Ensuring Data Protection and Pharma Compliance in Digital Transformation

Quicker than a storm, a pandemic has left us in a black hole of confusion and uncertainty. On this matter, pharma could be compared to a large ship that suddenly has lost its navigation in a stormy sea of changes that a new wave of digital has brought along. Various regulatory compliance pharma processes were paused, and many companies were looking for new solutions and ways to adjust to the new world. Since then, information security, pharmaceutical compliance standards, and consent management issues have become much more urgent and complex. 

Events like Next Normal Week exist to give us a landmark on how to navigate such turbulent times. We were excited to be a part of this event and share our expertise on how to secure pharma companies in terms of regulation and management of personal data thanks to the best DCF security standards – one of the hot-button topics of 2023. 

Read to discover the best practices and technical expertise that provide a robust, hyper-secure ecosystem “trained” to respect information security and pharma content compliance. 

What is Сompliance in Pharma? 

Regulatory compliance in the pharmaceutical industry refers to adherence and conformity to regulations, norms, and laws that apply to various processes in pharmaceutical companies, including marketing, operational, manufacturing, and others.

The importance of regulatory compliance in the pharmaceutical industry cannot be overstated, since pharmaceutical products and services have a huge impact on public health. 

Navigating Data Security and Pharma Compliance Challenges 

Practically all areas of the pharma industry are entirely dependent on patient and HCP data and consent gathering. Pharma companies that are optimizing their content production workflows with organizations like Digital Content Factory in place often face increasing concerns regarding data security, access management, and compliance in the pharma industry.  

The rapid shift towards digital provides many opportunities for improved content management, but at the same time, it contains a lot of risk of information leakage – which has always been one of the biggest threats for pharmaceutical companies. It comes along with a snow globe of laws and regulations that only grows every year. 

When people are talking about gathering consent, the first thing they think about is compliance. It includes multiple areas:

• The General Data Protection Regulation (GDPR)
• The California Consumer Privacy Act (CCPA) and other regulations.

The other important layer is Personal Data Management which includes gathering and storage of users’ consents, usage of systems that help us to get it (Web Forms, CRM systems, and others), Data Flow, Cyber Security, and Data Protection – the essential elements of pharma compliance, consent gathering and other pharmaceutical standards and compliance requirements. 

User experience (UX) is often overlooked but it is an important point for modern customers who are more than ever concerned with the security of their personal data. This process must be transparent enough, as according to statistics, 

95% of customers say they are more likely to be loyal to a company they trust.

At the level of UX it is important to provide opportunities for:

• Consent Gathering (Opt-in, Forms, Notifications);
• Terms of Use and Privacy Policy;
• Data Flow;
• Data Termination (Opt-out, Unsubscribe, Notifications);
• Right to be Forgotten. 

With the emergence of Artificial Intelligence, compliance in Pharma has started to change once more. Even though AI has opened a multitude of amazing opportunities, issues related to ethics, safety, and pharma data integrity compliance cannot be ignored.

The compliance requirements for pharmaceutical companies are set to shift again, and organizations should initiate the groundwork for new beginnings right now. Even though the future of pharma regulatory compliance is still vague, we know for sure that there will be many new rules and laws that offer better protection of personal data and enhance market governance.

The world of regulatory affairs is changing, and everyone is getting ready for what the future might hold for us. In such a highly regulated environment, pharma should apply all digital talents and pharmaceutical compliance management software to handle all processes in terms of data security and compliance management. Additionally, comprehensive training programs should be implemented to improve industry-based regulatory compliance across the organization. 

Why is Compliance Important in the Pharmaceutical Industry?

Security of Medical Database 

So, how to establish an effective data compliance system? According to the IntSights report,

about one-third of healthcare databases stored both locally and in the cloud are currently exposing sensitive patient data.

Factors like misconfigured databases present one of the highest risks to security of patients and doctors’ data. The problem is that many healthcare providers have continued to shift data and other assets online without prioritizing investments in cybersecurity tools or procedures to prevent the leakage of sensitive information. 

Another possible threat is an expansion of the functionality without involving certified developers. In some cases, the limitations of the budget or the wrong choice of tech providers may lead to unacceptable practices, such as reverse engineering or unauthorized extensions, which make data vulnerable. So, it is strongly recommended to involve certified professionals whenever dealing with a licensed system. 

In terms of access, businesses are increasingly focused on measures like multi-factor authentication. Security-conscious companies may further limit the number of accesses to specific IP addresses and implement manual review or confirmation systems to minimize the risk of data leaks.  

Security of Content 

While the question of security and compliance issues in the pharmaceutical industry remains urgent, customers still expect coherent messaging and best-in-class content. The secure production of pharmaceutical content needs a specific protocol of the required measures and regulations. That’s why industry leaders are currently looking for a solution that can automate these processes. 

