12 tips for DiGA approval in 2024
12 年批准 DiGA 的 2024 個技巧
September 10, 2024
9月10， 2024
Contact person:Malte Bucksch
聯繫人：MalteBucksch
Implementing a digital health application (DiGA) involves effort and costs that should ultimately be worth it for your company.
實施 數位健康應用程式 （DiGA） 涉及工作量和成本，最終對您的公司來說應該是值得的。
And in fact – many certified DiGAs that make it onto the market show extremely positive prescription and sales figures . Others, however, do not receive admission or fail before submitting their application. But why is it like that? What factors influence the failure or success of your DiGA ? In this article we summarize the most important factors and recommendations that you should consider in 2023 when planning and implementing your DiGA, including approval .
事實上 - 許多進入市場的認證 DiGA 都顯示出非常 積極的處方和銷售數據 。 然而，其他人在提交申請之前沒有被錄取或不及格。但為什麼會這樣呢？哪些因素會影響 DiGA 的成敗 ？ 在本文中，我們總結了您在 2023 年規劃和實施 DiGA 時應考慮的最重要 因素 和 建議 ，包括 批准 。
1. Plan your clinical trial adequately
1. 充分規劃您的臨床試驗
In the startup sector, there are many influential paradigms that allow entrepreneurs to increase the probability of success of their own company:
在創業領域，有許多有影響力的範式可以讓企業家增加自己公司成功的可能性：
“Move fast and break things” (Facebook)
“快速行動，打破常規”（Facebook）
“Responding to change over following a plan” (Agile Software Development Manifesto)
」回應變化而不是遵循計劃“（敏捷軟體開發宣言）
“Fail Faster”
“失敗得更快”
These mantras and strategies are extremely helpful and important in certain contexts. However, when it comes to planning a medical product or a DiGA, advance planning is much more important than in the classic software startup sector.
這些咒語和策略在某些情況下非常有用和重要。然而，在規劃醫療產品或 DiGA 時，提前規劃比經典的軟體創業領域要重要得多。
Your DiGA must prove the positive care effect in a clinical study in order to receive certification and thus be permanently listed in the directory. These studies are very time-consuming and costly, which is why the budget is often only sufficient for one or two studies. Therefore, you can only try out or evaluate a limited number of product approaches. The pressure is increasing that the first approach must be the right one. Accordingly, you need to plan sufficiently to increase the probability of success of this approach.
您的 DiGA 必須在臨床研究中證明積極的護理效果，才能獲得認證，從而永久列入目錄。這些研究非常耗時且成本高昂，這就是為什麼預算通常只夠一兩項研究的原因。因此，您只能嘗試或評估有限數量的產品方法。壓力越來越大，第一種方法必須是正確的方法。因此，您需要進行充分的規劃，以增加此方法成功的可能性。
The planning of the DiGA should of course also take into account the results of any qualitative and quantitative user research. You can consider different approaches when starting out. However, once you choose one, changing direction is much more difficult.
DiGA 的規劃 當然還應考慮任何定性和定量使用者研究的結果。開始時，您可以考慮不同的方法。但是，一旦你選擇一個，改變方向就要困難得多。
Aside from the product concept, it is also important to pay attention to quality in the study. As you probably know, you need to do a comparative study. The following questions, among others, need to be answered here:
除了產品概念外，在研究中關注品質也很重要。您可能知道，您需要進行比較研究。除其他問題外，此處需要回答以下問題：
How large should the sample be?
樣品應該有多大？
For which patient group (ICD code) do you specifically want to obtain evidence?
您特別希望為哪個患者群體（ICD 代碼）獲取證據？
How do you gain access to this patient group?
您如何訪問此患者組？
What does their current supply reality look like?
他們目前的供應現實是什麼樣的？
What ethical concerns are there with the study?
這項研究存在哪些倫理問題？
How many comparison groups do you need?
您需要多少個比較組？
How is the group assignment of the test subjects carried out?
測試物件的分組分配是如何進行的？
Which endpoints should you specifically measure – and how do you want to collect them?
您應該專門測量哪些終端節點 – 以及如何收集它們？
How long does the DiGA have to be used to prove a positive supply effect?
DiGA 必須使用多長時間才能證明積極的供應效應？
What supply effect should your DiGA actually achieve?
您的 DiGA 實際上應該達到什麼樣的供應效果？
It is best to look for a reliable partner for the clinical study who has experience specifically with DiGA and software studies. You can find out how a clinical evaluation works within the framework of the MDR in this article .
