Pharmaceutical Company to Plead Guilty and Settle Drug Marketing Charges

Hunton Privacy

Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid.

Making Internal Audits More Relevant

Data Breach Today

Prasanna Bharatan, internal auditor at the pharmaceutical company Wockhardt, outlines the important steps to take Wockhardt's Prasanna Bharatan on Why Audits Often Are Not Meaningful How can improve internal audits be improved and made more meaningful?

ISO identification of medicinal products (IDMP)

OpenText Information Management

Enterprise Content Management Information Management EIM ISO IDMP Life sciences pharmaceuticalIn a previous blog I looked at some of the EU regulations that are disrupting the Life Sciences sector.

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Introducing OpenText Life Sciences Express – it’s simple

OpenText Information Management

Simplicity. That’s what every Life Sciences professional working with regulated business processes needs today. That’s exactly what they’re getting with the intuitive user experience and efficient cloud-based access of our new OpenText™ Life Sciences Express. Here’s why simplicity is so important.

The hidden threats facing your intellectual property

IT Governance

For life sciences and pharmaceutical companies, this includes data on the development and testing of new therapies and details of how therapies are manufactured. Cyber Resilience Healthcare Intellectual Property Life Sciences Pharmaceutical

Former Physician Convicted of Criminal HIPAA Violation

Data Breach Today

The case was tied to providing a pharmaceutical salesperson access to patients' medical records Case Involved Unauthorized Access to Patient Records A former Massachusetts gynecologist has been convicted in a rare case involving a criminal HIPAA violation.

My Health Record 'identical' to failed UK scheme, privacy expert says

The Guardian Data Protection

Health Data protection Australia news Technology Privacy Pharmaceuticals industryCare.data was cancelled because drug and insurance companies were able to buy patient data Australia’s impending My Health Record system is “identical” to a failed system in England that was cancelled after it was found to be selling patient data to drug and insurance companies , a British privacy expert has said.

Maintaining Regulatory-Compliant Cloud Solutions

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology

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Who Is Responsible For The Compliance Of Cloud Systems?

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyAny time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor.

Refresher: Which IT Systems Are Regulated

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIf your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated.

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Key Takeaways About Compliant IT Systems In The Cloud

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyThis is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way!

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How To Qualify Cloud Vendors

Perficient Data & Analytics

Because the ultimate responsibility for regulatory compliance lies with you – the pharmaceutical or medical device company – you need to be much more proactive and critical. Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology

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How To Use Contracts For Regulatory Compliance Of Cloud Systems

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIn the previous post in this series, we discussed how to qualify cloud vendors.

Using a 'Privacy by Design' Approach to GDPR Compliance

Data Breach Today

To prepare for compliance with the EU's GDPR, which will be enforced beginning in May, organizations must adopt a "privacy by design" approach, says Subhajit Deb, CISO at Dr. Reddy's Laboratories, an India headquartered pharmaceutical company that does business in 11 countries

Introducing Box GxP Validation: Compliance for an Agile Cloud

Box

Organizations in the life sciences, including pharmaceuticals, biotech and medical device companies, are rapidly transforming.

Implementing a real-time catalog of enterprise data assets

Information Management Resources

Beyond defining access privileges, effective data governance means that companies need to be able to document or label their data assets, much like the labels on pharmaceuticals. Data management Data visualization Data discovery

My Health Record: big pharma can apply to access data

The Guardian Data Protection

‘Each application would be assessed on its own merits,’ senators told Pharmaceutical companies will be allowed to apply for data from the controversial My Health Record system, a Senate committee hearing has been told. Caroline Edwards, the deputy secretary of the Department of Health, told the committee third-party access arrangements would allow medical and public health researchers access to de-identified data. Continue reading.

Regulatory Matters: EU regulatory change is coming fast in Life Sciences

OpenText Information Management

However, the next few years are about to see major new legislation in the EU that could result in major disruption to Life Sciences, Pharmaceutical and Healthcare companies – wherever they are. The Life Sciences sector is used to constant regulatory change.

This is the old ChiefTech blog.: Janssen-Cilag Wiki Case Study

ChiefTech

Tuesday, 21 August 2007 Janssen-Cilag Wiki Case Study Here is a great Aussie wiki case study shared by Nathan Wallace from Janssen-Cilag , a pharmaceutical subsidiary of Johnson & Johnson. This is the old ChiefTech blog. Nice of you to drop in and visit.

Exclusive Cybaze ZLab – Yoroi – Hunting Cozy Bear, new campaign, old habits

Security Affairs

The researchers of Yoroi ZLab, on 16 November, accessed to a new APT29’s dangerous malware which seems to be involved in the recent wave of attacks aimed at many important US entities, such as military agencies, law enforcement, defense contractors , media companies and pharmaceutical companies.

Fake 3D printed security seals used to mask pharmaceutical heist

3ders

However, a report this week coming out of Europe has revealed that cargo thieves have found a way to clone security seals using 3D printing technology, and have used the method to successfully hijack cargo from a pharmaceutical shipment.

MY TAKE: Cyber attacks on industrial controls, operational technology have only just begun

The Last Watchdog

Damage to a nation’s critical infrastructure networks, including pharmaceutical companies, logistics firms, food production, energy or petrochemical plants can impose massive environmental, financial and psychological damage. “May you live in interesting times.” The old Chinese proverb–some consider it a blessing and others a curse–certainly describes the modern-day cyber landscape. Related: 7 attacks that put us at the brink of cyber war.