When pharma has an idea for a new project, they need an agency to turn it into reality. But it also comes with risks, as a lot of the data contained in the marketing and promotional materials are sensitive for the pharma companies. 

While meta-tagging greatly simplifies the search for the necessary information in digital asset management (DAM), a much better solution in terms of data security would be establishing access hierarchy. Under this system, each user is provided with a specific level of access to information. 

Also, to provide additional security when working with content, agencies can sign an NDA agreement and implement monitoring through a briefing tool. This approach improves the outcomes of pharmaceutical-agency partnerships.

Even though a comprehensive brief is very important, it’s not always transmitted in a secure manner. It is much more convenient to use tools designed specifically for briefing, and that are built into the platform for working with content. 

The Brief Tool from eWizard is a valuable platform functionality used by Pharma & Life Science brand managers or marketers to provide comprehensive instructions to production partners. This tool outlines the vision for producing specific assets such as IVAs/eDetailers, Landing Pages, and Emails. It integrates pre-approved content modules and other branding elements, helps to define content structure and design expectations, ensuring the resulting production aligns with the brand’s objectives and guidelines. 

Consent Management 

Now, for the most part, the consent-gathering process is happening at the meetings with HCPs. This happens as follows: med rep asks an HCP if they are willing to receive updates from the pharma company. If the HCP is ready to share personal information – the consent-gathering process starts (see scheme 1). After that, all the data is going to the CRM or Marketing Automation system and the HCP starts getting bombarded by traffic from the pharma company.

This is the model that is basically associated with the multi-channel approach. The problem is that it does not allow differentiation of the initial interest of the HCP and provides targeted communication where each message presents a real value for the customer. 

Scheme 1

Where the change of mindset should happen

Where the change of mindset should happen 

Instead of getting a single tick from HCP that they are willing to receive further information on one channel, HCP is getting a full detailed list of the options you are offering as a service. From that moment on, the HCPs are getting targeted information that is based on their initial interest.

For example, if the HCP ticks a face-to-face visit, the information goes straight to the CRM system or the Consent Management system, depending on the infrastructure that the company is using. Then, a sales rep can process this information and plan the eDetailer presentation and further activities accordingly. 

If the HCP chooses to receive a broadcast email, it brings the whole integration with a marketing automation system. HCPs can get various types of marketing information from marketers, contractors, and other people who are in charge of this process. This practically changes the name of the game and gives the customer a broad picture of what they are signing up for and what type of information they can expect from the pharma company in exchange for consent. 

However, the other cast-iron rule is that the customer, at any minute, has a right to unsubscribe from the information they previously agreed to receive. Another key aspect of changing the mindset in the consent management process is hat with this model, customers have the option to opt out of communication through one specific channel, such as broadcast emails (see scheme 2), while still receiving information through other channels like portals and events. By using this checkbox, the company may deactivate undesirable activities without interrupting an entire communication with the HCP. 

Scheme 2

This way, we can generate the golden rule of consent management: the customer should always be provided with transparency regarding the use of their data, communication channels used, and meaning behind each checkbox they choose. 

Which ISO is for the Pharmaceutical Industry? 

The International Standards Organization (ISO) means that the company has implemented a number of procedures, policies, and guidelines, allowing it to attain robust control and protection over the company’s assets. Thanks to ISO, we can guarantee complete pharma regulatory compliance. 

There are a few other certifications that pharmaceutical companies must have to continue operating safely and without causing any harm to their clients and patients. Here is a short list of those certifications: 

• ISO 45001

This certification helps create a safe environment for employees and reduces various health and safety risks. 

• ISO 9001

This standard specifies the requirements for Quality Management Systems. Before launching a new pharmaceutical product, it’s crucial to ensure that it complies with all applicable regulatory requirements to guarantee its safety and efficacy, and this is what this certification is responsible for. 

• ISO 14001

With this certification, companies can improve their environmental performance and mitigate environmental harm. 

Pharma regulatory and compliance guidelines are constantly evolving, requiring many organizations to stay updated with the latest industry standards. Pharmaceutical companies manage a huge amount of sensitive information that cannot be disclosed. Today, the need to remain competitive and provide a secure environment for pharma customers prompts us to be certified against a strictly defined and delineated standard which is ISO/IEC 27001. 

Viseven has successfully passed the first supervisory audit ISO 27001. Among the main advantages of adhering to the completed pharmaceutical compliance certification norms and pharma compliance regulations are asset protection from leakage, theft, or loss; higher trust from the customers, as well as employees’ confidence. All of this ensures our greater strength in the highly competitive landscape, with clear and transparent workflows, as well as role distribution among our specialists. 

In case you have questions concerning our expertise in establishing a robust hyper-secure ecosystem – turn to our experts for insights and guidance. 

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