Category: cybersecurity

Secure Software Regulations and Self-Attestation Required for Federal Contractors

US Policy and Regulatory Alert

Government contractors providing software across the federal government’s supply chain will be required later this year to comply with a new Secure Software Design Framework (SSDF). The SSDF requires software vendors to attest to new security controls in the design of code used by the federal government.

Cybersecurity Compromises of Government Software on the Rise

In the aftermath of the cybersecurity compromises of significant enterprise software systems embedded in government supply chains, the federal government has increasingly prioritized reducing the vulnerability of software used within agency networks. Recognizing that most of the enterprise software that is used by the federal government is provided by a wide range of private sector contractors, the White House has been moving to impose a range of new software security regulations on both prime and subcontractors. One priority area is an effort to require government contractors to ensure that software used by federal agencies incorporates security by design. As a result, federal contractors supplying software to the government now face a new set of requirements to supply secure software code. That is, to provide software that is developed with security in mind so that flaws and vulnerabilities can be mitigated before the government buys and deploys the software.

The SSDF as A Government Response

In response, the White House issued Executive Order 14028, “Executive Order on Improving the Nation’s Cybersecurity” (EO 14028), on 12 May 2021. EO 14028 requires the National Institute of Standards and Technology (NIST) to develop standards, tools, and best practices to enhance the security of the software supply chain. NIST subsequently promulgated the SSDF in special publication NIST SP 800-218. EO 14028 also mandates that the director of the Office of Management and Budget (OMB) take appropriate steps to ensure that federal agencies comply with NIST guidance and standards regarding the SSDF. This resulted in OMB Memorandum M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices” (M-22-18). The OMB memo provides that a federal agency may use software subject to M-22-18’s requirements only if the producer of that software has first attested to compliance with federal government-specified secure software development practices drawn from the SSDF. Meaning, if the producer of the software cannot attest to meeting the NIST requirements, it will not be able to supply software to the federal government. There are some exceptions and processes for software to gradually enter into compliance under various milestones for improvements, all of which are highly technical and subjective.

In accordance with these regulations, the Cybersecurity and Infrastructure Security Agency (CISA) of the Department of Homeland Security issued a draft form for collecting the relevant attestations and associated information. CISA released the draft form on 27 April 2023 and is accepting comments until 26 June 2023.1

SSDF Implementation Deadline and Requirements for Government Suppliers

CISA initially set a deadline of 11 June 2023 for critical software and 13 September 2023 for non-critical software to comply with SSDF. Press reports indicate that these deadlines will be extended due to both the complexity of the SSDF requirements and the fact that the comment period remains open until 26 June  2023. However, CISA has not yet confirmed an extension of the deadline.

Attestation and Compliance with the SSDF

Based on what we know now, the attestation form generally requires software producers to confirm that:

  • The software was developed and built in secure environments.
  • The software producer has made a good-faith effort to maintain trusted source code supply chains.
  • The software producer maintains provenance data for internal and third-party code incorporated into the software.
  • The software producer employed automated tools or comparable processes that check for security vulnerabilities.

Software producers that must comply with SSDF should move quickly and begin reviewing their approach to software security. The SSDF requirements are complex and likely will take time to review, implement, and document. In particular, many of the requirements call for subjective analysis rather than objective evaluation against a set of quantifiable criteria, as is usually the case with such regulations. The SSDF also includes numerous ambiguities. For example, the SSDF requires versioning changes in software to have certain impacts in the security assessment, although the term “versioning” does not have a standard definition in the software sector.

Next Steps and Ricks of Noncompliance

Critically, the attestations on the new form carry risk under the civil False Claims Act for government contractors and subcontractors. Given the fact that many of the attestations require subjective analysis, contractors must take exceptional care in completing the attestation form. Contractors should carefully document their assessment that the software they produce is compliant. In particular, contractors and other interested parties should use this opportunity to share feedback and insights with CISA through the public comment process.

K&L Gates lawyers in our National Security Practice are closely tracking the implementation of these new requirements.

