Remove the American Privacy Rights Act
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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Given the public health emergency, health authorities offered greater flexibilities in the use of digital health platforms and technologies such as: Enhanced HIPAA (Health Insurance Portability and Accountability Act of 1996) flexibilities in the use of telemedicine services 3. James Wabby. 1 November 2022. What Is Digital Health?

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The Road to Explainable AI in GXP-Regulated Areas

ISPE

However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain. 1 AI developments offer a solution: Explainable AI (xAI): i.e., additional modules on top of the AI core solution that are designed to explain the results to a human audience. 1 Samek, W.,

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Understanding the current and future state of complex health data protection laws

Pharmaceutical Technology

In April 2023, Washington State Senate passed the My Health, My Data Act designed to protect the “independence and dignity of individuals when making healthcare decisions.” The Act comes as consumers demand more rights to access, delete, or withdraw consent of their PHI, along with clearer guidelines as to how such data can be used.

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Consent and Preference Management 

Pharmaceutical Technology

Mismanagement and misuse of such confidential data assets may tarnish the trust of people in them and may also bring litigation. The needs of healthcare personnel (HCPs) and patients have evolved over the years with the increasing use of digital technologies, such as apps and virtual chat tools, and the adoption of personalised medicine.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

But experts say it’s about “right shoring” – having parts of the supply chain and processes in the strategic location rather than the entire operation; thus delivering the desirable combination of cost, efficiency, and reliability of supply. The challenges of ‘right shoring’ Governments in Europe and the UK are incentivising supply reshoring.

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Primate models in pharma: What the future holds

Pharmaceutical Technology

The Animals (Scientific Procedures) Act 1986 (ASPA) stipulates that animals, including non-human primates, are only used in research when other methods are not sufficient to obtain the necessary information. This was part of an investigation into an international primate smuggling ring. In 2021, they accounted for 0.2%

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AstraZeneca ends Phase IV Andexxa trial after positive results

Pharmaceutical Technology

The drug works by acting as a decoy for FXa inhibitors, anticoagulants, that would usually bind to the FXa molecule to produce the anticoagulant effect. AstraZeneca has announced it would stop Andexxa’s Phase IV trial after the study achieved its aims earlier than expected. The treatment had been granted accelerated approval in the US.

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