Four Ways to Develop Innovative PSPs While Staying in Compliance

Improving patient care has become a priority for healthcare organizations with the goal of better serving patients and achieving patient satisfaction. However, it is crucial to balance innovation and compliance. While developing revolutionary technology for patients, health organizations need to ensure that these innovations are compliant, ethical and analyze the regulatory impact and risks these innovations could bring.

As PSP practices are varied across the region, there is no one-size-fits-all model for PSP. In fact, there are not a lot of legal precedents related to PSP in Asia.

The absence of specific rules is also an added concern that raises further challenges to creating effective PSPs. One of the reasons why many do not have an effective and strong PSP compliance program in place is because the extensive rules are not there. It is challenging to create those rules and that is where professionals can come in and help.

There must be practical steps taken to create the required rules and ensure that we balance innovation and compliance. For this to happen, an organization must be very clear on the objectives of a PSP.

Review on what the program is for while maintaining a focus on delivering benefits to patients. The driving force behind a PSP must not be to simply increase marketing activities or branding of the business. Rather, it is all about patient benefits and needs – PSP should allow patients to be actively engaged in their health care for better health outcomes and better quality of life.

The organization must be clear about the risks arising from a particular PSP setup and to the business. Map these risks in the context of patient solutions, for example, interference between the communications between the provider and a patient in the PSP context.

But these risk factors will vary between jurisdictions; so, it is important to create a tailored program and identify the higher risk areas given the way the PSPs might be run and then focus on those risk areas. Other risk areas may include the independence of decision-making and independence of patient identification. Conflict of interest is another risk area, along with the risk of inducements and data privacy. Another key area is equal access.

Once all risks have been identified, then it is a matter of working through the scenarios and developing a system, a set of rules, and procedures to address each of these risk areas in the context in which the PSP is utilized.

Having clear responsibilities is important, especially in a program where you are at the cutting edge and constantly pushing the limits. Having strong buy-in with employees is important.

Audits that put stress on the system in place and try to find weaknesses in what has been developed are important measures. These include random audits, stepping back and taking stock to look at where the program stands, identifying the weaknesses, and of course, updating and improving the program. Technology is becoming more crucial in conducting effective audits in the compliance space.

A very important part of ensuring an effective PSP system is people skills. You must make sure that stakeholders truly understand the rationale and objectives of the program. The purpose here is to promote high ethical standards.

Every company has a purpose, values, and code of conduct. For example, DKSH’s purpose to enrich people's lives helps to make sure that the ethical norms and the ethical bar are set even higher. Non-compliance can be expensive; fines, FCPA resolutions and settlements, deferred prosecution agreements, costs of external monitors, and costs of reviews and audits.