1 88 Fed. Reg. 25,670.

Copyright 2023 K & L Gates

Software as a Medical Device: Challenges Facing the Industry

SaMD Blog Series: Introduction

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical devices. We will be addressing various considerations including technology, data, intellectual property, licensing, and contracting.

The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, SaMD need not be part of a physical device to achieve its intended purpose. For instance, SaMD could be an application on a mobile phone and not be connected to a physical medical device.

With the proliferation of SaMD also comes the need for those building and using it to firmly grasp legal and regulatory considerations to ensure successful use and commercialization. Over the next several weeks, we will be addressing some of more common issues faced by digital health companies, investors, innovators, and clinicians when developing, utilizing, or commercializing SaMD. The Food and Drug Administration (FDA) has already cleared a significant amount of SaMD, including more than 500 algorithms employing artificial intelligence (AI). Some notable examples include FDA-cleared SaMD such as wearable technology for remote patient monitoring; doctor prescribed video game treatment for children with ADHD; fully immersive virtual reality tools for both physical therapy and mental wellness; and end to end software that generates 3D printed models to better plan surgery and reduce operation time. With this rapid innovation comes a host of legal and regulatory considerations which will be discussed over the course of this SaMD Blog Series.

General Intellectual Property (IP) Considerations for SaMD

This edition will discuss the sophisticated IP strategies that can be used to protect innovations for the three categories of software for biomedical applications: SaMD, software in a medical device, and software used in the manufacture or maintenance of a medical device, including clinical trial collaboration and sponsored research agreements, filing patent applications, and pursuing other forms of protection, such as trade secrets.

Licensing and Contracting with Third Parties for SaMD

This edition will unpack engaging with third parties practically and comprehensively, whether in the context of (i) developing new SaMD or (ii) refining or testing existing SaMD. Data and IP can be effectively either owned or licensed, provided such licenses protect the future interests of the licensee. Such ownership and licensing are particularly important in the AI and machine learning space, which is one area of focus for this edition.

FDA Considerations for SaMD

This edition will explore how FDA is regulating SaMD, which will include a discussion of what constitutes a regulated device, legislative actions to spur innovation, and how FDA is approaching regulation of specific categories of SaMD such as clinical decision support software, general wellness applications, and other mobile medical devices. It will also examine the different regulatory pathways for SaMD and FDA’s current focus on Cybersecurity issues for software.

Health Care Regulatory and Reimbursement Considerations for SAMD

This edition will discuss the intersection of remote monitoring services and SaMD, prescription digital therapeutics and how they intersect with SaMD, licensure and distributor considerations associated with commercializing SaMD, and the growing trend to seek out device specific codes for SaMD.

Our hope is that this series will be a starting point for digital health companies, investors, innovators, and clinicians as each approaches development and use of SaMD as part of their business and clinical offerings.

© 2023 Foley & Lardner LLP

For more information on Healthcare, click here to visit the National Law Review.

 

Clop Claims Zero-Day Attacks Against 130 Organizations

Russia-linked ransomware gang Clop has claimed that it has attacked over 130 organizations since late January, using a zero-day vulnerability in the GoAnywhere MFT secure file transfer tool, and was successful in stealing data from those organizations. The vulnerability is CVE-2023-0669, which allows attackers to execute remote code execution.

The manufacturer of GoAnywhere MFT notified customers of the vulnerability on February 1, 2023, and issued a patch for the vulnerability on February 7, 2023.

HC3 issued an alert on February 22, 2023, warning the health care sector about Clop targeting healthcare organizations and recommended:

  • Educate and train staff to reduce the risk of social engineering attacks via email and network access.
  • Assess enterprise risk against all potential vulnerabilities and prioritize implementing the security plan with the necessary budget, staff, and tools.
  • Develop a cybersecurity roadmap that everyone in the healthcare organization understands.

Security professionals are recommending that information technology professionals update machines to the latest GoAnywhere version and “stop exposing port 8000 (the internet location of the GoAnywhere MFT admin panel).”

