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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

HIPAA is the pantheon of healthcare data privacy regulation in the U.S. Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). When does it apply? HTI-1 What is it and when does it apply?

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Improving Access to Medicine: The Role of Pharma Companies in Emerging Markets

PM360

As shareholders and consumers demand greater transparency, accountability, and ethical behavior from corporations, pharmaceutical companies are expected to play a role in addressing these issues. These partnerships can be with local governments, healthcare providers, local startups, and non-governmental organizations.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

2 Having been in place for almost 20 years, the current legislation on blood and on tissues and cells is now outdated and does not reflect the health and societal evolutions These rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.

Safety 66
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How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

When asked how pharma companies could earn more trust from patients, lower drug prices and other financially supported access to treatment ranked as the top things patients would want to see along with more educational resources and support of government policies to protect patients’ rights.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. As these drugs are not licensed for the specific indication of gender-affirming care, collecting safety data on off-label use is not viewed as a priority.

Ethics 144