最好為臨床研究尋找一個可靠的合作夥伴，他具有 DiGA 和軟體研究方面的專門經驗。您可以在 本文 中 了解臨床評估在 MDR 框架內的工作原理。
In addition, after the end of the trial period, price negotiations with the National Association of Statutory Health Insurance Funds will take place. This is where you decide how lucrative your application will be in the long term. The quality of your study and the strength of the positive supply effect are extremely important negotiating arguments that enable you to achieve a permanently higher DiGA price.
此外，試用期結束后，將與全國法定健康保險基金協會進行價格談判。這是您決定您的應用程式從長遠來看有多有利可圖的地方。您的研究質量和積極供應效應的強度是極其重要的談判論點，使您能夠獲得永久更高的 DiGA 價格。
If the draft of the digital law, which will probably be passed in February 2024, is anything to go by, then 20% of the price will also depend on the success measurement accompanying the application: only DiGA that can demonstrate a long period of use or adherence, for example, will achieve the full negotiated price Price. You can read all the important changes brought about by the Digital Act in our blog article Draft of the Digital Act: Effects of DigiG for DiGA manufacturers .
如果可能於 2024 年 2 月通過的數位法律草案有任何可參考之處，那麼 20% 的價格也將取決於申請隨附的成功衡量標準： 例如，只有能夠證明長期使用或遵守的 DiGA 才能達到完整的協商價格價格。您可以在我們的 博客文章《數位法案草案：DigiG 對 DiGA 製造商 的影響》中閱讀《數位法案》帶來的所有重要變化。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Check whether there is existing scientific evidence that suggests that your DiGA can demonstrate a positive care effect - and if so, what this looks like. Carry out initial qualitative and quantitative studies to generate additional data for product conception. Also, plan the study design really well (with a CRO if necessary) so that you don't have to expect any surprises during or at the end of the study. The cleaner your methodical approach, the greater the chance of getting permanent approval and negotiating a higher price for your DiGA
檢查是否有現有的科學證據表明您的 DiGA 可以表現出積極的護理效果 - 如果有，這是什麼樣子。進行初步的定性和定量研究，為產品構思生成額外的數據。此外，要很好地規劃研究設計（如有必要，請使用 CRO），這樣您就不必在研究期間或結束時期待任何意外。您的方法越簡潔，獲得永久批准和為您的 DiGA 談判更高價格的機會就越大.
Without an indication and a clinical study, there is no certification as a DiGA - but what about offers that serve prevention ? By creating the framework for digital prevention and health promotion offers, the legislature has closed an important gap that the DiGA concept left open as a purely curative application. Also read our blog article on the topic of certification of digital courses according to the Central Prevention Testing Center (ZPP).
沒有適應症和臨床研究，就沒有 DiGA 認證 - 但是用於 預防 的優惠呢？ 通過創建數位預防和健康促進服務的框架，立法機構縮小了 DiGA 概念作為純粹治療應用而留下的重要差距。另請閱讀我們 關於根據中央預防測試中心 （ZPP） 進行數位課程認證主題的博客文章。
2. Work with the right advisors
2. 與合適的顧問合作
Especially in the medical device sector, you should look for partners who can provide you with targeted advice. Bad consultants cost you a huge amount of time and money. Good consultants will help you get to the market quickly and cost-effectively.
尤其是在醫療器械領域，您應該尋找能夠為您提供針對性建議的合作夥伴。糟糕的顧問會花費您大量的時間和金錢。優秀的顧問將説明您快速且經濟高效地進入市場。
Unsuitable consultants are characterized by the following characteristics, for example. She …
例如，不合適的顧問具有以下特徵。她。。。
... have little prior knowledge of standalone software. For example, the consultants come from the hardware sector and have difficulty understanding the complexity and mindset in standalone software development.
...對獨立軟體知之甚少。例如，顧問來自硬體行業，難以理解獨立軟體開發的複雜性和思維方式。
... have no experience with agile development, especially not in relation to medical devices.
...沒有敏捷開發經驗，尤其是沒有與醫療設備相關的敏捷開發經驗。
...explain things in an unnecessarily complicated manner and do not show a clear path to implementation.
...以不必要的複雜方式解釋事情，並且沒有顯示明確的實施路徑。
... artificially increase consulting costs by making themselves irreplaceable. You block the transfer of knowledge to your company either knowingly or unknowingly.
...通過使自身不可替代來人為地增加諮詢成本。您有意或無意地阻止了知識向公司轉移。
Good advisors, on the other hand...
