The case for more competition and standards

The German Association of Health and IT Vendors, bvitg e.V. (bvitg) advocates for clear legal guidelines and fair competition. That in mind, the motion to amend the Appointments Service and Care Act (TSVG) warrants critical examination. It is vital to take into account the structures and standards already defined by science worldwide.

The trend toward patient emancipation has given rise to lively competition as to who has the authority to determine the nature and operation of digital patient records. The subject of health IT has rarely been as dynamic, exciting, and relevant as it is today. Different actors are positioning themselves and staking claims based on their own situations, for example health insurance companies that have launched an idea competition with various solutions.

Meanwhile, Germany’s Federal Ministry of Health (BMG) submitted the first draft of the TSVG this past year. The strategic importance that the BMG attributes to the use of electronic patient records (EPAs) is evident from its demand that statutory health insurance companies offer their members a gematik-certified EPA by January 1, 2021.

The TSVG presupposes adoption of an EPA, but current legal regulations do not address the diverse life circumstances of insurance plan members. There are still numerous unresolved questions regarding the possible situations within the insurance relationship. In addition, bvitg wants fair competition among all patient record providers. Making insurance companies the sole providers of EPAs would be detrimental to competition, impede innovation, and push out established solutions. IT companies have been providing care-focused solutions for many years now, supporting users in all types of outpatient, inpatient, and rehabilitative care facilities. Physicians and psychotherapists can work with their patients to choose the appropriate solution from the products on offer. The success or failure of the EPA will ultimately be determined by customization, a legally sound approach to data protection, and a fair compensation policy.

The electronic patient record not only gives the insured access to their data, but also makes them “managers of their own health” in consultation with their service providers.

The EPA specifications proposed by gematik in December unfortunately ignore market requirements. On the one hand, it is of limited use to insurance plan members and service providers; on the other, the certification standards for manufacturers are high and involve significant costs. Established vendors are therefore considering very carefully whether they want to enter into this competitive environment and if so, how. Start-ups, on the other hand, get no opportunities at all. Thus, bvitg sees a need for adjustments and discussion in this area.

In addition, bvitg regards the proposed amendment to the TSVG as highly critical. It calls for the National Association of Statutory Health Insurance Physicians (KBV) to assume responsibility for determining the medical content and technical parameters for data exchange. In the first place, this completely ignores the fact that such structures have long since been defined by scientists in professional medical societies and the field of medical informatics; in addition, the most recent KBV specification projects demonstrate that solutions whose development involves substantial investment of resources disregard the demands of the market.

Therefore, bvitg is in favor of imposing a reasonable and transparent process on the KBV for making its determinations, and one that involves expertise and standardization approaches from science and industry — from the very beginning. The BMG in turn should validate the process as a neutral party and thus ensure high-quality results. This is the only way to generate acceptance in the end and develop solutions that are usable and cost-effective in actual practice and facilitate secure and beneficial networked healthcare.

To achieve lasting success, the EPA should be integrated into healthcare with particular conscientiousness, but as soon as possible. The benefits of digitization must appeal to the insured, because their only goal is to be healthy.