Real World Data (RWD) is data collected in the real world about patient health and healthcare delivery. This data can be collected routinely from a variety of sources including electronic health records, disease registries or patient generated and uploaded data. RWD allows for the collection of more data from actual users of medicinal substances. Real World Evidence (RWE) is clinical evidence that has been carried out on the basis of RWD analysis. They concern the benefits or risks of using a medicinal product. RWE is obtained from various studies and analyses such as randomised trials, including large simple trials, pragmatic trials or observational studies. They can be used to determine what action should be taken to reduce the risks and increase the benefits of a medicine for therapeutic purposes. RWE has been defined in Sec. 3022 (2) of the 21st Century Cures Act: ‘real world evidence’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials. Clinical trials are now at the heart of the process of bringing medicinal products and medical devices into use. For the most part, they are conducted even before a product is placed on the market, but the final, fourth phase takes place after the product is marketed. This phase consists of determining whether the marketed product is safe in all manufacturer’s indications and for all patient groups. Conclusions from previous phases are further verified in this phase. In the earlier phases, studies are conducted on a group of volunteers on whom the effects of the substance are tested. In the final phase, information is collected on adverse drug effects that have been reported. In this aspect, RWE and clinical trials are similar. However, there is one important difference that weighs in favour of RWE. In the case of clinical trials, data are collected only from patients who have reported adverse effects and the information about them has reached the manufacturer. RWD can be collected from all patients who reported an adverse reaction to a medicine and the adverse reaction was reported in their medical records. The number of people from whom data on the effects of medicines are derived is therefore much larger than in the case of clinical trials. Manufacturers of medicinal products and medical devices use RWD and RWE to support clinical trials, especially their final phase. They are therefore not mutually exclusive modes of research, but rather designed to support each other.
On August 2, 2021, Poland submitted to the European Commission an application for a derogation pursuant to Art. 395 of Council Directive 2006/112/EC on the common system of value added tax to authorize the application of a measure derogating from Art. 218 and 232 of that directive.
On 30 March 2022 the European Commission, based on the application, prepared and submitted to the EU Council a draft derogation decision authorizing Poland to implement the mandatory electronic invoicing system.
The Polish Ministry of Finance is working on the business and legal concept of the target National System of Electronic Invoicing. The assumption is the fullest possible use of the potential of electronic invoicing within the scope of consent granted to Poland by the EU institutions.
The project of the Polish company based on deep neural networks allows to automatically search for trolls in the network and fight disinformation. It will also evaluate and predict, as well as suggest an effective form of business publication on social networking sites.
Fighting online disinformation is a huge challenge, both for social networking sites and for business. On the other hand, it is a huge threat to users, but also to entire communities, organizations, countries and companies. Various types of disinformation campaigns can hit not only politicians directly, but also national minorities.
Embedded finance allows to pay for a purchase online without entering bank details or instantly take out a consumer loan on digital platforms outside banks, among many other options. This Bank-as-a-Service model, which allows the integration of financial services via APIs, moved $22.5 billion in 2020, a figure that will increase tenfold in the next four years.
To meet the rising demand for embedded finance, financial institutions are increasingly offering banking as a service (BaaS)—bundled offerings, often white-labeled or cobranded services, that nonbanks can use to serve their customers. Making it work will require new technologies and capabilities, because BaaS is usually distributed to clients via APIs and requires strong risk and compliance management of the embedded finance partner. (Fintechs offering to intermediate BaaS relationships also have emerged; examples include Treasury Prime, Synctera, Unit, and Bond.) Banks will also need new business models, such as pay-for-use monetization, B2B2C and B2B2B distribution capabilities, and a careful consideration of branding.
We are entering 2022 by fighting on at least two fronts: the still present pandemic and sanctions disrupting the current global economy. This could not but have had an impact on the international investment market, which is now facing a difficult challenge.
For many years, the world’s most popular emerging markets have been the so-called BRICS: Brazil, Russia, India, China and South Africa. But given that Russia is no longer a market that Westerners can access following the invasion of Ukraine, it might be time for investors to stop lumping all of the emerging markets together.