另一方面，優秀的顧問......
... find pragmatic solutions that can be implemented creatively and concretely.
...尋找可以創造性和具體地實施的務實解決方案。
... know the rules and know how to follow them without burning resources unnecessarily.
...了解規則並知道如何遵守它們，而不會不必要地消耗資源。
... develop solutions that fit your company instead of forcing your standard procedures on you.
...開發適合您公司的解決方案，而不是將您的標準程序強加給您。
... explain things in simple language and thus enable knowledge to be passed on to your team.
...用簡單的語言解釋事物，從而將知識傳遞給您的團隊。
... make yourself superfluous little by little, so that your team will eventually stand on its own two feet.
...讓自己一點一點變得多餘，這樣你的團隊最終會自力更生。
... don't organize a multi-day workshop for every small problem, but rather help efficiently to find a solution.
...不要為每個小問題組織為期多天的研討會，而是有效地説明找到解決方案。
Don't forget that every month that you are not listed as DiGA, you don't earn any money, but you still have costs. Therefore, good advice is absolutely integral to the success of your product.
不要忘記，您沒有被列為 DiGA 的每個月，您都不會賺到任何錢，但您仍然有成本。因此，好的建議絕對是你產品成功不可或缺的一部分。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Ask your network for recommendations or contact us. We will help you with all DiGA and medical device topics or, if necessary, provide you with trustworthy advisors for your problem.
向您的網路尋求建議或聯繫我們。我們將幫助您解決所有 DiGA 和醫療器械主題，或者在必要時為您的問題提供值得信賴的顧問。
3. Target risk class I
3. 目標風險等級 I
At times there was a rumor that there would hardly be any risk class I software medical products left under MDR. This (fortunately) turned out to be wrong. To date, almost all applications approved under MDR are assigned to risk class I in the DiGA directory. You can get a concrete overview of this in our DiGA directory for manufacturers and on our DiGA dashboard
有時有傳言說，在 MDR 下幾乎沒有任何風險等級的 I 級軟體醫療產品。這（幸運的是）被證明是錯誤的。迄今為止，幾乎所有根據 MDR 批准的申請都被分配到 DiGA 目錄中的風險類別 I 。您可以在我們的 製造商 DiGA 目錄和我們的 DiGA 儀錶板上獲得具體概述 .
Whether your DiGA also falls into risk class I depends on various factors. Please read our guide to the classification of software medical devices according to MDR . In general, software in risk class IIa or IIb involves considerable additional effort and additional costs for certification with a notified body. It is worthwhile to design the application in such a way that approval takes place under risk class I.
您的 DiGA 是否也屬於風險等級 I 取決於各種因素。請閱讀我們的 根據 MDR 對軟體醫療器械進行分類 指南。一般來說，風險等級 IIa 或 IIb 的軟體需要付出相當大的額外努力和額外的費用才能獲得公告機構的認證。在設計應用程式時，應確保在風險等級 I 下進行審批。
We would be happy to advise you on this and evaluate whether risk class I could work for your product.
我們很樂意就此為您提供建議，並評估風險等級 I 是否適用於您的產品。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Define your application so that classification according to risk class I is possible. From risk class IIa onwards, you will have to put in considerably more effort.
定義您的應用，以便根據風險等級 I 進行分類。從風險等級 IIa 開始，您將需要付出更多的努力。
4. Don't underestimate the challenges in selling your DiGA
4. 不要低估銷售 DiGA 的挑戰
If your DiGA has been successfully included in the BfArM directory, it does not automatically mean that doctors will also prescribe it. And if your DiGA is not prescribed by doctors and patients do not become aware of the application themselves, you have no users and therefore no sales.
如果您的 DiGA 已成功包含在 BfArM 目錄中，這並不意味著醫生也會開處方。如果您的 DiGA 不是由醫生開處方的，並且患者自己沒有意識到該應用程式，那麼您就沒有使用者，因此沒有銷售。
The marketing and distribution of DiGA is a challenge for many manufacturers. The entire DiGA concept is still very new and little known among doctors and patients. As a manufacturer, you must actively contribute to ensuring that doctors and/or patients understand your product and at the same time see the individual added value.
DiGA 的行銷和分銷 對許多製造商來說都是一個挑戰。整個 DiGA 概念仍然非常新，在醫生和患者中鮮為人知。作為製造商，您必須積極做出貢獻，確保醫生和/或患者瞭解您的產品，同時看到個人的附加值。
There are many approaches to this: specialized medical conferences, cooperation with pharmaceutical companies, offering DiGA seminars for doctors and other, more classic advertising measures.
