenging for lawyers, and frustrating for businesses is its shape-shifting structure in the face of rapidly changing technology.  The recent change in the invalidation of US-EU “safe harbor” system is a useful reminder of the differences between the way the European Union and the U.S. handle questions of data privacy:  whereas, generally speaking, in the EU data privacy standards are relatively uniform,… More

Federal Data Breach Bill Stalled in Congress

A key distinguishing feature of U.S. data privacy laws is their patchwork nature.  There are industry-specific data privacy laws at the federal level (think HIPAA or the GLBA), yet there are no comprehensive federal standards that governs an entity’s obligations in the event of a data breach like the EU’s Data Privacy Directive.  For data breach response, in addition to the possible application of an industry-specific law or regulation,… More

Understanding ISO 27018 and Preparing for the Modern Era of Cloud Security

This seminar was presented by Foley Hoag LLP and and a panel of industry experts on ISO 27018, the new international standard governing the processing and protection of personal information by public Cloud Service Providers (CSPs). Even though this new standard is voluntary, it is widely expected to become the benchmark for CSPs going forward.

As the first and only international privacy standard for the cloud,… More

HIPAA Compliant Technology and the Importance of Encryption

We welcome this guest blog by Gene Fry, Compliance Officer, Scrypt, Inc.

The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data. This means that any covered entity (CE) or business associate (BA) that deals with protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed. The HIPAA Privacy Rule addresses the storage,… More

Update on President Obama’s “Summit on Cybersecurity and Consumer Protection,” Part III: Five Key Lessons for Business

Concluding our three-part analysis of the White House’s first Summit on Cybersecurity and Consumer Protection, we turn to some practical advice coming out of the Summit’s afternoon session, including an address by Maria Contreras-Sweet, the administrator of the Small Business Administration (“SBA”), and a panel discussion among financial sector leaders moderated by Deputy Treasury Secretary Sarah Bloom Raskin.

Here are five takeaways for companies large and small:

  1. Companies are only as secure as their most vulnerable employee.…
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Medical Billing Provider and its Former CEO Settle FTC Charges That They Misled Consumers About Collection of Personal Health Data

In an age when many of us briskly scroll through website terms and conditions and check, “I agree” without thinking, how should businesses design their websites to obtain proper authorization to access users’ sensitive information? The announcement of the settlement of a pair of recent FTC complaints against PaymentsMD, a medical billing services provider and its former CEO, and the resulting settlement, provide some important guidance,… More

Don’t Put Off That New HIPAA Business Associate Agreement: September 23, 2014 Deadline Looms

It’s been a while, but we have another HIPAA deadline just around the corner: September 23, 2014.

September 23, 2014 is the date by which all HIPAA business associate agreements need to be in compliance with the current HIPAA regulations (often called the Omnibus Rule). The current rules went into effect on March 26, 2013, but certain then-existing HIPAA BAAs were grandfathered and did not have to be updated immediately.… More

Health Insurer Hit With A Record HIPAA Penalty: What Does It Mean?

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 is described in a securities filing, is based a breach involving 13,336 of Triple-S’s Dual Eligible Medicare beneficiaries. … More

HHS OCR Issues HIPAA Guidance on Sharing Information Related to Mental Health

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 members and others to enhance treatment and assure safety.

The guidance is essentially a set of answers to frequently asked questions. … More

Security Flaws Could Land Affordable Care Act Contractors In Legal Crosshairs

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 the new federal and state exchanges? I wouldn’t bet against it,” said Foley Hoag LLP privacy and data security practice co-chair Colin Zick.… More

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 address both the scope of communications that fall within the exception,… More

HIPAA Unconstitutional? Maybe Not, But New Marketing Regulations Are Coming

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 particular, HIPAA now requires patient authorizations for its kind of patient reminders. … More

HIPAA “Omnibus” Regulations Published in Federal Register

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 paradigm shift in the privacy world,” I do agree that this is “definitely something for all businesses to pay attention to.”  Similarly,… More

The Wait Is Over! HHS Finally Issues Revised HIPAA Privacy and Security Regulations

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 have a more detailed analysis shortly in this space),… More

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 total of $140,000 for civil penalties, attorney fees,… More

HHS Announces First HIPAA Breach Settlement Involving Less than 500 Patients

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 it that an unencrypted laptop computer containing the electronic protected health information (“ePHI”) of 441 patients had been stolen in June 2010.… More

Law360: “HHS Data-Scrubbing Guidance Backs Strict Privacy Definitions”

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 health purposes increases, Foley Hoag LLP security and privacy practice co-chair Colin Zick added.… More

HHS OCR Issues Guidance Regarding Methods for De-identification of PHI in Accordance with HIPAA

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 implementation and management of the current de-identification standard and potential changes to address policy concerns.… More

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 of its patients’… More

Survey Reveals Generation Gap in Employee Attitudes Toward Confidential Information

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 old or older believing such behavior is acceptable.

–… More

The Coming Boom in HIV Testing (and Requests for Production of HIV Records)

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 the change in the law have an impact on health information management?… More

Want to Learn HIPAA Just Like Your State Attorney General? Now You Can!

