Diagnostics as a Service is how most longevity clinics in Germany get blood analysed, and four bodies of law decide what the clinic itself may do. Each law has a different author, so a founder usually answers the four separately.
- German professional law decides who may take a venous sample and on whose instruction.
- The same professional law decides who may own the company and who has to lead it.
- The anti-kickback rules decide how the clinic and the laboratory pay each other.
- The Heilmittelwerbegesetz decides what the finished clinic may say in public.
None of this is legal advice, so a lawyer working in medical law should read your contracts and your website before either one is live.
Who may take blood in a German longevity clinic?
A venous draw is a medical service that a physician orders, and it may be delegated to trained staff who are not physicians. The Bundesärztekammer recommendation on personal performance of medical services names capillary and venous draws as delegable, so a medical assistant or a nurse may take the sample once the ordering physician has confirmed their training1.
That recommendation is specific about the confirmation. Venous draws are absent from some training catalogues, so the physician has to check what the person already knows or instruct them directly, and the physician stays responsible for the choice and the supervision. The same document expects the physician to be reachable and able to be at the practice quickly while a delegated draw happens.
Who keeps the delegation when you buy Diagnostics as a Service
A partner can supply the laboratory chain, the kits and the collection network, but the order and the delegation belong to your clinic and your named physician. Buying diagnostics as a service moves the analysis and the logistics off your books, so it never moves the responsibility for the sample.
A Heilpraktiker works under a separate permission under the Heilpraktikergesetz rather than under delegation from a physician. A clinic built that way answers a different set of questions, so confirm the scope with the responsible authority before you open.
What does the ärztliche Leitung have to cover in a longevity clinic?
The ärztliche Leitung is the named medical direction of the clinic, and it covers the indication for every test, the delegation of the draw, the supervision of the people performing it and the medical interpretation of the results. Professional law also decides who may hold the company that employs those people.
The Muster-Berufsordnung is explicit where a clinic is run as a company2. Under Section 23a only physicians and members of the professions named in Section 23b(1) may hold shares at all. That list covers other academic health professions, state-regulated health training professions, natural scientists and socio-pedagogical professions. Every shareholder has to work professionally in the company, and physicians have to hold the majority of both the shares and the voting rights. The company also has to be led responsibly by a physician, and third parties may not share in the profit. Under Section 19 a practice that employs physicians has to be led by the established physician who runs it.
For a founder who is not a physician, this is where the business plan changes shape. An outside investor with no qualifying profession may hold no stake at all, while a qualifying professional who works in the company may hold a minority one. The usual answer is that the medical work belongs to a physician or a medical company, while a separate service company holds the premises, the software and the marketing, and the two contract with each other at arm's length.
The Muster-Berufsordnung is a model rather than binding law, because each Landesärztekammer adopts its own version, so the wording that applies to you is the one your chamber published.
How is a laboratory cooperation structured without breaking the Zuweisungsverbot?
The Zuweisungsverbot is the ban on being paid for sending people or sample material to a particular provider. Section 31 of the Muster-Berufsordnung forbids a physician from asking for, accepting or granting a fee or any other benefit for that referral. Section 299a of the Strafgesetzbuch makes it a criminal offence for a member of a state-regulated healthcare profession to demand, accept or be promised a benefit. The benefit has to be in return for referring people or sample material in a way that unfairly favours somebody in competition. Section 299b makes the mirror conduct an offence for the payer, meaning offering, promising or granting that benefit, and that is the provision a laboratory or a diagnostics supplier has to answer to. Both carry up to three years or a fine, rising to five years under Section 300 in commercial or organised cases3.
Section 31 has a second half that people forget. A physician may not recommend or refer a customer to a particular laboratory, pharmacy or supplier without sufficient reason, so the clinical justification for choosing your laboratory has to be real and written down somewhere.
The structures that survive this test are the plain ones. Your clinic buys the analysis at a price that reflects the work, then bills the customer for its own service. The other clean structure is that the laboratory invoices the customer directly, and you say so before the draw, which the fee schedule for physicians requires anyway4. What never survives is a payment per referred sample, in either direction, under any name.
How a Diagnostics as a Service contract handles the payment chain
The partner contract carries anti-kickback clauses referencing Section 299a StGB and Section 31 of the model professional code. Contract wording does not by itself make an arrangement lawful, because the pricing and the substance decide that. Have counsel review the commercial terms as well as the clause itself. Section 299b binds the paying side, so ask any supplier how its contract addresses that half. The contract is between the clinic and the supplier for a service at a price, so nobody is paying anybody for a referral, which is the distinction these provisions are built on.
What may a German longevity clinic say in its advertising?
The Heilmittelwerbegesetz governs advertising for procedures and treatments whenever the advertising refers to detecting, removing or relieving an illness. Section 11 lists what advertising outside professional circles may not contain, and Section 12 bars such advertising from referring to the detection, removal or relief of the illnesses listed in the annex to the Act5. Both bind everything a customer can read, including your Instagram account.