有很多方法可以做到這一點：專門的醫學會議、與製藥公司的合作、為醫生提供 DiGA 研討會以及其他更經典的廣告措施。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Certification and approval alone are not enough: plan the distribution of your DiGA and think about how your company can gain access to doctors and patients. Also be aware of what interests these target groups have and what arguments can best be used to convince them.
僅靠認證和批准是不夠的：規劃 DiGA 的分發，並考慮您的公司如何獲得醫生和患者的服務。還要注意這些目標群體的利益是什麼，以及哪些論點最能用來說服他們。
Please also read our blog article on DiGA marketing and sales , in which we go into detail about the specific requirements for successful marketing of DiGA
另請閱讀我們關於 DiGA 行銷和銷售的博客文章，其中我們詳細介紹了 DiGA 成功行銷的具體要求.
5. Choose a server provider in the EU
5. 選擇歐盟的伺服器供應商
The GDPR poses major challenges for all companies operating in the EU. And the protection of personal data is of course particularly important in the healthcare sector. That is why the BfArM also sets additional requirements for data protection in the DiGA area for approval.
GDPR 對在歐盟運營的所有公司都構成了重大挑戰。當然，個人數據的保護在醫療保健領域尤為重要。因此，BfArM 還在 DiGA 領域為數據保護設定了額外的要求 以供批准。
In particular, this significantly influences the choice of suitable server providers. Many services used by numerous apps are hosted on servers in the USA, where the level of data protection is often considered inadequate from a European perspective. Therefore, many DiGA manufacturers also opt for European alternatives in order to avoid being exposed to testing laboratories. If a US provider still offers massive advantages in your case, it is best to clarify early on whether you can also rely on one from the BfArM's point of view. We would be happy to provide you with comprehensive advice on this.
特別是，這極大地影響了選擇合適的伺服器供應商。許多應用程式使用的許多服務都託管在美國的伺服器上，從歐洲的角度來看，那裡的數據保護水準通常被認為不夠。因此，許多 DiGA 製造商也選擇歐洲替代品，以避免暴露在測試實驗室中。如果美國供應商仍然為您提供巨大的優勢，最好儘早澄清您是否也可以從 BfArM 的角度依賴美國供應商。我們很樂意為您提供這方面的全面建議。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
If possible, choose server providers who can definitely guarantee and prove compliance with the GDPR and the DiGA Regulation (DiGAV).
如果可能，請選擇絕對可以保證和證明符合 GDPR 和 DiGA 法規 （DiGAV） 的伺服器供應商。
6. Choose the right audience
6. 選擇合適的受眾
Choose a target group that will later enable you to reach as many patients as possible. Important criteria for this are:
選擇一個目標群體，以便您以後能夠接觸到盡可能多的患者。重要的標準是：
How many patients with the target indications of your DiGA are there each year? Find out the prevalence of your target indications.
每年有多少患者具有您的 DiGA 的目標適應症？瞭解目標適應症的患病率。
How digitally savvy is your target group? People with diabetes in their 20s and 30s are potentially more digitally savvy than people in their 70s and 90s with dementia. If your target group generally doesn't use apps, it will be difficult to convince them to use DiGA
您的目標群體對數字技術的瞭解程度如何？20 多歲和 30 多歲的糖尿病患者可能比 70 多歲和 90 多歲的失智患者更精通數字技術。如果您的目標群體通常不使用應用程式，則很難說服他們使用 DiGA.
Do you have existing access to the selected patient and/or doctor target group? Can you use this access to effectively increase awareness of your DiGA?
您是否擁有所選患者和/或醫生目標群體的現有訪問許可權？您能否使用此訪問許可權有效地提高對 DiGA 的認識？
What is the current care context of your target group? Is your target group already well served or are there perhaps gaps in coverage? These gaps in care could also arise, for example, from long waiting times for doctor/therapist appointments. In this case, a DiGA is probably a welcome aid for your target group.
您的目標群體目前的護理環境是什麼？您的目標群體是否已經得到了很好的服務，或者覆蓋範圍可能存在差距？例如，這些護理差距也可能是由於醫生/治療師預約的漫長等待時間而引起的。在這種情況下，DiGA 可能是您的目標群體的一個受歡迎的輔助工具。
You can also get a good market overview in the DiGA area by looking at the DiGA reports from the GKV umbrella association or the individual health insurance companies. These publish statistics, such as the number of DiGA regulations to date.
