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Biometric-based key management for satisfying patient’s control over health information in the HIPAA regulations

According to the privacy regulations of the health insurance portability and accountability act (HIPAA), patients’ control over electronic health data is one of the major concern issues. Currently, remote access authorization is considered as the best solution to guarantee the patients’ control over their health data. In this paper, a new biometric-based key management scheme is proposed to facilitate remote access authorization anytime and anywhere. First, patients and doctors can use their biometric information to verify the authenticity of communication partners through real-time video communication technology. Second, a safety channel is provided in delivering their access authorization and secret data between patient and doctor. In the designed scheme, the user’s public key is authenticated by the corresponding biometric information without the help of public key infrastructure (PKI). Therefore, our proposed scheme does not have the costs of certificate storage, certificate delivery, and certificate revocation. In addition, the implementation time of our proposed system can be significantly reduced.


Introduction
The technology advances as the time goes. The medical data of a patient is stored in electronic form for convenience, consisting of diagnosis, treatment, and medical image. It might cause serious effect on health status if there exists an unauthorized modification. Also, the medical information includes individual strings such as name, gender, address, and ID card number. All these information are significant to a patient. Therefore, patient control over health information is one of the major concern issues in the privacy regulations of health insurance and accountability act (HIPAA) [1]. Privacy regulations provide the various rights for patients to assure that a patient can control their electronic protected health data anytime and anywhere. For examples, Guo et al. have introduced attribute-based access control for patient to manage their healthy data [2], and the authorized groups being able to read the medical record of patient are recorded in smart contract for medical research [3]. According to the description of the privacy regulations of the HIPAA, patient's health information control means that everyone, who wants to access a patient's health information, must have access permission of the patient.
To prevent unauthorized data access as well as to guaranty the confidentiality of a patient's health information, cryptographic systems [4] can be applied to encrypt the medical data. In such a way, the decrypted key must be exactly provided to legally authorized users for carrying out the activities, which predefined based on their role, job function or responsibility. In 2008, Lee et al. [5] proposed a smart card-based key management solution by integrating various cryptographic techniques to solve the above problems. Then, several methods are proposed to deal with key management concern issues [6]- [10].
The methods in [5]- [10] allow that a patient provides his/her access authorization directly to an authorized user by presenting and enabling a smart card. In this consent case, the patients can correctly control the access to their health information. However, patients sometimes cannot directly provide their access authorization to medical staff, but the patient's health information still is used or disclosed for performing certain activities such as the payment or treatment under the supervision of a third party. In this case, the patient can not completely control their health data. It severely affects the data access control and the confidentiality of a patient's medical information. To ensure the patient can monitor their health information even in the exception case, the methods in [5], [10] allow that a patient authorizes healthcare institutes to access his/her medical information within a contract time period. In addition, the method in [10] also allows that a patient is able to revoke the authorization at any time. However, the disadvantage of these methods is that the authorized users can access the patient's medical information to use and disclosure as whatever they like before the valid time period expires. Therefore, patients will lose control of their health information during the valid time period of the authorization.
Due to the extraordinary evolution of information technology in the recent decade, real-time communication has become very popular in our life, especially in the health care environment. Telemedicine [11] helps doctors remotely diagnose and treat the sickness of patients like face-to-face communication [12]. In telemedicine, doctors sometimes need the related medical information of the patients to diagnose the illness of the patients under online video communication. In order to ensure the privacy of the patient's information that was defined in the HIPAA regulations, remote access authorization from the patients to doctors becomes an urgent requirement for patients to control their health information. Unfortunately, those methods in [5]- [10] are not suitable for this case, that is authorizing healthcare institutes to access a patient's health information in telemedicine.
In this paper, we employ real-time communication technology to design new biometric-based key management scheme for achieving remote authorization in telemedicine. To make the proposed system can be work in practice, several well-established cryptographic mechanisms are applied to protect the medical data. For legally authorized users, the patient will provide the decryption key for each encryption medical record. Only authorized users have decrypted key to decrypt the emcryption medical files. Hence, patients' control over their health information is more strengthening and the patient's privacy in the HIPAA regulations to be guaranteed.
The remainder of this paper is organized as follows. Section II briefly introduces the related works to understand our design easily. In section III, the proposed method is described in details. Section IV provides privacy, security, and feasibility analyses to prove that the proposed scheme satisfies the requirements of HIPAA regulations. Finally, the conclusions and future works are listed in section V.