Four items from Section 11 catch longevity clinics regularly:
- Advertising may not use endorsements from scientists or from people working in healthcare.
- Case histories are restricted where they could produce a false self-diagnosis in a reader.
- Thank-you letters and other third-party statements are restricted where their use is misleading.
- Promotional talks are banned where they are combined with selling or with collecting addresses.
Section 12 is shorter and harder. Public advertising for a procedure may not refer to the illnesses in the annex, which are notifiable infectious diseases, malignant tumours, addiction disorders other than nicotine dependence, and pathological complications of pregnancy, childbirth and the puerperium6. A longevity panel that finds cancer early is therefore not something a German clinic may advertise to the public, however carefully the sentence is worded.
Copy that avoids illness entirely can fall outside this law, but it does not escape Section 5 of the Gesetz gegen den unlauteren Wettbewerb, which covers misleading commercial claims of every kind.
How does a German longevity clinic bill a self-pay customer?
Longevity work is sold as a Selbstzahlerleistung, which is a service the customer pays for themselves because no statutory insurer covers it. Where a physician performs the medical service, the federal fee schedule for physicians decides how it is billed and what may be charged for.
Section 4 of that schedule allows a physician to charge only for services performed personally or performed under their supervision on their professional instruction4. That is the billing side of the delegation rule above, so the two answers have to match. A draw taken by an assistant is billable because a physician ordered it and supervised it, while a draw nobody ordered is neither billable nor lawful.
Private billing also asks for a written agreement before the work starts and an itemised invoice afterwards, which matters more in longevity than in most fields because the invoice is long and the customer is paying from their own account.
How much of an American longevity clinic guide applies in Germany?
The English-language founder guides are built on two American structures that have no German equivalent. Neither one can be translated, so a plan copied from them has a hole in it before the first customer arrives.
- CLIA is the American federal certification for laboratories, and German laboratory quality runs instead on the Bundesärztekammer guideline for laboratory medical examinations, usually alongside accreditation to ISO 151897.8
- Section 503A of the American food and drug law lets a pharmacy compound medicines for an individual, which is how many American longevity clinics obtain peptides and hormones9. German pharmacy and medicines law does not offer that route, so a large part of the American product mix is simply unavailable.
- American guides also assume advertising freedom that Section 11 and Section 12 remove, and they assume corporate ownership of a clinic that Section 23a restricts to physicians and a short list of qualifying professions.
What does a Diagnostics as a Service partner supply to a German clinic?
A Diagnostics as a Service partner supplies the accredited laboratory chain and the collection network, so the clinic does not build a laboratory relationship from nothing. Aniva makes over 2,500 parameters orderable across eight modalities and runs 25+ partner draw locations across Germany. Analysis is performed by an accredited laboratory partner, which holds ISO 15189 accreditation and operates under RiliBAEK. The partner offering is sold across Europe, while the consumer membership and the physical draw network are in Germany.
The rest of the package is the part founders underestimate:
- Six collection methods are available, which begin with a venous draw and a capillary kit and include saliva, stool, urine and an at-home kit.
- Infrastructure is hosted in Germany and the data processing agreement under the GDPR is included.
- The white-label console and customer dashboard carry your logo, your colours and your domain.
- A REST API, webhook events, a sandbox and developer documentation are published at docs.anivahealth.com.
- Kalia Lab runs Berlin, Hamburg and Duesseldorf on one integration of this kind.
Four weeks pass between a signed contract and the first draw, which is the number worth putting into your opening plan. Book a 30-minute demo at anivahealth.com/diagnostics if you want the contract terms and the compliance documents in front of you.
Notes and sources
Last updated: 31 August 2026
-
Bundesärztekammer and Kassenärztliche Bundesvereinigung, Persönliche Leistungserbringung: Möglichkeiten und Grenzen der Delegation ärztlicher Leistungen, section 8. bundesaerztekammer.de
-
Bundesärztekammer, (Muster-)Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte, Sections 19 and 23a. bundesaerztekammer.de
-
Section 299a and Section 299b Strafgesetzbuch, Bestechlichkeit und Bestechung im Gesundheitswesen. gesetze-im-internet.de and Section 299b
-
Section 4 Gebührenordnung für Ärzte. gesetze-im-internet.de
-
Section 11 Heilmittelwerbegesetz. gesetze-im-internet.de
-
Section 12 Heilmittelwerbegesetz and the annex to it. gesetze-im-internet.de and the annex
-
Bundesärztekammer, Richtlinie zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen (RiliBAEK). bundesaerztekammer.de
-
ISO 15189:2022, Medical laboratories, requirements for quality and competence. iso.org
-
21 U.S.C. Section 353a, Pharmacy compounding. uscode.house.gov and 42 CFR Part 493 for CLIA, ecfr.gov
