There are several important aspects of data privacy in the pharmaceutical industry. This includes the ability to protect personal information from phishing attacks, as well as virtual clinical trials. It is also vital to adhere to HIPAA rules when handling patient information.
Virtual clinical trials
Virtual clinical trials have been shown to have several advantages over conventional clinical studies. They can reduce costs, speed up timelines, and enhance data collection features. A more technologically advanced approach to drug development, virtual trials are now becoming more commonplace.
Several factors contribute to clinical delays. One of the biggest is the challenge of finding enough participants. Other challenges include significant patient fall-outs.
Although virtual trials are still in their infancy, they offer the opportunity to address both issues. The use of technology in research can improve the quality of data and ease the burden on participants, resulting in faster decision points and more efficient research.
The ability to recruit participants in a more decentralized manner is an essential step toward breaking down barriers and implementing a more patient-centric research model. Decentralized study designs can include next-gen ePRO, televisions, and device integration for continuous monitoring.
In addition to lowering operational costs, a decentralized research design can increase the diversity of the patient population. This can help to accelerate the time to market for new drugs.
To implement this new technology, CROs need a team with digital expertise. These professionals are adept in artificial intelligence and machine learning.
A key factor in facilitating the use of digital tools is an understanding of the risks of privacy and consent. Many IRBs are now comfortable with electronic informed consent tools.
Xalkori (crizotinib)
Xalkori (crizotinib) is a novel oral drug that targets anaplastic lymphoma kinase (ALK) and inhibits its tyrosine kinase activity. It also has anti-c-met receptor tyrosine kinase properties. Crizotinib was approved to treat locally advanced and metastatic non-small cell lung cancer patients.
Xalkori is a first-in-class anaplastic lymphoma kinase inhibitor. In clinical trials, it was shown to be effective in treating ALK-positive patients. Some key findings included doubling the standard of care progression-free survival and an overall response rate of 65 percent. However, the jury is still out on whether or not Xalkori is a good cancer treatment.
While the Xalkori is not yet available, it is under regulatory review in several countries worldwide. The European Medicines Agency (EMA) has endorsed the new drug, and the European Commission has approved it as a conditional marketing authorization.
While Xalkori is approved for treating ALK-positive NSCLC, it was studied only in a subset of patients with a relatively small sample size. Pfizer is currently evaluating the clinical efficacy of Xalkori and is working with the FDA to ensure its safety. Despite its approval, Xalkori still has substantial risks, and its use should be monitored for potential adverse reactions.
Many possible adverse reactions can occur with Xalkori. They are pneumonia, respiratory failure, arrhythmia, dyspnea, interstitial lung disease, and pulmonary embolism. If any of these symptoms occur, discontinue the drug immediately.
Phishing attacks
Phishing attacks are one of the most common cyber-attacks affecting the pharmaceutical industry. These attacks generally target PHI (personal health information), a valuable asset for hackers. The data can be used for insurance fraud and can also be sold on the black market.
Phishing can also include malvertising, which involves directing recipients to download malicious software, such as ransomware. Organizations need to keep up with phishing attacks to ensure that employees do not fall prey to these threats.
Phishing attacks have been used in several high-profile attacks. For instance, hackers in North Korea impersonated job recruiters on LinkedIn. They then approached staff at AstraZeneca with fake job offers.
Cybercrime has been on the rise over the last decade. The pharmaceutical industry has seen a significant increase in phishing attacks. However, many medical professionals are unaware of the risks associated with these attacks.
Increasingly, healthcare organizations are using BYOD policies. This increases the likelihood that workers will be using the organization's internet service for personal activities, which opens up the door for scammers to use private data for their own gain.
As the Internet of Things is increasingly utilized in the healthcare industry, hospitals must have strong cybersecurity infrastructure in place. In addition, several seemingly secure sites have vulnerabilities that hackers can exploit.
HIPAA
If you are a pharmaceutical company, you must follow both state and federal regulations regulating the privacy of patient information. HIPAA is the law that protects your patients' health information. But this rule does not guarantee the absolute confidentiality of your patient's records. You must use your best judgment to decide whether or not you should disclose your customer's health information.
Requesting access to an individual's PHI is an important legal right. HIPAA provides 30 days for covered entities to respond to such requests. However, in today's digital age, 30 days seems like an eternity to respond to a request. This is not because HIPAA is inflexible; instead, it recognizes that there are circumstances where additional time and effort are necessary to provide an individual with their PHI.
In addition to protecting individuals' medical records, HIPAA requires covered entities to provide individuals with copies of their PHI. This can be accomplished in paper or electronic form. Entities must also inform individuals of the approximate cost of copying their PHI. For example, a fee may include the cost of supplies and labor.
However, an individual's PHI is not considered confidential if it is a part of a record set maintained by the covered entity or by a business associate. In these cases, the same PHI can be used by both parties.