Related Works
In this section, we briefly introduce five related technologies, i.e., 1) RSA and unbalanced RSA cryptosystem, 2) Shamir's identity-based signature, 3) fuzzy extractor scheme, 4) Liu et al.'s real-time communication scheme, and 5) healthcare certificate authority and healthcare virtual smart card in Taiwan.

RSA and Unbalanced RSA
RSA and unbalanced RSA are public-key cryptography algorithms, which are used in encrypting a secret message. The security of RSA and unbalanced RSA is based on the difficulty of factoring large integers. Due to the key size of unbalanced RSA is bigger than that of RSA, unbalanced RSA is more robustness than RSA for resisting rapidly increasing computing power.

RSA
A public-key cryptography algorithm, called RSA scheme [4], was proposed by Ron Rivest, Adi Shamir and Leonard Adleman in 1978. This algorithm quickly become one of the most used mainstays for internet security. In the RSA scheme, a public/private key pair is easily generated when two large prime numbers are obtained. The public key can be published while the private key must be kept secretly. A secret message can be protected by using the public key, and the encrypted message can be decrypted by the correspoding private key. The RSA algorithm can be illustrated as three parts that including key generation, encryption, and decryption.

Key generation:
Two large different prime numbers p, and q, with the same length size are choosed. Then, a user computes n = p.q and

Encryption:
Assume that M is a message; it can be encrypted into ciphertext C by using a public key e as n M C e mod = .

Decryption:
The ciphertext C can be decrypted by using the correspoding private key d as

Unbalanced RSA
A variant RSA cryptosystem, called unbalanced RSA scheme [13], was proposed by Shamir in 1995. The difference between unbalanced RSA and traditional RSA is the size of two prime numbers, i.e., p and q. In traditional RSA, |p|=|q| and |p.q|=512-bits. In unbalanced RSA, |p| ≠ |q| and |p.q|=5000-bits. Therefore, the unbalanced RSA has higher security than RSA.
The key generation of the unbalanced RSA is shown as below.
1. The user computes the value t = G(i), where G(.) is a public function which is used to convert any user's identity i into a unique 5000-bits. When having the user's identity i and the public key s, anyone can recover the modulus N by computing N = G(i) + s.

Shamir's identity-based signature scheme
In 1998, Shamir proposed a signature scheme based on the RSA cryptosystem. The procedures of this signature scheme are performed as follows: A user obtains a unique number g from key generation server as , where i is the user's identification.
To sign the signature on the message m, the user chooses a random number r to compute the parameters t and s as The verification condition of the signature scheme is

Fuzzy extractor scheme
In 2008, Dodis et al. proposed a fuzzy extractor scheme to transform biometric data into a cryptographic key [14]. In this scheme, a random secret string R and a random helper string P are extracted from a biometric data w in a noise-tolerant way. If any biometric w' is similar to original biometric w, the random secret string R can be recovered exactly from it with the helper string P. The secure sketches and fuzzy extractors are constructed by using three metrics that include hamming distance, set difference, and edit distance. The fuzzy extractor has two functions: 1. Generation function Gen(.) is defined as Gen(w) = (R, P), where the input w is the biometric information, and the outputs R and P are the secret and the helper strings.

Reproduction function
The biometric w' must be sufficiently close to the original biometric w. In other words, the Hamming distance between w' and w is smaller than a threshold value.

