article thumbnail

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?

article thumbnail

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

Nixon Gwilt Law

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). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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. When this is done, appropriate transplant supply needs can be met and adequate funding for tissue, cell and organ donation schemes can be identified.

Ethics 95
article thumbnail

Research integrity: five tips for authors, editors and reviewers

Clarivate

If the research is used to inform policy decisions around, food safety and public health, for example, then misleading and false research can risk people’s lives. Ethical publishing: an introductory course. Share your knowledge around research ethics with your peers, for example by presenting a seminar at your institution.

Ethics 105
article thumbnail

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.

article thumbnail

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?

article thumbnail

Challenges in the Medical Sales Industry

MedReps

First, they’ll likely have more interest in learning about what you sell and second, they’ll be more hesitant to try it because of concerns about insurance coverage, efficacy and safety. Thanks to the mistakes of other companies, the landscape of rules and laws that govern how medical sales reps sell are constantly changing.