Article By Linn F. Freedman of Robinson & Cole LLP

For more cybersecurity legal news, click here to visit the National Law Review.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

Privacy Tip #358 – Bank Failures Give Hackers New Strategy for Attacks

Hackers are always looking for the next opportunity to launch attacks against unsuspecting victims. According to Cybersecurity Dive, researchers at Proofpoint recently observed “a phishing campaign designed to exploit the banking crisis with messages impersonating several cryptocurrencies.”

According to Cybersecurity Dive, cybersecurity firm Arctic Wolf has observed “an uptick in newly registered domains related to SVB since federal regulators took over the bank’s deposits…” and “expects some of those domains to serve as a hub for phishing attacks.”

This is the modus operandi of hackers. They use times of crises, when victims are vulnerable, to launch attacks. Phishing campaigns continue to be one of the top risks to organizations, and following the recent bank failures, everyone should be extra vigilant of urgent financial requests and emails spoofing financial institutions, and take additional measures, through multiple levels of authorization, when conducting financial transactions.

We anticipate increased activity following these recent financial failures attacking individuals and organizations. Communicating the increased risk to employees may be worth consideration.

Article By Linn F. Freedman of Robinson & Cole LLP

For more communications, media, and internet legal news, click here to visit the National Law Review.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

Locking Tik Tok? White House Requires Removal of TikTok App from Federal IT

On February 28, the White House issued a memorandum giving federal employees 30 days to remove the TikTok application from any government devices. This memo is the result of an act passed by Congress that requires the removal of TikTok from any federal information technology. The act responded to concerns that the Chinese government may use data from TikTok for intelligence gathering on Americans.

I’m Not a Federal Employee — Why Does It Matter?

The White House Memo clearly covers all employees of federal agencies. However, it also covers any information technology used by a contractor who is using federal information technology.  As such, if you are a federal contractor using some sort of computer software or technology that is required by the U.S. government, you must remove TikTok in the next 30 days.

The limited exceptions to the removal mandate require federal government approval. The memo mentions national security interests and activities, law enforcement work, and security research as possible exceptions. However, there is a process to apply for an exception – it is not automatic.

Takeaways

Even if you are not a federal employee or a government contractor, this memo would be a good starting place to look back at your company’s social media policies and cell phone use procedures. Do you want TikTok (or any other social media app) on your devices? Many companies have found themselves in PR trouble due to lapses in enforcement of these types of rules. In addition, excessive use of social media in the workplace has been shown to be a drag on productivity.

Article By J. William Manuel and Anne R. Yuengert of Bradley Arant Boult Cummings LLP

For more communications, media, and internet legal news, click here to visit the National Law Review.

© 2023 Bradley Arant Boult Cummings LLP

Privacy Tip #359 – GoodRx Settles with FTC for Sharing Health Information for Advertising

The Federal Trade Commission (FTC) announced on February 1, 2023 that it has settled, for $1.5M, its first enforcement action under its Health Breach Notification Rule against GoodRx Holdings, Inc., a telehealth and prescription drug provider.

According to the press release, the FTC alleged that GoodRx failed “to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google, and other companies.”

In the proposed federal court order (the Order), GoodRx will be “prohibited from sharing user health data with applicable third parties for advertising purposes.” The complaint alleged that GoodRx told consumers that it would not share personal health information, and it monetized users’ personal health information by sharing consumers’ information with third parties such as Facebook and Instagram to help target users with ads for personalized health and medication-specific ads.

The complaint also alleged that GoodRx “compiled lists of its users who had purchased particular medications such as those used to treat heart disease and blood pressure, and uploaded their email addresses, phone numbers, and mobile advertising IDs to Facebook so it could identify their profiles. GoodRx then used that information to target these users with health-related advertisements.” It also alleges that those third parties then used the information received from GoodRx for their own internal purposes to improve the effectiveness of the advertising.

The proposed Order must be approved by a federal court before it can take effect. To address the FTC’s allegations, the Order prohibits the sharing of health data for ads; requires user consent for any other sharing; stipulates that the company must direct third parties to delete consumer health data; limits the retention of data; and implement a mandated privacy program. Click here to read the press release.