Liu et al.'s real-time communication scheme
In 2018, Liu et al. proposed a new scheme to create a secure communication channel over a public network [15]. This scheme is divided into two-phase: the initialization phase and the authentication and key agreement phase. In the initialization phase, both communication partners will use real-time online communication to identify and confirm each other in front of the camera. An unbalanced RSA key pair is generated from their biometric without the help of public key infrastructure (PKI). They exchange some information over a public network for recovering and verifying each other's public key in the authentication and key agreement phase. Finally, a session key, which is used to protect the secret message, will be randomly generated. Interested readers may refer to [15] for more details.

Healthcare certificate authority and healthcare virtual smart card in Taiwan
In order to provide and manage public keys and certificates of all participants in the healthcare environment, Taiwan's government root certification authority (GRCA) [16] has established the healthcare certificate authority (HCA). Therefore, HCA is responsible for the management of public keys and certificates of the healthcare institutes, medical care personnel, and patients. Additionally, as the advantages of the virtual smart card such as contactless and biometric identification functions like fingerprint or iris recognition. It can increase resistance to the physical and the logical attack. Therefore, the virtual smart card is widely used to store sensitive data. In Taiwan, the virtual smart card is begun used from August 2018 in the healthcare environment [17]. It is evident that a virtual smart card, which is based on smartphone technology, can help us to accomplish some significant requirements of security and privacy issues.

Proposed Scheme
In the proposed scheme, there are three roles in the healthcare environment, i.e., users (doctors and patients), a personal health record server (PHR), and a governmental healthcare office (SG). All doctors and patients have a smart device with a camera such as a smartphone, laptop. The personal health record server (PHR) is a data center; it is responsible for storing the patient's encrypted health information record. The governmental healthcare office (SG) is a trusted server; it is responsible for managing all participants' keys. Besides, we assume that E CK (.) and D CK (.) are an encryption function and the corresponding decryption function with a symmetric key CK, and H(.) is a public one-way hash function such as SHA-256. The proposed scheme is divided into three phases: the initialization phase, the medical information package phase, and the fetch phase. Notations and the details of our proposed scheme are described in Table 1 and subsections 3.1, 3.2 and 3.3. The generator of Fuzzy Extractors Ren(.) The reputation of Fuzzy Extractors The function of symmetric encryption with a content key, CK D CK (.) A function of symmetric decryption with a content key, CK H(.) One-way hash function G(.) The public function used to convert any data into a unique 5000-bits long.

Initialization phase
To obtain services from a healthcare provider, each user first must register their biometric information at the SG server for obtaining a key pair of RSA through a virtual private network VPN. In this paper, the user's face is used as the biometric information to generate the key pair of RSA, and the procedures are performed as the following steps.
Step 1: The user captures face to produce biometric u β by using his/her camera.
Step 2: The user sends the biometric u β and the identification u id to the SG server.
Step 3: After checking the validity of data, the SG server generates extracted string id u and helper string u γ by using fuzzy extractor function Gen(.), i.e., (1) Step 4: The SG server computes a unique fixed length parameter u τ by using a random bit generator function G(.), i.e., (2) Step 5: The SG server chooses two random prime numbers ( , and α is a security attribute.
Step 6: The SG server computes a parameter u n as (3) Step 7: The SG server chooses a key pair of RSA, ) , ( u u d e [15], where  Step 8: The SG server computes a public number u N as [15]  (4) Step

Medical information package phase
For simplicity, we assume that M is the electronic health information of a patient and the data index id M refers to M. To ensure the privacy of patients, M must be encrypted. Therefore, when M is created by physicians, the patient's smartphone must be enabled by entering his/her password or verifying the biometric information to create an encryption key k M . Then, the enabled smartphone will perform the following steps to package M.
Step (5) Step 2: Generates an encryption key M k as where id p is the patient's identification.
Step 3: Creates a checksum of M as Step 4: Encrypts the patient's medical data M as (8) Step 5: Encrypts the helper string M γ as (9) Step 6: Stores

