The BioTech and pharmaceutical industries are facing a rising tide of ever-stringent regulatory requirements. This mass of data privacy and security regulations can be tricky to navigate, especially for organisations that operate in various territories. We're sure you've noticed that consumers and customers are increasingly savvier to the restrictions of these regulations, which increases the need for healthcare firms to meet their security and user experience demands.
The more regulations businesses face, the greater their need for technologies that help them keep their data in order. It’s now critical to know where data resides, who has access to it and ensure all information is stored in the correct place.
The current regulatory landscape at a glance
The various laws and regulations that biotech and pharma organisations now need to comply with are long and wide-ranging. They include industry regulations, vertical-specific restrictions and additional data privacy and security laws.
CCPA: The California Consumer Privacy Act is a customer privacy regulation that came into effect in January 2020. It gives consumers the right to request what personal information a business has collected. It also enables consumers to prevent firms from passing their data to third-party businesses and demand a list of organisations that have their data. CCPA applies to any organisation whose customers reside in California, have more than $25 million annual revenues and hold personal data of more than 50,000 people.
GDPR: The European Union’s General Data Protection Requirement was introduced in May 2018 to restrict how organisations collect, handle and store peoples’ private information. GDPR ensures businesses document the information they collect and process effectively, as well as how long they keep data for and the security measures they have in place to protect it. Any business that holds data belonging to people in the EU or has customers in Europe must comply with this regulation. The regulation ensures companies have the right processes in place to respond to data breaches, heavily punishes those that do suffer a breach and necessitates proper reporting of an incident.
HIPAA: The Health Insurance Portability and Accountability Act was implemented in 1996 to impose strict restrictions on the privacy and security of online health information. The regulation protects the individually identifiable health information that businesses create, receive, maintain and transmit electronically. It applies to any healthcare provider and health plan that operates in the United States.
European regulatory system: The European regulatory system for medicines ensures the safe building and distribution of pharmaceutical products. It consists of a European medicines regulatory network, which is a partnership between the European Commission, the European Medicines Agency and various medicines regulatory authorities across Europe. The network ensures EU patients have access to effective, high-quality and safe medicines.
How proper email management can keep you compliant
This growing list of data regulations may seem overwhelming, but it’s essential to protect personal and business data in the modern world. The biggest companies meet the demands of these regulations not only to ensure compliance but also to enhance user experiences and interactions.
And, the vast majority of these businesses’ correspondence resides in email systems, including contracts, project agreements, patient requests and collaboration between staff. This information needs to be made available and easily discoverable by anyone who might need access to it.
Discover how Mail Manager can help your BioTech or pharma firm bring clarity to your email and document management with a free trial, or download our eBook "The BioTech industry's guide to effective email management".