Discerning Data

New FDA Guidance on Waiver of Informed Consent for Minimal Risk Investigations

The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.

The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue. The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.

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Beyond FERPA: Safeguarding Student Data Is Key Obligation for Postsecondary Educational Institutions

Most institutions of higher education are very familiar with the Family Educational Rights Protection Act (FERPA), which applies to all state and local, public and private educational institutions that receive federal funds through programs administered by the U.S. Department of Education (ED). Unless at least one of FERPA’s exceptions applies, institutions risk sanctions from ED – including the potential loss of all federal funding – if they disclose a student’s personally identifiable information (PII) from an education record without the student’s express prior written consent. Beyond FERPA, higher education institutions have additional legal responsibilities to assiduously secure and protect student data from inadvertent disclosure, particularly financial information maintained by an institution regarding students or their families.

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FTC Updates COPPA Guidance to Approve New Parental Consent Methods; Clarify Obligations for Sites not Primarily Targeting Children

The Federal Trade Commission (FTC) has updated its guidance applicable to the Children’s Online Privacy Protection Act (COPPA) to reflect developments in the digital advertising ecosystem and a burgeoning Internet of Things marketplace. The Guidance revises its six-step compliance plan to keep current with developing technology.

The Guidance, which had existed in substantially the same form since 2015, contains three new updates relating to new methods for obtaining parental consent, new products covered by COPPA, and new business models.

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New Jersey Enacts Personal Information and Privacy Protection Act

The New Jersey “Personal Information and Privacy Protection Act” was signed into law on July 21, 2017 by Governor Chris Christie and will be effective November 1, 2017.

The law restricts the way retail establishments may collect and use the personal information contained in the electronic data embedded in identification cards, such as driver’s licenses. The law responds to concerns raised by reports related to how businesses use and store personal information obtained from scanned driver’s licenses.

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New Nevada Law Mandates Posting of Privacy Practices

Nevada recently joined California as the second state to require that operators of websites and online services post public notices outlining their privacy practices. The Nevada law, which went into effect on July 1, requires that the posted notice on the website or online service do the following:

Identify the categories of “covered information” collected through the site.
Describe the process for consumers to review and request changes to the covered information collected through the site.
Describe the process by which the operator notifies consumers of material changes to the notice.
Disclose whether third parties may collect information about a consumer’s online activities over time and across different websites when the consumer uses the site.
List an effective date.

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OCR Responds to Rise in Health Care Cyberattacks

After recent WannaCry ransomware and Petya/notPetya malware attacks exposed the data security vulnerabilities of health care organizations and pharmaceutical companies globally, the Department of Health and Human Services and Office for Civil Rights have rolled out resources to prevent future attacks. The OCR’s resources, such as its Quick-Response Checklist, infographic and informational newsletter, are meant to support health care organizations every step of the way, from planning and contingency plans to response and mitigation procedures.

We’ve outlined some of the key points in the OCR and HHS documents in this recent alert.