Fetch phase
In order to provide the patient's health information safely for an authorized user, this phase is divided into two sessions, i.e., 1) the authentication and authorization session 2) the decryption session. The detail of each session is described as follows

Authentication and authorization session
In this session, a patient and a doctor will have a conversation using real-time video communication. Once they confirm that their expected communication partner is correct, they will exchange their public keys and start to verify the correctness of the partner's public key by using the partner's face. After authentication each other, a session key will be generated. Authentication and authorization session are produced as the following steps. Note that the Step 3 to Step 10 are similar to [15]. health information in the HIPAA regulations Step 1: The patient sends its parameters ) , , ( Step 4: The patient computes the doctor's u τ as (11) Step 5: The patient computes the doctor's modus n d as Similarly, when the doctor performs steps 2 to 5, he also reproduces the patient's modus n p .
Step 6: The patient chooses a random number K p .
Step 7: The patient encrypts K p as (13) Step 8: The patient sends p K C to the doctor.
Step 9: When receiving p K C from the patient, The doctor decrypts Step 10: The doctor chooses a random number K d .
Step 11: The doctor computes the session key k s as Step 12: The doctor encrypts K d as (16) Step 13: The doctor encrypts the parameters (id d , id M ) as (17) Step 14: The doctor sends (s, C DI ) to the patient.
Step 15: When receiving the ( d K C , C DI ) from the doctor, the patient decrypts (18) Step 16: The patient computes session key k s as Step 17: The patient decrypts C DI as (20) Step 18: The patient generates permission of the patient as Step 19: The patient encrypts the permission per p as ) , , ( (22) Step 20: The patient sends p per C to the doctor as a patient's health information access authorization.

Decryption session
When the doctor receives the permission of the patient, he/she creates a signature on this permission for requestting the patient's health information from the PHR server. The procedures of the doctor and the PHR server are shown as follows: Step 1: The doctor decrypt Step 2: The doctor generates a signture s d as (24) Step  (26) Step 8: The enable smartphone recovers the extracting string M δ as (27) where p β ′ is the patient's biometric information.
Step 9: The enable smartphone recalls the decryption key k M as (28) Step 10: The enable smartphone encrypts k M as (29) Step 11: The enable smartphone sends M k C to the doctor.
Step 12: When receiving the decrypted data (31) Step 14: The doctor checks the validity of cs M as (32) When having the patient's health information, the doctor can use M according to the privacy regulations of the HIPAA.

Analysis
In this paper, we propose a new biometric-based key management to ensure patients' remote control over health information according to the individual privacy/security rule of HIPAA regulations. In addition, the proposed scheme also allows patients and doctors can safely exchange health information through the public network based on the advantages of real-time online video communication. To ensure the proposed scheme is secure and feasibility, we first focus on analyzing the privacy and security in subsections 4.1, 4.2, and 4.3. Second, the feasibility analysis of the proposed scheme is discussed in subsection 4.4. Finally, we give the comparisons of properties between Liu et al.'s scheme and ours in subsection 4.5.

Privacy protection issues
In this subsection, we focus on analyzing the privacy protection capability and the patient's health information access processes.
For each patient, we apply the patient's biometric information p β into Equation (1) to get the secret string M δ . Then, we apply M δ , id p , and id M into Equation (2) to get an symmetry encryption key k M , where id p is a unique identification of patient and id M is the medical record index. Finally, we employ a symmetry encryption algorithm, advanced encryption standard (AES) [18], [19], to protect the patient's health information record. Thus, the patient's health information is compromised only if the secret string M δ is broken. When each authorized user wants to decrypt the patient's encrypted medical information record C M in Equation (8), the secret string M δ must be recovered. According to Equation (27), we know that the secret key M δ is recovered from the patient's biometric information p β ′ the helper string M γ is required, Since M γ is encrypted by the public key e p of the patient in Equation (9), the encrypted medical record only can be decrypted by the patient who has the private key .

