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A Million Boluses: Discovery and Disclosure of Vulnerabilities in an Insulin Pump Julian Suleder, Dr. Dina Truxius 1 About Us Julian Suleder o Security Analyst & Researcher o ERNW Research GmbH o jsuleder@ernw.de o Twitter:


  1. A Million Boluses: Discovery and Disclosure of Vulnerabilities in an Insulin Pump Julian Suleder, Dr. Dina Truxius 1

  2. About Us Julian Suleder o Security Analyst & Researcher o ERNW Research GmbH o jsuleder@ernw.de o Twitter: @jsuleder o Dr. Dina C. Truxius o Section DI 24 - Cyber Security in o the Public Health and Financial Services Sectors Federal Office for Information o Security (BSI) dina.truxius@bsi.bund.de o 2

  3. Agenda o Medical Device Security o Testing Setup o Technical Analysis Communication Protocol o Vulnerabilities o o Impact & Temporary Measures o Disclosure 3

  4. Disclaimer o This talk focuses on security vulnerabilities identified in the DANA Diabecare RS insulin pump. o The exemplifying vulnerabilities affected the pump's proprietary, Bluetooth Low Energy (BLE)-based communication and affected patient safety. o Opinions expressed belong solely to the authors and not necessarily to the authors’ employers or organizations. o We want to thank SOOIL for participating in the project. 4

  5. Part I: Medical Device Security o What is a Medical Device? o The Environment – Medical Devices o The State of IT Security in Germany 2019 o Project ManiMed 5

  6. Medical Device Classification o In the European Economic Area directives and legal regulations classify medical products Depending on their use (primarily) o Possible harms to patients (secondary) o o Depending on the classification vendors must: Implement processes for quality/risk o management, SDL and usability for products including software Get a needed certification o 6

  7. Applies to the EU! What is a medical device? o Basically everything intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, o diagnosis, monitoring, treatment, alleviation of or compensation for o an injury or handicap, investigation, replacement or modification of the anatomy or of a o physiological process, control of conception o See: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 7

  8. The Environment – Medical Devices o Not stationary o Expensive à Lifetime++ o Use Proprietary data exchange formats o Various audiences with individual backgrounds, expectations and needs o Disrupt IT management processes o Operations is key: Essential for a patient’s life 8 Photo by Jair Lázaro on Unsplash

  9. The State of IT Security in Germany 2019 o The increasing degree of networking and distribution, coupled with society's rising acceptance of mobile applications, is now associated with an elevated level of risk of cyber attacks More smart products in the health sector o Range of medical applications covered by mobile solutions is rising o Many applications are already classified as medical devices o Cybersecurity is often not given any particular priority o o New legislation, Medical Device Regulation (MDR): Medical devices will be required to have certain cyber security properties o Operation is key: Medical functionality vs. security 9 [https://www.bsi.bund.de/SharedDocs/Downloads/DE/BSI/Publikationen/Lageberichte/Lagebericht2019.pdf?__blob=publicationFile&v=7, July 28, 2020]

  10. Project ManiMed - Manipulation of Medical Devices Initiated by the German Federal Institute for Information Security (BSI) o The project aims to: o Carry out a security analysis of selected products by security assessments o Assess the current state: No finger-pointing o Increase awareness, communicate transparently, facilitate a trustful communication o and cooperation between manufacturers, security researchers, and authorities Illustrate questions medical device vendors are facing by making devices smart o 10

  11. ManiMed: Finalization o A final report for the German population will be prepared and published in German and English o Purpose: Establish active cooperation and collaboration between all stakeholders o Increase awareness, communicate transparently, enhance/built/keep o trust, get a “feeling” for vulnerabilities o Contents: Abstract description of the different device categories and vulnerabilities o Lessons learned and current state of disclosure processes o Manufactures can decide on naming their product o o Show their cooperation and lessons learned o No finger-pointing 11

  12. ManiMed: Product Categories Implantable Pacemakers, Programmers, Home Monitoring Units Insulin Pumps Ventilators and Anesthesia Devices Infusion and Syringe Pumps Patient monitors 12

  13. Part II: Testing Setup o The Medical Device: Intended Use o Where do I get Medical Devices? o Security Assessment Methodology 13 13

  14. The Medical Device o Intended use by the manufacturer: The insulin pump is the central component of the therapy system o Can be controlled with Android and iOS apps via BLE o o Other uses: Artificial Pancreas System (APS) o #WeAreNotWaiting o There are mobile applications o compatible with this pump on GitHub Patients need to build the o system for themselves SOOIL DANA Diabecare RS insulin pump 14