Article By Linn F. Freedman of Robinson & Cole LLP

For more privacy and cybersecurity legal news, click here to visit the National Law Review.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

NIST Releases New Framework for Managing AI and Promoting Trustworthy and Responsible Use and Development

On January 26, 2023, the National Institute of Standards and Technology (“NIST”) released the Artificial Intelligence Risk Management Framework (“AI RMF 1.0”), which provides a set of guidelines for organizations that design, develop, deploy or use AI to manage its many risks and promote trustworthy and responsible use and development of AI systems.

The AI RMF 1.0 provides guidance as to how organizations may evaluate AI risks (e.g., intellectual property, bias, privacy and cybersecurity) and trustworthiness. The AI RMF 1.0 outlines the characteristics of trustworthy AI systems, which are valid, reliable, safe, secure, resilient, accountable, transparent, explainable, interpretable, privacy enhanced and fair with their harmful biases managed. It also describes four high-level functions, with associated actions and outcomes to help organizations better understand and manage AI:

  • The Govern function addresses evaluation of AI technologies’ policies, processes and procedures, including their compliance with legal and regulatory requirements and transparent and trustworthy implementation.
  • The Map function provides context for organizations to frame risks relating to AI systems, including AI system impacts and interdependencies.
  • The Measure function uses quantitative, qualitative or mixed-method tools, techniques and methodologies to analyze, benchmark and monitor AI risk and related impacts, including tracking metrics to determine trustworthy characteristics, social impact and human-AI configurations.
  • The Manage function entails allocating risk resources to mapped and measured risks consistent with the Govern function. The Manage function includes determining how to treat risks and develop plans to respond to, recover from and communicate about incidents and events.

NIST released a draft AI Risk Management Framework Playbook to accompany the AI RMF 1.0. NIST plans to release an updated version of the Playbook in the Spring of 2023 and launch a new Trustworthy and Responsible AI Resource Center to help organizations put AI RMF 1.0 into practice. NIST has also provided a Roadmap of its priorities to advance the AI RMF.

Copyright © 2023, Hunton Andrews Kurth LLP. All Rights Reserved.
For more Technology Legal News, click here to visit the National Law Review.

University of Texas at Austin Permanently Blocks TikTok on Network

On Tuesday, January 17, 2023, the University of Texas at Austin announced that it has blocked TikTok access across the university’s networks. According to the announcement to its users, “You are no longer able to access TikTok on any device if you are connected to the university via its wired or WIFI networks.” The measure was in response to Governor Greg Abbott’s December 7, 2022, directive to all state agencies to eliminate TikTok from state networks. Following the directive, the University removed TikTok from university-issued devices, including cell phones, laptops and work stations.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

For  more Cybersecurity Legal News, click here to visit the National Law Review.

Another Lesson for Higher Education Institutions about the Importance of Cybersecurity Investment

Key Takeaway

A Massachusetts class action claim underscores that institutions of higher education will continue to be targets for cybercriminals – and class action plaintiffs know it.

Background

On January 4, 2023, in Jackson v. Suffolk University, No. 23-cv-10019, Jackson (Plaintiff) filed a proposed class action lawsuit in the U.S. District Court for the District of Massachusetts against her alma matter, Suffolk University (Suffolk), arising from a data breach affecting thousands of current and former Suffolk students.

The complaint alleges that an unauthorized party gained access to Suffolk’s computer network on or about July 9, 2022.  After learning of the unauthorized access, Suffolk engaged cybersecurity experts to assist in an investigation. Suffolk completed the investigation on November 14, 2022.  The investigation concluded that an unauthorized third party gained access to and/or exfiltrated files containing personally identifiable information (PII) for students who enrolled after 2002.

The complaint further alleges that the PII exposed in the data breach included students’ full names, Social Security Numbers, Driver License numbers, state identification numbers, financial account information, and Protected Health Information.  While Suffolk did not release the total number of students affected by the data breach, the complaint alleges that approximately 36,000 Massachusetts residents were affected.  No information was provided about affected out-of-state residents.

