Partner Colin Zick recently spoke at the MaHIMA Dot Wagg Memorial Legislative Seminar on HIPAA updates. Click here to download the slides. Topics included: HIPAA FAQs on right of access, CMS interoperability and the patient access proposed rule, HIPAA enforcement trends, the proposed AKS safe harbors, and more. More
Category Archives: Healthcare Industry Spotlight
A recent report from the Mass Digital Health Council includes a cybersecurity toolkit created by MDHC’s Cybersecurity Group of Experts (CGE). The toolkit will enable faster clinical adoption of new digital health products, software and solutions by enhancing access to security needs and requirements and will address:
- Cybersecurity needs for digital health companies
- Medical device and software solutions
- Best practices
- Available state and national resources and tools
This toolkit should enable healthcare organizations to share experiences and guidance with each other,… More
Today, in the first settlement of its kind, the Office for Civil Rights at the U.S. Department of Health and Human Services (“OCR”) announced that Bayfront Health St. Petersburg (“Bayfront”) has paid $85,000 to OCR and has adopted a corrective action plan to settle a potential violation of the right of access provision of the Health Insurance Portability and Accountability Act (HIPAA). This is also the first enforcement action under OCR’s Right of Access Initiative,… More
In a Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties issued on April 23, 2019, the Department of Health and Human Services (HHS) exercised “its discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as such provision was amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act” to reduce the maximum annual fines it will impose for HIPAA violations.… More
The main role of the EDPB – which succeeded the Article 29 Working Party – is to contribute to the consistent application of the GDPR throughout the European Union. Its tasks include providing general guidance to clarify the law and advising the European Commission on data protection issues and new legislations.… More
The concept that one is known by the company one keeps dates back to ancient times (the particular phrase is attributed to both Aesop and the Book of Proverbs). But this simple aphorism continues to be true. A recent example is the $500,000 that Advanced Care Hospitalists (ACH) had to pay to the Office for Civil Rights of the U.S. Department of Health and Human Services (OCR) to settle potential violations of the HIPAA Privacy and Security Rules.… More
The Cost of a Free Press: Allergy Practice Pays $125,000 to Settle Physician’s Disclosure of Patient Information on TV
Allergy Associates of Hartford, P.C. (“Allergy Associates”), has agreed to pay $125,000 to the Office for Civil Rights (“OCR“) at the U.S. Department of Health and Human Services (“HHS”) and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule. Allergy Associates is a health care practice that specializes in treating individuals with allergies, and is comprised of three doctors at four locations across Connecticut.… More
Article by James Swann
A recent hack of Obamacare enrollment records might result in a full-blown privacy investigation of the government agency that is responsible for the federal health-care exchange and serve as a wake-up call to the government.
In a recent decision from the District of Massachusetts, the alleged perpetrator of cyber-attacks against Wayside Youth and Family Support Network and Boston Children’s Hospital (“BCH”) failed in his attempt to assert a novel defense: necessity. In what most would view as a positive development, the court found that the defendant and alleged hacker did not “offer competent evidence that it was objectively reasonable to anticipate a causal relationship between the alleged cyber attack and the purported harm to be averted.”… More
The Interplay of HIPAA, Privacy and Data Security Principles, and Health Information Interoperability
It was my pleasure yesterday to speak at MedInnovation Boston 2018, and deliver a presentation on “The Interplay of HIPAA, Privacy and Data Security Principles, and Health Information Interoperability“. With constantly evolving technology and the new GDPR legal framework. achieving interoperability seems harder than ever. More
It is the last day of Bio 2018 and I am attending a curiously titled session: Is Biotechnology Drowning in Health Related Data? The panel’s answer to that question is “no” — in fact, they all agreed there isn’t enough data yet, if we want to achieve “convergence”. That’s the new buzz word: convergence. One speaker described it as “a better quantification of humanity.” … More
It took three days, but I finally found a panel at BIO 2018 that addressed the current challenges in privacy and security regarding health data. This panel, Realizing the Potential of Clinical and Consumer Genomics, was focused on all the new genetic tests that are available (with more to come) and all the genetic data those tests are generating. I was particularly impressed with the approach of Mindstrong Health to privacy and security,… More
The late rapper known as The Notorious B.I.G. recorded a song called, “Mo Money, Mo Problems.” Many of the lyrics can’t be repeated here, but the refrain can:
“It’s like the more money we come across
The more problems we see.”
