News at a Glance – August 2016

FDA Schedules NGS Workshop.The U.S. Food and Drug Administration (FDA) announced it will hold a public workshop Sept. 23 to solicit feedback on the two guidance documents it released in July 2016 addressing next-generation sequencing (NGS)-based in vitro diagnostics and the variant databases that support the clinical validity of such tests. The workshop will include presentations and moderated panel discussions addressing the guidance documents and questions posed in the related Federal Register notices. Stakeholders can attend in person or via webcast. Written or electronic comments related to the workshop can also be submitted by Oct. 6, 2016. See "FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight," G2 Compliance Advisor, July 2016, p. 9 for more in-depth discussion of the guidance documents.

House Committee Studies CDC Laboratory Response Network.The U.S. House of Representatives Energy and Commerce Committee recently requested that the Centers for Disease Control and Prevention (CDC) provide information to the Committee about the capabilities of the CDC's Laboratory Response Network. Committee members emphasized the network's responsibility for ensuring the U.S. has the technology and resources to "test suspicious materials" and promptly detect and respond to potential incidents of bioterrorism or other public health emergencies. Specifically, the committee wants to know how many labs in the U.S. can participate in such activities and the extent of their capabilities. The committee also asked about the number and type of assays that have been developed to facilitate response to such public health emergencies and the network's ability to detect "emerging infectious diseases" such as Zika and Ebola.

HIPAA Turns 20!It's a milestone birthday for a law that is not generally celebrated among health care providers. The Health Insurance Portability and Accountability Act of 1996, better known as HIPAA, was enacted this month 20 years ago on Aug. 21, 1996. The law is perhaps best known for its imposition of privacy and security requirements intended to protect confidentiality of patients' health information. But another key objective of the law when enacted was to allow people to continue health care insurance even after losing a job and to prevent preexisting medical conditions from causing insureds to lose or have difficulty obtaining insurance. The U.S. Department of Health & Human Services issued a statement celebrating the occasion, lauding the legislation for also moving health care into the modern electronic age: "HIPAA simplified and encouraged the electronic transfer of information … and now 93.8% of all health care claims transactions today are conducted in standard form. The HIPAA standards have helped pave the way for interoperability of health data to enhance the patient and provider experience."

HIPAA's privacy and security rules also imposed standards identifying permissible and prohibited uses of patient information and required implementation of physical, technical and administrative safeguards to protect such information from improper disclosure. Modifications to the law have imposed requirements for dealing with and notifying affected patients about breaches of unsecured health information. HHS reports that since the law's requirements went into effect, the Office for Civil Rights (OCR), the agency charged with enforcing the law, has received 137,770 complaints under HIPAA—96% of which were resolved—and OCR has collected a total of $39,989,200 in settlements.