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 calls (which include text messages) information about the coronavirus and mitigation measures to mobile telephone numbers and certain other numbers (such as those of first responders) without “prior express consent.”
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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…
CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data
By Daniel Pavin & Raj Gathani on
Posted in Genomics, Health 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”) developed the Guideline in acknowledgement of the growing awareness of, and interest in, genomic data generated from clinical studies. The ICH suggested that the absence of a harmonized guideline made it more difficult to conduct genomic research consistently in global studies. The fact that the CHMP has adopted the Guideline means that EU guidance on this subject is now aligned with the ICH standard.
The Guideline provides general principles for the collection and handling of genomic samples and management of genomic data. It also affirms broader principles, such as the need for informed consent and the protection of subjects’ privacy etc. The Guideline applies to both interventional and non-interventional clinical studies, irrespective of when the genomic research is carried out and whether it was envisaged in the study protocol. The ICH/CHMP intend the Guideline to be interpreted in accordance with the law and policies in each jurisdiction where genomic research takes place.
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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 NHS found a number of shortcomings, described below. The Care Quality Commission (CQC) and the National Data Guardian (NDG, led by Dame Fiona Caldicott) made a range of recommendations, including new security standards, stronger inspection and enforcement around security lapses and re-identification of anonymized patient data, and an eight-point process around assuming and respecting patient consent decisions.
Following the public consultation, the new security standards could eventually be required and audited by government inspectors from the CQC, and imposed under revised standard NHS England contract terms. CQC inspectors could potentially act on tip-offs from NHS Digital (formerly known as the NHS Health and Social Care Information Centre, ‘HSCIC’). Those tip-offs could be based on low scores obtained by organizations in their annual NHS Information Governance Toolkit (IGT) self-assessments. The IGT, which the reviewers said should be redesigned, applies both to NHS bodies and their commercial vendors.
The new consent model, meanwhile, could provide more streamlined, system-wide consents for use of patient data for purposes including quality assurance and research.
The CQC and the NDG’s findings and twenty-four recommendations were jointly presented in a covering letter to the UK government, available here, and fuller reports, available here and here (CQC and NDG, respectively). This post provides a brief summary of their main findings and recommendations. For the consultation questions themselves, see here.
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