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 advance state enforcement, HHS OCR has developed HIPAA Enforcement Training modules,… More

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 South Shore Hospital, relating to a 2010 data breach.… More

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 & Security and Why Does It Matter?
  • Chapter 2: Privacy &…
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Good Advice that Bears Repeating: Toughen Up Your Passwords!

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 irritating (ask anyone who flies regularly), and there is a constant tension between people’s desire to be safe and their desire for things to be simple.… More

Phyisican Medical Identify Theft — A Growing Problem?

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 Notices although they had never seen her. A fraudulent clinical practice had enrolled in Medicare using her name without her knowledge.… More

$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 action plan to address gaps in its HIPAA compliance program.… More

Jail Time for Man Who Accessed Computer of a Competing Medical Practice

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 specialist for a perinatal medical practice in Atlanta.  He separated from employment from the first practice and joined a competing perinatal medical practice, located in the same building.  He then used his home computer to hack into his former employer’s patient database. … More

Medicare Contractors Lag on Information Security

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 manage, use, or operate Federal computer systems. Additionally,… More

“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 car was broken into and a company laptop stolen. … More

Pulling Out Your Hair Over Wrongfully Disclosed Records?

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, the prisoner, Christine Alexander, sued several correction officials because those officials had sent documents regarding her “request for Propecia for hair loss”… More

Another Big HIPAA Settlement: The UCLA Health System Settles for $865,000

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 those rules.  This follows on the heels of Massachusetts General Hospital’s $1 million settlement with OCR.… More

Supreme Court Strikes Down Vermont Data Mining Law

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 brief summary of the posture of the case and of the Court’s decision:

Vermont law restricts the sale,… More

Facebook Posting about Patient=HIPAA Violation=Physician Sanctions

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 the patient. The result was irreparable damage to her career. 

In an article in the most recent Annals of Internal Medicine discussing this case, the author referred to Facebook as the “new elevator.” … More

Is Physician Privacy a Thing of the Past

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 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 companies for use in marketing to those physicians.  …
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Health Net Announces Second Major Breach in Two Years; Creates Potential for Largest Ever Penalty

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 informationAccording 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 and past enrollees nationwide are missing, including records for more than 622,000 enrollees in Health Net products regulated by the DMHC,… More

What Is Inside Mass General’s $1 Million HIPAA Settlement?

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 them on the seat beside her. The documents were not in an envelope and were bound with a rubber band.… More

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 comes as no real surprise.  These conclusions build on prior studies … More

HHS Fines Cignet Health $4.3 Million for HIPAA Violations

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 $4.3 million for the violations, representing what OCR said was "the first CMP issued by the Department for a covered entity’s violations of the HIPAA Privacy Rule." … More

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 OCR practice is to validate, post to the HHS website,… More

AMA Adopts Policy on “Professionalism in the Use of Social Media”

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), there was one notable exception — a snitch rule: 

"When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual,… More

HHS Proposes Major Changes to HIPAA Privacy, Security and Enforcement Rules

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.

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;
  • establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes;…
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CMS Issues Proposed Rules on Hospital Visitors

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 Human Services.

The proposed rules would require every hospital to have written policies and procedures detailing patients’ visitation rights,… More

FTC Delays Enforcement of Red Flags Rule Against Doctors & Hospitals Until Appeals Court Rules

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) and American Osteopathic Association.  The FTC and AMA agreed to this delay in a Joint Stipulation (.pdf),… More

ALERT: FTC Delays Enforcement of Red Flags Rule Through December 31, 2010

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.

Medical Groups Challenge June 1 Application of FTC Red Flags 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 “banks, credit card companies and mortgage lenders,” according to AMA President-elect Cecil B.… More

Texas to Destroy 5.3 Million Illegally Obtained Blood Samples

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 samples in connection with the settlement of a federal lawsuit filed in March 2009 by the Texas Civil Rights Project on behalf of five parents of children whose blood was being held for use in research without their consent.… More

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 committed the assault. The home contended that disclosure of the records would violate both HIPAA’s prohibition on disclosure of medical records without a patient’s authorization and Mass.… More

Incident(s) of the Week: Double Feature

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.

Interview with M. Eric Johnson, Part 3

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 talks about the specific problems associated with data security on peer-to-peer file sharing networks.… More

Interview with M. Eric Johnson, Part 2

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. More

New Study: Patient Privacy Rules Hamper Adoption of Electronic Medical Records

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 using EMR systems is up to 30% lower than in states with "less stringent privacy requirements." … More

Interview with M. Eric Johnson, author of “Data Hemorrhages in the Health-Care Sector”

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 the records, or to help find the patients. The auction company just wants them gone.… More

Another Day, Another Celebrity’s Hospital Record Breached

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 these violations have been reported by Kaiser to the California Department of Public Health. … More

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.

Lessons from the VA: what you can learn from someone else’s problems

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, the problems experienced by the VA include mixed-up patient names and missing medication orders. These types of problems are probably endemic in any EHR system.… More

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 promoting health information technology a topic that President Obama touted throughout his campaign. However, the HITECH Act also contains myriad regulations that expand the security and privacy provisions of the Health Information Portability and Accountability Act of 1996 ("HIPAA"),… More