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

Nixon Gwilt Law

That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. HIPAA is the pantheon of healthcare data privacy regulation in the U.S. HIPAA What is it?

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Life science companies are increasingly using advanced technologies like artificial intelligence (AI), machine learning (ML) and blockchain to improve data quality and integrity by detecting anomalies in data and establishing tamper-proof audit trails for all data-related activities Data governance. How can this be mitigated?

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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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Sharing data on human tissue availability across EU

European Pharmaceutical Review

Sharing data across borders ensures access to safe tissues and cells for human application is ethical and supply quality is adequate, said the Council in a statement. Improving communication between public health authorities was also a key aim.

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

As new healthcare challenges arise and the pharmaceutical landscape evolves, the FDA may be allocating its resources to focus on other pressing issues, such as drug approvals, monitoring emerging health threats, and enhancing drug safety. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

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Clinical trials and pregnancy: regulators weigh in

Clarivate

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Margolis Center for Health Policy to convene a February 2021 public meeting about scientific and ethical issues associated with enrolling pregnant individuals in clinical trials for drug development.

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How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. Be clear in your governance documents and training to level set expectations. For example, everyone must be steeped in both FDA and FTC guidelines. Rishi Kadiwar.