  15. Where do I get medical devices? o Insulin pumps and their accessories are listed as application aids in the aid register of the German Statutory Health Insurance (GKV) Regarded as prescriptible at the expense of the GKV o Insulin pumps are not publicly sold in Germany o The manufacturer provided us with two insulin pumps J o o Other common procurement problems: Direct sales: o o Vendors do not provide private persons with medical devices o Public tenders à Heterogeneous environmental requirements Lab setup requires complex medical information systems o Do not perform device assessments in production! o 15

  16. Methods: Security Assessment o Highly specialized and individual in the device's medical use case, interfaces, technologies, and assumptions to its environment o Scope: Proprietary Communication Protocol on top of Bluetooth Low Energy (BLE) o Assessment Modules: Cryptography, Authentication & Pairing Process o o Methodology: Black-box approach without source code insight o Reverse Engineering of the communication protocol using the o manufacturer's Android and iOS applications as well as communication captures 16

  17. Part III: Technical Analysis o Communication Protocol Pairing Process o Authentication Process o 17 17

  18. Application-Layer Pairing Every communication starts with the o I����i� M�bi�e P��� A�� signaling bytes \x01\x00 followed by the insulin pump’s serial number Ad�er�i�emen� Calc�la�e D_KEY from Local_Name The pump’s response indicates that the o serial number is matching \�01\�00 <�edac�ed> Encr�p� Me��age� The second message initiated by the �i�h D_KEY o \�02\�00 OK mobile application (\x01\xD1 ) Req�e�� Pairing requests the pairing \�01\�D1 This is confirmed by the insulin pump o \�02\�D1 \�00 with the response \x02\xD1\x00 After this, the user needs to manually o Con�rm Pairing on P�mp confirm the pairing request shown on the pump’s display 18

  19. Application-Layer Pairing Every communication starts with the o signaling bytes \x01\x00 followed by the insulin pump’s serial number The pump’s response indicates that the o serial number is matching The second message initiated by the o mobile application (\x01\xD1 ) requests the pairing This is confirmed by the insulin pump o with the response \x02\xD1\x00 After this, the user needs to manually o Pairing Prompt confirm the pairing request shown on the pump’s display 19

  20. Application-Layer Pairing I������ ������ o With the manual confirmation, a ���� A�� \x02\xD2 \x38\x37 message is sent to the mobile application Con�rm Pairing on P�mp o The two bytes after the signaling bytes \0�02\0�D2 ��38��37 represent the pairing key ( P_KEY ) E��rac� P_KEY \�01\�01 o \x01\x01 requests a session key \�02\�01 ��13��08��16��15��21��25��86��1D ( S_KEY ) E��rac� S_KEY + PIN o With all three keys: \�A1\�02 à Initiate higher-privileged requests Encr�p� Messages �i�h D_KEY, \�B2\�02 ��00��F2��1C��10��27��E4... P_KEY, S_KEY 20

  21. Paired Communication In��lin M�bile P�m� A�� o After the pairing and Ad�e��i�emen� Calc�la�e D_KEY exchange of the pairing key: f��m L�cal_Name o The P_KEY is appended to \�01\�00 <�edac�ed> Enc���� Me��age� \x01\xD0 signaling bytes �i�h D_KEY \�02\�00 OK à \x01\xD0 \x38\x37 Send P_KEY \�01\�D0 \�38\�37 o The session key ( S_KEY ) is \�02\�D0 \�00 requested to finish the handshake \�01\�01 \�02\�01 \�13\�08\�16\�15\�21\�25\�86\�1D E���ac� S_KEY + PIN \�A1\�02 Enc���� Me��age� �i�h D_KEY, \�B2\�02 \�00\�F2\�1C\�10\�27\�E4... P_KEY, S_KEY 21

  22. Part IV: Technical Analysis o Vulnerabilities 22 22

  23. Weak PINs Default Device Keypad Lock PIN: 1234 Recommending Weak Device Keypad Lock PINs: Use device PINs near 0000 such as 1000 to easily disable the device lock „The PIN 0000 can be used to unlock the device easily“ Default Physician Menu PIN: 3022 Manufacturer: The PINs’ Purpose is to prevent erroneous operation of the keypad An attacker needs physical access 23

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