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Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with a focus on patients who are at risk for cardiac arrhythmias.

In January 2012, the remote monitoring company reported that a workforce member’s laptop containing the ePHI of over a thousand individuals was stolen from a parked vehicle outside of the employee’s home. A little over one year later, the same company reported a second breach that compromised the ePHI of twice as many individuals (details regarding this breach were not provided by OCR).

OCR’s investigation revealed that the company allegedly had insufficient risk analysis and risk management processes in place at the time of the theft. Additionally, the company’s draft policies and procedures implementing the standards of the HIPAA Security Rule had never been implemented, and the company was also unable to produce final versions of any policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices.

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OCR Guidance Underscores Importance of Authentication under HIPAA

In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication method to protect electronic protected health information (ePHI). Authentication is the process used to “verify whether someone or something is who or what it purports to be and keeps unauthorized people or programs from gaining access to information.” The Newsletter notes that the health care sector has been a significant target of cybercrime and that some incidents result from weak authentication methods.

Authentication methods can consist of one or more factors and are often described as: (1) something you know, such as a password; (2) something you are, such as a fingerprint; or (3) something you have, such as a mobile device or smart card. Single-factor authentication requires use of only one of the methods. Multifactor authentication requires use of two or more methods (for example, a password prompt followed by an additional prompt to a mobile device). (more…)




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ECJ Confirms Dynamic IP Address May Constitute Personal Data But Can Be Logged to Combat Cyberattacks

On 19 October 2016, the European Court of Justice (ECJ) held (Case C-582/14 – Breyer v Federal Republic of Germany) that dynamic IP addresses may constitute personal data. The ECJ also held that a website operator may collect and process IP addresses for the purpose of protecting itself against cyberattacks, because in the view of the Court, preventing cyberattacks may be a legitimate interest of a website operator in its effort to continue the operability of its website.

The ECJ’s ruling was based on two questions referred to it by the German Federal Court of Justice (BGH). In the underlying German proceedings, a member of the German Pirate Party challenged the German Federal Government’s logging and subsequent use of his dynamic Internet Protocol (IP) address when visiting their websites. While the government is a public authority, the case was argued on the basis of German provisions that address both public and private website operators, and is therefore directly relevant for commercial companies.

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OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently posted guidance (OCR guidance) clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a covered entity customer to protected health information (PHI) maintained by the vendor on behalf of the customer. Such “information blocking” could occur, for example, during a contract dispute in which a vendor terminates customer access or activates a “kill switch” that renders an information system containing PHI inaccessible to the customer. Many information vendors have historically taken such an approach to commercial disputes.

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Augmented Reality

If you haven’t heard about newest gaming craze yet, it’s based on what is called “augmented reality” (AR) and it could potentially impinge on your home life and workplace as such games allow users to “photograph” imaginary items overlaid with objects existing in the real world. An augmented reality game differs from “virtual reality” in that it mixes elements of the real world with avatars, made up creatures, fanciful landscapes and the like, rather than simply presenting a completely fictional scenario. Whether you play such games yourself or are merely existing in nearby surroundings, here are few things to think about as an active participant, and some tips regarding Intellectual Property and confidentiality issues that arise from others playing the game around you.

Augmented reality games are typically played on a smartphone app and some of them allow the user to capture images of the player’s experience and post it on social media, text it to friends or maintain it on the phone’s camera roll. However, special glasses could be used or other vehicles could deliver the augmented reality experience in different contexts—not just gaming. For example, technology in this area is rapidly advancing which will allow users to link up and “experience” things together way beyond what exists in the real world, i.e., in a “mixed world” experience, if you will. These joint holographic experiences are just one facet of the direction that augmented reality is taking.

As always, with new technological advancements, there are some caveats to using AR that you should be aware of.

Trademarks

If a company’s trademark is visible in the photo of your AR experience, you need to be mindful that you do not run afoul of trademark laws. For the same reasons that some trademarks are blurred out on TV shows, you should not be publishing such photos in any fashion that might draw negative attention from the trademark owner on social media accounts. Even if you are not selling competing goods, you could potentially be liable for trademark infringement. There is another, more important reason not to post such photos that is discussed below and can lead to a second cause of action against you arising from the same photo—the right of publicity, which is a personal right and is treated in vastly different ways in each state.

