HIPAA’s Influence on Bio Tech Rules
CRISPR Therapeutics (NASDAQ: CRSP) is a CRISPR-enabled biotech company that develops the latest revolutionary treatments.
They are also bringing world-leading developments to life because of their researchers and drug developers initiating breakthroughs in human gene-based therapeutics. By accelerating their developments in their CRISPR/Cas9 gene-editing platform, they hope to eventually treat diseases such as cancer, diabetes, and more. However, there is a lot of further testing to be done for any approval just yet.
Despite these great innovative strides biotech companies create such as CRISPR Therapeutics, they need to have compliance with specific laws, rules, and regulations.
The Health Insurance Portability and Accountability Act also known as HIPAA is a federal law that was initiated in 1996 that requires companies and organizations to protect the sensitive health information of patients from being exposed without consent from the individual.
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To ensure that organizations and corporations provide compliance with the HIPAA, they must ensure the confidentiality, integrity, and availability of all electronic health information, as well as to detect and safeguard against any unwanted threats to the secure information.
There can be serious ramifications for Individuals and corporations if they violate and are not in compliance with HIPAA laws
These rules are a necessity to prevent any mistakes or information leaks from occurring that could cause damages to a patient. Public health is a key concern, hence why individuals contain the right to understand and control how their health information is used, where it goes, etc. Although, information can be used to promote high-quality health care as long as the information is protected under HIPAA rules and compliance.
Strengths and Weaknesses
CRISPR Therapeutics has an incredible amount of research and has enabled the developments of gene-based medicines fueled by CRISPR/Cas9 gene editing. They identify genetically defined diseases which they then can use an RNA to guide the CAS9 package to cut fragments of DNA in a disease-causing site.
These developments require to be heavily involved with patients, families, regulatory figures and agencies, healthcare professionals, and other organizations to ensure the highest level of transparency and safety for every entity involved to stay within HIPAA laws.
Treatments developed by CRISPR Therapeutics and their partners also do not pass DNA on to children because of the focus on somatic cells. They are primarily focused on treating patients to fit their current needs.
However, these advancements in disease therapies are not yet approved. The process of initiating laws that would allow these biotechnologies to flourish may take a long time and regulatory compliance is a necessity before any major milestones are achieved. These are still experimental and in the very early stages of development.
Another potential weakness is the controversy of gene editing. There’s a lot of talk about whether or not it’s morally or ethically right to edit an individual’s genes, especially if they are in a more fortunate situation than their peers. However, this technology should decline in price over time as cost declines take effect and more people acquire the treatments.
What’s Next for CRISPR Therapeutics?
If these treatments are approved for any individual, this could open up a whole new world of limitless possibility. Cancer, disease, and more could be effectively eliminated before any harm is caused to a patient.
There’s a lot of great possibilities that can come out of these new technologies, and they shouldn’t be overlooked. Looking forward, we can expect to see lots of oversight from regulators and governments to make sure biotech companies do not step over into uncharted territory. The HIPAA and many other laws will always protect the sensitive health information of patients throughout all biotech developments.
Overall, it seems as though that CRISPR Therapeutics is leading the biotech race to the most effective gene-based therapeutic approaches to many diseases while maintaining compliance with worldwide regulators.
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