On August 16, the Federal Pharmacy Council (CFF) published Resolution 10/24, which regulates the attributions and capabilities of pharmaceutical professionals in activities involving digital health tools and artificial intelligence.

The resolution is already in force and establishes that digital health is a field of knowledge and practice associated with using Information and Communication Technology (TIC) for research, development and innovation. The concept also covers the appropriate and sustainable use of products and services capable of improving clinical outcomes, quality of life and economic viability for individuals, families, communities, institutions, public or private organizations.

Digital health products and services cover different areas regulated by the CFF, such as:

  • Assistance (disease prevention, health promotion, protection and recovery; self-care and patient engagement);
  • Clinical analysis;
  • Pharmaceutical care, clinical pharmacy and compounding pharmacy;
  • Telepharmacy and telehealth;
  • Research & development;
  • Education; and
  • Management, governance, logistics and entrepreneurship.

The main definitions in Resolution 10/24 include:

  • Digital medicine and digital therapeutics (DTx): software as a medical device (SaMD) that treats, manages or prevents diseases or disorders - independently or in combination with medicines - and that is authorized by the Brazilian Health Regulatory Agency (Anvisa).

SaMDs are defined by Anvisa as any software intended for one or more of the following purposes:

  • the diagnosis, prevention, monitoring, treatment (or relief) of a disease;
  • the diagnosis, monitoring, treatment or repair of an injury or disability;
  • investigation, replacement, alteration of anatomy or a physiological or pathological process or state;
  • the support or maintenance of life;
  • the control or support of conception; or
  • the provision of information using in vitro examination of samples from the human body, including organ and tissue donations.
  • Predictive analysis: using data, statistical algorithms, and machine learning techniques to identify the probability of future results based on historical data. It is applied to digital health to obtain predictions and answers to health needs.
  • Machine learning: a subfield of artificial intelligence that involves the creation of computer models capable of interpreting data sets. These models adapt and improve their performance over time without direct human intervention, using algorithms that identify patterns and characteristics in the data.
  • Artificial Intelligence (IA): technology that gives a computer the ability to perform tasks normally associated with intelligent individuals. It can simulate the human capacity to reason, learn, perceive, and deliberate. In healthcare, IA can be used for a variety of purposes, such as recommendations, pattern perception, and decision support.
  • Big data: a term that describes extremely large and complex data sets - structured and unstructured - that are difficult to process using traditional data processing techniques. Once analyzed, this data makes it possible to make more informed and strategic decisions in healthcare. Big data in digital health can include, for example, data from electronic medical records, test results, genetic data, and epidemiological data, among others.

The pharmacist's duties in digital health

According to the new resolution, pharmacists can figure as Technical Director (RT) for digital health products and services. Specifically in the case of SaMD which works as DTx, these products must also have an established legal representation in Brazil and be registered with the respective RT's Regional Pharmacy Council (CRF).

In addition, the new regulation expressly allows the pharmaceutical prescription of digital health products and services (including DTx), as long as it is based on scientific evidence, to promote clinical safety and patient benefit.

Other responsibilities provided for in Resolution 10/24 for pharmaceutical professionals working in digital health include:

  • Develop DTx, ensuring clinical efficacy and safety in their development;
  • Promote quality, clinical safety, and clinical efficacy of products and services;
  • Review, approve, and ensure that information related to diseases, medicines, and therapies on digital platforms is accurate, up-to-date, and complies with regulations, clinical guidelines, and health evidence;
  • Promoting interoperability between systems and platforms for effective communication and data exchange between different technologies and health service providers;
  • Guide users and patients on the characteristics, benefits, risks, and limitations of products and services; and
  • Report adverse events, technical failures, or quality deviations associated with digital health products and services to the competent health authorities.

The pharmacist's duties in AI

The use of AI by pharmacists is expressly authorized in the new regulation, as long as it complies with ethical principles, clinical safety, and the protection of patients' personal data.

These professionals are also allowed to participate in the development of AI algorithms at all stages, including research, conception, feasibility, development, testing, non-clinical and clinical validation, regulatory affairs, implementation, maintenance, support, updating, post-market monitoring, and discontinuation.

Other duties provided in the resolution include ensuring the clinical validation of AI systems and that machine intervention does not replace the pharmacist's clinical judgment. Its use is limited to decision support.

The Life Sciences & Health practice can provide more information on the topic.