I am attending BIO 2018 in Boston, just steps from our Boston office. Naturally, I was drawn to yesterday’s session on “Life Sciences Cyber Exposures and Risk Mitigation Considerations.” But I came away disappointed. First of all, the session was held in a small room and even then, it was only one-third full (maybe 30 people of the 16,000 attending BIO 2018 chose to attend).… More
Partner Colin Zick Speaks to Bloomberg BNA About the Privacy Concerns of Ride-sharing and Healthcare
Reproduced with permission from Bloomberg Law: Health IT Law & Industry Report, (March 9, 2018). Copyright 2018 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
By James Swann
Privacy and security concerns are mounting as Uber and Lyft break into the medical transportation space.
The two companies recently rolled out separate initiatives to drive patients to and from medical appointments,… More
There seems to be a new scientific study published every day—like this one that alleges that eating cheese every day might actually be healthy. Understandably, many of these studies fly under the radar — but two recently published reports regarding cybersecurity and health care should not. These two reports show that the healthcare industry in particular is continuing to struggle with cybersecurity issues. Understanding the vulnerabilities revealed by these studies is important to healthcare organizations attempting to reduce their cybersecurity risks and legal liabilities.… More
Reproduced with permission from Bloomberg Law: Privacy & Data Security, (Jan. 18, 2018). Copyright 2018 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
By James Swann
The federal government has identified two new cyberthreats that put patients’ personal data at risk for exposure.
The threats, known as Spectre and Meltdown, exploit a vulnerability in many commercial computer chips underpinning health-care computer networks,… More
On December 19, the US Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) released a report indicating continued cybersecurity vulnerabilities among HHS’ four operating divisions based on FY 2016 penetration testing. According to the report, OIG “determined that security controls across the four HHS OPDIVs needed improvement to more effectively detect and prevent certain cyberattacks” and “identified configuration management and access control vulnerabilities.”
OIG provided HHS with a restricted “rollup” report of the four operating divisions,… More
HHS Office for Civil Rights Issues Guidance on How HIPAA Allows Information Sharing to Address the Opioid Crisis
Following President Trump’s declaration of a nationwide public health emergency regarding the opioid crisis, the HHS Office for Civil Rights has released new guidance on when and how health care providers can share a patient’s health information with his or her family members, friends, and legal personal representatives when that patient may be in crisis and incapacitated, such as during an opioid overdose.
This guidance reveals nothing new,… More
Interesting viewpoints from this Journal of the American Medical Association article on FDA’s August 2017 notice re: cyber security issues with certain pacemakers, including:
- “This first widespread cybersecurity advisory involving a permanent medical device implant provides some insight into the ways in which the public experience with these types of medical device malfunctions might be improved.”
- “Communications regarding widely used products for which multiple vendors exist in the marketplace should serve as opportunities to highlight current FDA and industry standards,…
Editors’ Note: This is the first of a multi-part end-of-year series examining important trends in data privacy and cybersecurity during the coming year. Up next: the emerging threat landscape.
Like many things in Washington, the HIPAA landscape in 2018 will be shaped by the shifting priorities of President Trump’s new administration. Early signs point to less funding for the Office of Civil Rights (“OCR”) within the Department of Health and Human Services,… More
General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)
This is the third post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses. (Links for Part One and Part Two)
GDPR Features that Apply Specifically to the Healthcare/Life Science Sectors
Even though the GDPR is a general regulation,… More
General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)
This is the second post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses. (Links for Part One and Part Three)
New General Features of the GDPR
Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors.… More
General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)
This is the first post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses. (Links for Part Two and Part Three)
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE (“the Directive”).… More
In the wake of several executive orders on immigration, ICE—the federal agency responsible for enforcing the nation’s immigration laws—has ramped up enforcement activities. As a result, local public school districts and health care providers in Massachusetts have asked the Attorney General about their rights and obligations with respect to the undocumented students and patients they serve. On May 22, 2017, the AG issued comprehensive guidance to answer their questions.… More
The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center (NCCIC). Christopher Wlaschin, Chief Information Security Officer at HHS, announced this development at the 2017 ACT-IAC Health IT-Mobile Forum on April 20. According to Wlaschin, the new center, to be called the Health Cybersecurity and Communications Integration Center (HCCIC) would seek to reduce the extensive “noise” in the health care industry about cyber threats and to analyze and “deliver best practices and the two or three things that a small provider,… More
On February 16, 2017, HHS OCR announced that Memorial Healthcare Systems (MHS) had paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of HIPAA’s Privacy and Security Rules and agreed to implement a “robust” three year corrective action plan and resolution agreement. Why did MHS pay so much? A long-term failure to close security holes that led to identity theft and fraudulent tax returns.… More
Written by James Swann | This article was originally published in Bloomberg BNA Health Care Daily Report
An Illinois health system has reached a $475,000 settlement over allegations it waited too long to report a data breach, the first time the government has settled over untimely breach notifications.
