The rise of “precision medicine”, the personalization of medical treatments based on large volumes of health data, has led to the increased use of automation. Advancements in data analytics and automated decision-making (ADM) technologies, which analyse vast genomic datasets to pinpoint personalised treatment strategies, have been game changers in the clinical trials space. Courts [...]
Unlocking the Key to Compliance: Data Privacy Health Checks for Healthcare Organisations Healthcare companies are some of the biggest targets of cyber-attacks, with health data being a particularly sensitive form of personal data. Healthcare organisations store, maintain and transmit vast amounts of data to support the delivery of efficient and appropriate patient care. [...]
Background: The Lei Geral de Proteção de Dados (LGPD) is the Brazilian legal framework that regulates data processing carried out in Brazil and in other countries where the processing operations (i) aim to offer or supply goods and services to people located in Brazil; (ii) process the personal data of people located in Brazil; [...]
Trans-Atlantic Transfers of Health Data Since the Covid 19 Pandemic, clinical trials have become more popular across the globe. A potential stumbling block for organisations sponsoring or engaging in clinical trials is trans-Atlantic transfers of health data. Background Prior to the Schrems II ruling in 2020, a mechanism to permit the transfer of data [...]
Start preparing your business for the EU Framework on artificial intelligence The EU Framework on artificial intelligence (AI), consisting of a regulation establishing harmonised rules on AI (the AI act), and a directive adopting non-contractual civil liability rules to AI (the AI Liability Directive) is expected to be adopted in 2024 or 2025. It [...]
We caught up with Senior Health Care Supervisors in Ghana, in conjunction with the Data Protection Commission-Ghana to discuss the current situation on the enforcement mechanisms for regulating personal data within the Health Sector. Every data-driven organisation should have a privacy framework in place. If your organisation hasn’t yet taken the time to orient [...]
At one time or another, any organisation with operations in Europe will have had to navigate the GDPR: the European data protection law which sets some of the highest standards for data privacy worldwide. For clinical trial sponsors, there's also the European Clinical Trials Regulation ('CTR') to contend with—alongside international laws governing the life [...]
Organisations involved in clinical trials in European Union (EU) Member States, or the UK should consider whether they need to register with data protection regulators. Before the General Data Protection Regulation (GDPR) entered into force in May 2018, the data protection laws in the EU (which at the time included the UK) required organisations [...]
After the hiatus brought about by the pandemic, activity in the clinical trials sector is now growing, with a number of trials due to launch at the end of this quarter. Increasingly, participants in trials and partners in Clinical Research Organisations (CROs) are seeking assurance that a Data Protection Officer (DPO) has been appointed [...]
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