Tag Archives: Consent

FCC Clarifies that COVID-19 “Emergency Purposes” Calls/Text are Not Subject to “Prior Express Consent” Requirement

On March 20, the Federal Communications Commission (“FCC”) on its own motion released a Declaratory Ruling to confirm that the COVID-19 pandemic constitutes an “emergency” under the Telephone Consumer Protection Act (“TCPA”); as a consequence, hospitals, health care providers, state and local health officials, and other government officials may lawfully communicate through automated or prerecorded … Continue Reading

Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government published a draft regulation setting … Continue Reading

CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data

On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data.  The Guideline takes effect on 28 February 2018. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) … Continue Reading

UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions

The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research). The consultation comes after two parallel-track reviews of information governance and data security arrangements in the … Continue Reading
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