Presence Health uncovered a data breach on Oct. 22, 2013 affecting 836 individuals,… More
We all assume that our genetic information is personal and private. This may not be totally correct, but that assumption goes completely out the window when you are an identical twin. This question is explored in an interesting article in the Journal of Genetic Counseling. The twins were interviewed in the MIT Technology Review. More
More information from HHS OCR about the phishing threat:
- On November 28, 2016, the HHS Office for Civil Rights issued a listserv announcement warning covered entities and their business associates about a phishing email that disguises itself as an official communication from the Department. The email prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program,…
This alert just in from HHS OCR:
“It has come to our attention that a phishing email is being circulated on mock HHS Departmental letterhead under the signature of OCR’s Director, Jocelyn Samuels. This email appears to be an official government communication, and targets employees of HIPAA covered entities and their business associates. The email prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy,… More
As part of the ongoing HHS OCR HIPAA audit initiative, it is conducting “HIPAA desk audits.” These audits don’t involve auditors coming in your facility. Instead, covered entities are being asked to submit documents on:
(1) their risk analysis and risk management plans under the HIPAA security rule;
(2) the content and timeliness for following the HIPAA breach notification rule; or
(3) the notice of the entity’s privacy practices for health information and patients’… More
The year ahead promises to be a busy one for those with responsibility for HIPAA compliance, as the Office of Civil Rights (OCR), charged with enforcing HIPAA, continues to lean in to compliance initiatives and addresses new questions in the rapidly-evolving healthcare information technology environment.… More
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
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
In Case You Missed It: Court certifies class in suit against Apple. On July 15, 2016, U.S. District Judge Jon S. Tigar certified a class of users of the mobile app Path, who allege that Apple facilitated the app’s access their contacts without their knowledge. In the same decision, Judge Tigar denied certification to a proposed class of consumers who downloaded the app, but never had their contacts uploaded. … More
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
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
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
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
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
Written by Elizabeth Snell | This article was originally published on HealthITSecurity.com
The recently announced OCR HIPAA audits are not a cause for panic, according to experts, especially of organizations have proper documentation.
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,…
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?
You have seen all the hysterical headlines — “The HIPAA audits are coming, the HIPAA audits are coming….” But when you really think about it, what is the big deal? If you are a HIPAA covered entity, you surely know by now what you are supposed to be doing. And you probably have been doing it– so just check around to make sure before you get the dreaded letter from HHS OCR. … 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
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
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 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
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
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
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:
- Companies are only as secure as their most vulnerable employee.…
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
Our friends at Co3Systems and IOD recently produced a webinar, “Ready or Not, Here They Come: Preparing For Phase 2 HIPAA Compliance Audits” that provides a succinct overview of what is coming down the pike for HIPAA covered entities.
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
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.
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
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
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
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
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.
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.
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
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
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
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
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, HITECH) and Massachusetts law. 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
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.
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
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.
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 &…
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
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
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
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 individuals also made up less than one percent of reports,… More
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.
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
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 8, there are surely over 300 breaches that have now been reported.… More
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
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 detailing and “data mining”… More
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
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.
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 companies for use in marketing to those physicians. …
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. More
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. More
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 and past enrollees nationwide are missing, including records for more than 622,000 enrollees in Health Net products regulated by the DMHC,… More
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
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 Center of the AMA and the State Medical Societies,… 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”)."
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
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 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
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;…
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
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
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 “banks, credit card companies and mortgage lenders,” according to AMA President-elect Cecil B.… More
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 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 talks about the specific problems associated with data security on peer-to-peer file sharing networks.… More
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
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
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.
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