您還可以透過查看 GKV 傘式協會或個別健康保險公司的 DiGA 報告來瞭解 DiGA 領域的良好市場概況 。這些發佈統計數據，例如迄今為止的 DiGA 法規數量。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Estimate how many people you can reach with your DiGA per year. Multiply this by the planned price of your DiGA and see if the investment is promising. Also consider whether there are other patient groups that could benefit from your DiGA
估計您每年可以通過 DiGA 覆蓋多少人。將其乘以 DiGA 的計劃價格，看看投資是否有前景。還要考慮是否有其他患者群體可以從您的 DiGA 中受益.
7. Also evaluate alternative reimbursement options
7. 還要評估其他報銷選項
The DiGA Fast Track is not the only way to make money with medical device software in Germany. For example, you should also consider financing your product through a selective contract with one or more health insurance companies. There is no standardized review process for this, but the requirements and hurdles for financing may be lower. On the following page you will find a comparison with the DiGA Fast Track process.
DiGA Fast Track 並不是在德國通過醫療設備軟體賺錢的唯一途徑。例如，您還應該考慮通過與一家或多家健康保險公司的選擇性合同為您的產品融資。這沒有標準化的審查流程，但融資的要求和門檻可能更低。在以下頁面中，您將找到與 DiGA 快速通道流程的比較。
There are of course many other financing options, for example through the Central Prevention Testing Center, self-payers or B2B models with hospitals and other companies.
當然還有許多其他融資選擇，例如通過中央預防檢測中心、自費或與醫院和其他公司的 B2B 模式。
Unsere Empfehlung: Our recommendation:
UnsereEmpfehlung我們的建議：
Evaluate in advance whether the DiGA Fast Track really suits your product and your company best. There may be attractive alternatives or additions to your financing model.
提前評估 DiGA Fast Track 是否真的最適合您的產品和您的公司。您的融資模式可能有有吸引力的替代方案或補充。
Here you will find a comparison of relevant points:
在這裡，您可以找到相關點的比較：
Financing through selective contracts with health insurance companies | Financing via the Digital Supply Act |
Each health insurance company must be convinced separately | Immediate access to reimbursement from all statutory health insurance companies |
No transparent, standardized testing criteria | Standardized, transparent testing process |
The focus is usually on possible cost reductions for health insurance | The focus can be on improving human health and is initially independent of the cost savings potential for health insurance companies |
Scientific evidence usually has to be available before the reimbursement date | The potential for scientific evidence must be initially examined through an evaluation concept (and pilot study), but there does not have to be a full-scale clinical study in the first year |
No clear timeline for funding | Clear time frame through legally stipulated examination deadlines (feedback within 3 months, etc.) |
Study requirements may be lower | Very high demands on the study design |
Your application requirements may be lower | High requirements for data security, data protection, accessibility, interoperability, etc. |
Use cases are conceivable that cannot legally be approved as DiGA (e.g. primary prevention) | DiGA are limited to patient-centered applications, which are mostly used for therapy (you can read more about this in our blog article ) |
You can find out more about reimbursement for digital solutions within the framework of selective contracts in our white paper: Guide – Selective contracts for digital solutions
您可以在我們的白皮書中瞭解有關選擇性合同框架內數位解決方案報銷的更多資訊： 指南 – 數位解決方案的選擇性合同
You can find five more DiGA tips in our white paper...
您可以在我們的白皮書中找到另外五個 DiGA 技巧...
You can find all other tips about approval and certification in our DiGA white paper. Simply download using the form.
您可以在我們的 DiGA 白皮書中找到有關批准和認證的所有其他提示，只需使用表格下載即可。
Conclusion
結論
Increase the probability of success of your DiGA
提高 DiGA 的成功概率
Due to the regulatory hurdles, the development of a DiGA is not an undertaking that should be underestimated. However, with good planning and the right advice, there is a good chance that you will be admitted to the DiGA directory . We hope that the above recommendations for the approval of your DiGA will help you avoid unnecessary effort and potential risks.
由於監管 障礙， DiGA 的開發 不容小覷。但是，通過良好的計劃和正確的建議，您很有可能被 DiGA 目錄錄取 . 我們希望上述 DiGA 批准建議能説明您避免不必要的工作和潛在風險。
Further information on topics such as the DiGA approval process , proof of the positive care effect and price negotiation can also be found in our DiGA and Medical Software blog .
有關 DiGA 審批流程 、 積極護理效果 證明和 價格談判等 主題的更多資訊，也可以在我們的 DiGA 和醫療軟體博客中找到。