Colleges and Universities are Prime Targets for Cybercriminals

Unfortunately, Suffolk’s data breach is not an outlier.  Colleges and universities present a wealth of opportunities for cyber criminals because they house massive amounts of sensitive data, including employee and student personal and financial information, medical records, and confidential and proprietary data.  Given how stolen data can be sold through open and anonymous forums on the Dark Web, colleges and universities will continue to remain prime targets for cybercriminals.

Recognizing this, the FBI issued a warning for higher education institutions in March 2021, informing them that cybercriminals have been targeting institutions of higher education with ransomware attacks.  In May 2022, the FBI issued a second alert, warning that cyber bad actors continue to conduct attacks against colleges and universities.

Suffolk Allegedly Breached Data Protection Duty

In the complaint, Plaintiff alleges that Suffolk did not follow industry and government guidelines to protect student PII.  In particular, Plaintiff alleges that Suffolk’s failure to protect student PII is prohibited by the Federal Trade Commission Act, 15 U.S.C.A. § 45 and that Suffolk failed to comply with the Financial Privacy Rule of the Gramm-Leach-Bliley Act (GLBA),  15 U.S.C.A. § 6801.  Further, the suit alleges that Suffolk violated the Massachusetts Right to Privacy Law, Mass. Gen. Laws Ann. ch. 214, § 1B, as well as its common law duties.

How Much Cybersecurity is Enough?

To mitigate cyber risk, colleges and university must not only follow applicable government guidelines but also  consider following industry best practices to protect student PII.

In particular, GLBA requires a covered organization to designate a qualified individual to oversee its information security program and conduct risk assessments that continually assess internal and external risks to the security, confidentiality and integrity of personal information.  After the risk assessment, the organization must address the identified risks and document the specific safeguards intended to address those risks.  See 16 CFR § 314.4.  

Suffolk, as well as other colleges and universities, may also want to look to Massachusetts law for guidance about how to further invest in its cybersecurity program.  Massachusetts was an early leader among U.S. states when, in 2007, it enacted the “Regulations to safeguard personal information of commonwealth residents” (Mass. Gen. Laws ch. 93H § 2) (Data Security Law).  The Data Security Law – still among the most prescriptive general data security state law – sets forth a list of minimum requirements that, while not specific to colleges and universities, serves as a good cybersecurity checklist for all organizations:

  1. Designation of one or more employees responsible for the WISP.
  2. Assessments of risks to the security, confidentiality and/or integrity of organizational Information and the effectiveness of the current safeguards for limiting those risks, including ongoing employee and independent contractor training, compliance with the WISP and tools for detecting and preventing security system failures.
  3. Employee security policies relating to protection of organizational Information outside of business premises.
  4. Disciplinary measures for violations of the WISP and related policies.
  5. Access control measures that prevent terminated employees from accessing organizational Information.
  6. Management of service providers that access organizational Information as part of providing services directly to the organization, including retaining service providers capable of protecting organizational Information consistent with the Data Security Regulations and other applicable laws and requiring service providers by contract to implement and maintain appropriate measures to protect organizational Information.
  7. Physical access restrictions for records containing organizational Information and storage of those records in locked facilities, storage areas or containers.
  8. Regular monitoring of the WISP to ensure that it is preventing unauthorized access to or use of organizational Information and upgrading the WISP as necessary to limit risks.
  9. Review the WISP at least annually or more often if business practices that relate to the protection of organizational Information materially change.
  10. Documentation of responsive actions taken in connection with any “breach of security” and mandatory post-incident review of those actions to evaluate the need for changes to business practices relating to protection of organizational Information.

An organization not implementing any of these controls should consider documenting the decision-making process as a defensive measure.  In implementing these requirements and recommendations, colleges and universities can best position themselves to thwart cybercriminals and plaintiffs alike.