Right of Publicity

The Right of Publicity (ROP) protects everyone from misappropriation of his/her name, likeness, voice, image or other recognizable element of personal identity. It is protected by state law and many states vary greatly in their treatment of ROP. For example, some states protect a person’s ROP post-mortem, whereas others have no protection whatsoever. Due to the ease with which still or moving images can be reproduced and posted on the Internet, it is critical that you consider your postings from a ROP standpoint before you upload that image to a social media account. For instance, if your photo features your best friend taken in a shared AR experience, she may not object [...]

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Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws.

The HIPAA Security Rule requires covered entities and business associates to implement security measures. It also requires covered entities and business associates to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information (ePHI) the entities create, receive, maintain or transmit and to implement security measures sufficient to reduce those identified risks and vulnerabilities to a reasonable and appropriate level. The HIPAA Security Rule establishes a floor for the security of ePHI, although additional and/or more stringent security measures are certainly permissible and may be required under state law. Compliance with HIPAA’s existing requirements provides covered entities and business associates with guidance on how to prevent and address breaches that compromise protected health information. The new HIPAA guidance specific to ransomware reinforces how the existing requirements can help an entity protect sensitive information.

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Mobile Health Tools, Developers Need Better Data Protection Guidance, Attorney Jennifer Geetter Says

After three government agencies collectively created an online tool to help developers navigate federal regulations impacting mobile health apps, McDermott partner Jennifer Geetter was interviewed by FierceMobileHealthcare on the need for mobile health development tools.

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Farewell ‘Safe Harbor,’ Hello ‘Privacy Shield’: Europe and U.S. Agree on New Rules for Transatlantic Data Transfer

After intense negotiations, and after the official deadline had passed on Sunday, 31 January 2016, the United States and the European Union have finally agreed on a new set of rules—the “EU-U.S. Privacy Shield”—for data transfers across the Atlantic. The Privacy Shield replaces the old Safe Harbor agreement, which was struck down by the European Court of Justice (ECJ) in October 2015. Critics already comment that the Privacy Shield will share Safe Harbor’s fate and will be declared invalid by the ECJ; nevertheless, until such a decision exists, the Privacy Shield should give companies legal security when transferring data to the United States.

While a text of the new agreement is not yet published, European Commissioner Věra Jourvá stated that the Privacy Shield should be in place in the next few weeks. According to a press release from the European Commission, the new arrangement

…will provide stronger obligations on companies in the U.S. to protect the personal data of Europeans and stronger monitoring and enforcement by the U.S. Department of Commerce and Federal Trade Commission (FTC), including through increased cooperation with European Data Protection Authorities. The new arrangement includes commitments by the U.S. that possibilities under U.S. law for public authorities to access personal data transferred under the new arrangement will be subject to clear conditions, limitations and oversight, preventing generalized access. Europeans will have the possibility to raise any enquiry or complaint in this context with a dedicated new Ombudsperson.

One of the most known critics of the U.S. data processing practices and initiator of the ECJ Safe Harbor decision, Austrian Max Schrems, already reacted to the news. Schrems stated on social media that the ECJ Safe Harbor decision explicitly says that “generalized access to content of communications” by intelligence agencies violates the fundamental right to respect for privacy. Commissioner Jourová, referring to the Privacy Shield, stated that “generalized access … may happen in very rare cases”—which could be viewed as contradictory to the ECJ decision. Critics also argue that an informal commitment by the United States during negotiations with the European Union is not something on which European citizens could base lawsuits in the United States if their data is transferred or used illegally.

The European Commission will now prepare a draft text for the Privacy Shield, which still must be ratified by the Member States. The EU Parliament will also review the draft text. In the meantime, the United States will make the necessary preparations to put in place the new framework, monitoring mechanisms and new ombudsperson.

 




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FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016,  the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing postmarket cybersecurity vulnerabilities in medical devices that contain software or programmable logic and software that is a medical device, including networked medical devices. The Draft Guidance represents FDA’s latest attempt to outline principles intended to enhance medical device cybersecurity throughout the product lifecycle.

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