Authentication and authorization issues
Real-time online video communication allows patients and doctors to see each other through a camera lens. Therefore, it can help patients and doctors easily to identify and confirm each other as a kind of face-to-face communication. In the initialization phase, the private keys (d p , d d ) and the public keys (e p , e d ) are generated based on the users' biometrics. In the authentication and authorization session, the public keys (e p , e d ) will be verified with the focus on whether exchanged information is trustworthy between two parties. We are going to employ BAN logic to prove the correctness of the mutual authentication of our proposed scheme. We give a formal definition and rules of the BAN logic model in Table 2 [20], [21] and below. According to steps 1 to 5 of the authentication and authorization session phase, we know that only the patient and doctor compute n d and n p . Therefore, we can treat n d and n p as the secrets between patient and doctor.
To complete the analysis, we give the following basic assumption:

Feasibility analysis
In order to make sure the practicability of the proposed system, we have discussed the used techniques, equipment, and information in this subsection.

Required techniques
In our proposed system, some of the techniques are required, i.e., a one-way hash function, an asymmetric/symmetric cipher, an identification and key generator based on biometric mechanism. All of these techniques have been carefully developed, published, and evaluated by various researchers for the past decades. Moreover, these techniques are still continuously improved for better adaptation to new applications; for instance, the biometric identification mechanism and real-time communication techniques are combined to the remote healthcare business.

Required equipment
To implement our proposed system, each healthcare provider and users need to equip a network and biometric extraction equipment for communication and biometric extraction. Over the past decade, real-time online communication has become very common in our life, such as video conferencing, smart space and collaborative business [22]- [24]. In 2018, Liu et al. already use real-time communication technology and digital devices in their scheme [15]. It allows that confidential and sensitive messages are conveyed between partners through the public network. Hence, all of the equipment required to implement the system is available and practical.

Required information
In the proposed system, the encryption/decryption key of patients and doctors are generated based on their's identification and biometric information. According to the above description, the individual biometric information can be easily obtained by using a digital device with a high-quality camera. We use fuzzy extractor scheme [14] to extract the secret string p δ in Equation (1) M δ and in Equation (5) from the biometric information of a user.
Fuzzy extractor scheme was proposed in 2008, many various researchers [15], [25] has proved its effectiveness and applied it in many scenarios. Thus, the information, that is used to implement the proposed system, is effectiveness.

Comparisons of properties between Liu et al.'s scheme and ours
In this subsection, we will discuss the properties of Liu et al.'s scheme and ours. Liu et al. use the biometrics key and real-time communication technologies to construct a secure channel for exchanging secret data. According to the security analyses in their article, we know that their scheme can achieve ten properties. Since our system is based on Liu et al.'s scheme, the security of our system is the same as Liu et al.'s scheme. However, Liu et al.'s scheme cannot directly apply in telemedicine. Therefore, only our system can achieve the property of patients' control over health information. Table 3 displays the comparisons of properties between Liu et al.'s scheme and ours.  [15] Proposed scheme N Y P1: the property of resisting replay attack P2: the property of resisting masquerading server attack P3: the property of resisting user impersonation attack P4: the property of resisting DoS attack P5: the property of resisting database capture attack P6: the property of resisting smart card attack P7: the property of resisting man-in-the-middle attack P8: the property of mutual authentication P9: the property of biometric recognition error P10: the property of session key agreement P11: the property of patients' control over health information

Conclusions
In this paper, we combine biometric information and real-time communication to propose a new key management scheme for strengthening patients' control over individual health information. Real-time video communication provides that patients and doctors can mutually communicate over a public network anytime and anywhere. In the designed scheme, the user's public key is authenticated by the corresponding biometric information. The PKI and third-party certifier are not involved. Therefore, our proposed scheme has lower cost than previous PKI-based schemes. In addition, the feasibility analysis shows that the scheme can be easily and effectively implemented in the current healthcare environment.