Article By Ericka A. Johnson and Julia B. Jacobson of Squire Patton Boggs (US) LLP

For more cybersecurity and data privacy legal news, click here to visit the National Law Review.

© Copyright 2023 Squire Patton Boggs (US) LLP

Ankura CTIX FLASH Update – January 3, 2023

Malware Activity

Louisiana’s Largest Medical Complex Discloses Data Breach Associated to October Attack

On December 23rd, 2022, the Lake Charles Memorial Health System (LCMHS) began sending out notifications regarding a newly discovered data breach that is currently impacting approximately 270,000 patients. LCMHS is the largest medical complex in Lake Charles, Louisiana, which contains multiple hospitals and a primary care clinic. The organization discovered unusual activity on their network on October 21, 2022, and determined on October 25, 2022, that an unauthorized actor gained access to the organization’s network as well as “accessed or obtained certain files from [their] systems.” The LCMHS notice listed the following patient information as exposed: patient names, addresses, dates of birth, medical record or patient identification numbers, health insurance information, payment information, limited clinical information regarding received care, and Social Security numbers (SSNs) in limited instances. While LCMHS has yet to confirm the unauthorized actor responsible for the data breach, the Hive ransomware group listed the organization on their data leak site on November 15, 2022, as well as posted files allegedly exfiltrated after breaching the LCMHS network. The posted files contained “bills of materials, cards, contracts, medical info, papers, medical records, scans, residents, and more.” It is not unusual for Hive to claim responsibility for the associated attack as the threat group has previously targeted hospitals/healthcare organizations. CTIX analysts will continue to monitor the Hive ransomware group into 2023 and provide updates on the Lake Charles Memorial Health System data breach as necessary.

Threat Actor Activity

Kimsuky Threat Actors Target South Korean Policy Experts in New Campaign

Threat actors from the North Korean-backed Kimsuky group recently launched a phishing campaign targeting policy experts throughout South Korea. Kimsuky is a well-aged threat organization that has been in operation since 2013, primarily conducting cyber espionage and occasional financially motivated attacks. Aiming their attacks consistently at entities of South Korea, the group often targets academics, think tanks, and organizations relating to inter-Korea relations. In this recent campaign, Kimsuky threat actors distributed spear-phishing emails to several well-known South Korean policy experts. Within these emails, either an embedded website URL or an attachment was present, both executing malicious code to download malware to the compromised machine. One (1) tactic the threat actors utilized was distributing emails through hacked servers, masking the origin IP address(es). In total, of the 300 hacked servers, eighty-seven (87) of them were located throughout North Korea, with the others from around the globe. This type of social engineering attack is not new for the threat group as similar instances have occurred over the past decade. In January 2022, Kimsuky actors mimicked activities of researchers and think tanks in order to harvest intelligence from associated sources. CTIX continues to urge users to validate the integrity of email correspondence prior to visiting any embedded emails or downloading any attachments to lessen the risk of threat actor compromise.

Vulnerabilities

Netgear Patches Critical Vulnerability Leading to Arbitrary Code Execution

Network device manufacturer Netgear has just patched a high-severity vulnerability impacting multiple WiFi router models. The flaw, tracked as CVE-2022-48196, is described as a pre-authentication buffer overflow security vulnerability, which, if exploited, could allow threat actors to carry out a number of malicious activities. These activities include stealing sensitive information, creating Denial-of-Service (DoS) conditions, as well as downloading malware and executing arbitrary code. In past attacks, threat actors have utilized this type of vulnerability as an initial access vector by which they pivot to other parts of the network. Currently, there is very little technical information regarding the vulnerability and Netgear is temporarily withholding the details to allow as many of their users to update their vulnerable devices to the latest secure firmware. Netgear stated that this is a very low-complexity attack, meaning that unsophisticated attackers may be able to successfully exploit a device. CTIX analysts urge Netgear users with any of the vulnerable devices listed in Netgear’s advisory to patch their device immediately.

For more cybersecurity news, click here to visit the National Law Review.

Copyright © 2023 Ankura Consulting Group, LLC. All rights reserved.