Cybaze ZLab – Yoroi team analyzed malware used in recent attacks on US entities attributed to APT29

Security Affairs

The researchers of Yoroi ZLab, on 16 November, accessed to a new APT29’s dangerous malware which seems to be involved in the recent wave of attacks aimed at many important US entities, such as military agencies, law enforcement, defense contractors , media companies and pharmaceutical companies.

Cycle Pharmaceuticals: 3D printed orphan drugs to hit market in 2-3 years

3ders

As 3D printing continues to take the medical industry by storm, one pharmaceutical company is ready to take advantage of what it sees as an exciting new business opportunity.

US DoJ indicts Chinese hackers over state-sponsored cyber espionage

Security Affairs

The two Chinese hackers and their co-conspirators also obtained unauthorized access to computers belonging to more than 25 other technology-related companies involved in industrial factory automation, radar technology, oil exploration, information technology services, pharmaceutical manufacturing, and computer processor technology, as well as the U.S.

Will Digital Healthcare Technology Disrupt Independent Physicians

Perficient Data & Analytics

for healthcare costs are physician and hospital services, diagnostic tests, and pharmaceuticals. Why fear change? Change is good and has developed the world into what it is today. Change partners with adaptation, to promote a new way of doing things. However, is change in the healthcare industry putting independent physicians at risk? With the increased usage of digital healthcare technology, will the independent physician still be able to maintain the walk-in base of customers?

Intelligent Automation Provider, Captricity, Relaunches as Vidado

Document Imaging Report

Supply chain failure – the impact on the patient

IT Governance

This concern was highlighted by recent reports indicating that pharmaceutical giant Sanofi is increasing the stockpile of medicine to allow for 14 weeks’ worth of supply should there be cross-channel transport delays.

Aprecia Pharmaceuticals receives $35M to commercialize Spritam and other 3D printed drugs

3ders

Aprecia Pharmaceuticals is the American pharmaceutical company leading the charge in 3D printed medicine.

CIPL Co-Hosts Workshop on GDPR and Scientific Health Research

Hunton Privacy

the “Workshop”) with the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and the Future of Privacy Forum (“FPF”) to address the challenges raised by the EU General Data Protection Regulation (“GDPR”) in conducting scientific health research. On October 22, 2018, the Centre for Information Policy Leadership (“CIPL”) at Hunton Andrews Kurth LLP co-hosted a workshop in Brussels on “Can GDPR Work for Health Scientific Research?” (the

Data breaches: the financial cost of poor planning

IT Governance

This reflects recent figures , suggesting that NotPetya, a 2017 ransomware attack that hit organisations across the globe, cost pharmaceutical giant Merck $135 million in lost sales in the first three months after the attack. Data breaches can have a wide-reaching impact.

Information security and compliance training for the healthcare sector

IT Governance

Pharmacies, rehabilitation care, social care, medical research and pharmaceuticals all rely on this data being available to individuals delivering their services. Healthcare is one of the hardest-hit industries when it comes to data breaches.

EOS and ASS Maschinenbau 3D printed grippers dramatically reduce waste of plastic pharmaceutical components

3ders

This article EOS and ASS Maschinenbau 3D printed grippers dramatically reduce waste of plastic pharmaceutical components is first published at 3ders.org.

Pharmaceutical researchers create new shapes for medicine tablets using 3D printing

3ders

This article Pharmaceutical researchers create new shapes for medicine tablets using 3D printing is first published at 3ders.org. Usually when we think about the medicine, vitamins and supplements that we take in pill and tablet form, one or two common shapes come to mind: in most cases it’s either an elongated oval/spherical form or a simple extruded circle. 3D Printing Applications

How To Solve The Cybersecurity Skills Shortage

Cyber Info Veritas

Sharing My Experience For example, the Pharmaceutical manufacturing company I use to work for had alliances with several community colleges to provide these hands-on experience to these students. This could spell disaster for any pharmaceutical company.

Security in a World of Physically Capable Computers

Schneier on Security

Cars, airplanes, pharmaceuticals, consumer goods, food, medical devices, workplaces, restaurants, and, most recently, financial products -- all needed government regulation in order to become safe and secure. It's no secret that computers are insecure.

Why You Should Teach Yourself Cybersecurity

Cyber Info Veritas

In highly regulated companies, such as Pharmaceuticals, their manufacturing processes are bound to procedures which are audited periodically. Successful people like to know and understand the intricacies of their subject of work.

California Consumer Privacy Act: The Challenge Ahead – Four Key Considerations for Health and Life Sciences Companies

HL Chronicle of Data Protection

Determining what is medical information and who is a provider of health care under the CMIA have long been complicated assessments for health and life science companies such as pharmaceutical and device manufacturers.

How Important Are People Skills In I.T. and Cybersecurity

Cyber Info Veritas

How to use this to your advantage for Social Engineering Prior to being a manager for the pharmaceutical company, I was a consultant IT Project Manager for several companies and industries and an IT auditor.

How the IoT will Impact Healthcare

Perficient Data & Analytics

Currently, about 30% of healthcare is dedicated to portable health monitoring, electronic health record (EHR) keeping and pharmaceutical safeguards. Let’s be honest, when it comes to our health we all want prompt and personal care. As a patient, we want the cost to be low, and the feeling of empowerment to be prevalent throughout the experience. Our world is becoming increasingly connected through the development of technology.

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