PatientMetRx® Blog

Regulatory & Compliance

As a data-driven company, we follow global regulatory standards relevant within the US and EU such as GDPR and HIPAA.
August 13, 2021

Overview

At Talking Medicines, we understand how regulated the pharmaceutical industry is, and understand that within the industry there are many unclear areas around Artificial Intelligence (AI). We are closely following the guidance around this from regulators, taking advice from their available guidelines.

As pioneers into developing machine learning, we extract the unwanted noise such as (professional voices, spam data) from data posts to provide clarity of the patient’s voice, which is what makes us different to other companies. We are setting accuracy standards, for Machine Learning that ensure that data consistency and quality of the product is sustained through the lifetime of the product.

This way our customers can have the confidence in knowing that the data they are seeing accurately represents the patient voice.

Regulatory Agencies

We work closely with regulators and BHBIA and ABPI, attending regular meetings and seminars ensuring that we understand new legislation that could impact on the data and product.

The use of Artificial Intelligence and machine learning within research and development (R&D) is becoming more openly discussed and recognised. There are a number of regulators that are discussing this, aiming to produce further guidance in the future on the best practices in using social media data, data mining and the use of AI to set standards that can be used globally.

The European Commission have prepared Trustworthy AI Ethical Guidelines for ensuring three major practices are adhered to:

(1) lawful – respecting all applicable laws and regulations

(2) ethical – respecting ethical principles and values

(3) robust – both from a technical perspective while taking into account its social environment

Please see the below link for more details.

European Commission Guidelines

Other agencies such as the FDA, EMA and other regulatory groups are now beginning to take look into the use of data text mining and artificial intelligence (AI) and how this can improve the current data collection from the traditional methods used in e.g. clinical research. The use of these technology methods can help reduce the reporting, manual errors.

At Talking Medicines, we have transparency of data, respect ethical principles, take data protection seriously and ensure that we use only the best companies to secure our data.

Pharmacovigilance and Patient Safety

Talking Medicines understands how important patients’ safety is. We do not collate personalised data for PatientMetRx® that can be reported as suspected Adverse Events to the regulatory

authorities such as the MHRA or the FDA. The data used to make up the patient voice does not equate to the level of detail to report out adverse events such as, patient identifiers, severity, causality, relationship to drug, start/stop date/ongoing etc.

“Unidentifiable patient data is collected from social media at scale. There are no Adverse Events from the PatientMetRx® data insights service”

We are looking at information such as feelings, emotions to measure what the person feels about a particular medication, this information can help the pharmaceutical industry keep in touch with the patient populations and market their products according to negative and positive patient’s feedback.

Talking Medicines will continue to follow FDA and MHRA guidance to ensure that we are compliant with any regulations around the use of social media data and AI.

Data Safety & Security

AI adds a new level of complexity compared with traditional kinds of IT systems. The ICO has guidelines providing guidance to companies using AI. The below link to the ICO website.

Guide to Data Protection

We work closely with the Data Protection Officers, using the Data Protection Impact Assessment (DPIA) to identify and minimise the data protection risks. It is our responsibility to ensure that data is secure and that we can remove data or report data breaches as and when required.

Regulatory Quality Assurance

We have quality control steps throughout the data and product, for every major change in the product we take advice from our regulatory partners for quality assurance, ensuring that we meet with the standards expected under their guidance.

In the interest of transparency, we have a number of compliance reports and documents that are readily available for inspections.

If you have any further questions regarding regulatory & compliance at Talking Medicines, we welcome you to book in for a chat with a member of the team here.

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