WO2024184740A1

WO2024184740A1 - Confidential disclosures of life sciences industries data

Info

Publication number: WO2024184740A1
Application number: PCT/IB2024/051920
Authority: WO
Inventors: Marcus Leo POSPIECH; Sebastian AURICH; Francis S. Romanski; Dominik Odenbach; Christian Becker; Cecilia IZQUIERDO SABIDO
Original assignee: BASF SE
Current assignee: BASF SE
Priority date: 2023-03-03
Filing date: 2024-02-28
Publication date: 2024-09-12
Anticipated expiration: 2025-09-03
Also published as: WO2024184737A1; WO2024184738A1

Abstract

The following relates generally to controlled disclosure of life sciences information. In some embodiments, a system applies confidentiality rules and/or privacy rules to a standardized life sciences document. The system may then construct a disclosure document based on the application of the rules. The system may subsequently determine if the disclosure document is valid (e.g. current); and, if not, construct an updated standardized document (e.g., by requesting updated standardized life sciences documents).

Description

CONFIDENTIAL DISCLOSURES OF LIFE SCIENCES INDUSTRIES DATA CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to all of: U.S. Provisional Application No. 63/461 ,707, entitled “File Creation Using Artificial Intelligence (Al), Natural Language Processing (NLP), And Other Techniques For Product, Quality And Regulatory Information The In Life Science Industries” (filed April 25, 2023); U.S. Provisional Application No. 63/461 ,689, entitled “Validation And Maintenance Of Electronic Pharmaceutical Data” (filed April 25, 2023); U.S. Provisional Application No.

63/461 ,698, entitled “Confidential Disclosures of Pharmaceutical Data” (filed April 25, 2023); U.S. Provisional Application No. 63/449,682, entitled “File Creation Using Artificial Intelligence (Al), Natural Language Processing (NLP), And Other Techniques” (filed March 3, 2023); U.S. Provisional Application No. 63/449,719, entitled “Validation And Maintenance Of Electronic Pharmaceutical Data” (filed March 3, 2023); and U.S. Provisional Application No. 63/449,704, entitled “Confidential Disclosures of Pharmaceutical Data” (filed March 3, 2023), each of which is incorporated by reference herein in their entirety.

BACKGROUND

[0002] In the pharmaceutical, biopharmaceutical, human & animal nutrition, and aroma-ingredient manufacturing and supplying industries, current systems for disclosing and sending confidential information are cumbersome, inefficient, and/or inaccurate.

[0003] The systems and methods disclosed herein provide solutions to this problem and others.

SUMMARY

[0004] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0005] In one aspect, the following discloses systems and methods for controlled disclosure of life sciences information. For example, the techniques disclosed herein may control information that is disclosed to government regulators. The disclosed techniques may control any aspects of the disclosures, such as what information to disclose to which entity. Individual files may be tagged with different confidentiality levels. Any information may also be filtered and/or redacted for privacy. The information reviewed for disclosure may be in the standardized format (e.g., a standardized life sciences format, such as a standardized pharmaceutical, biopharmaceutical, nutritional, or aroma-ingredient format), thus simplifying the process for determining what to disclose.

[0006] In one example, a computer-implemented method for controlled disclosure of life sciences information may be provided. The method may include: (1 ) receiving, via one or more processors, a standardized life sciences document; (2) receiving, via the one or more processors, confidentiality rule or privacy rule; (3) applying, via the one or more processors, the confidentiality rule or privacy rule to the standardized life sciences document; and (4) constructing, via the one or more processors, a disclosure document based on the applying the confidentiality or privacy rule to the standardized life sciences document.

[0007] In another example, a computer system for controlled disclosure of life sciences information may be provided. The computer system may include one or more processors configured to: (1 ) receive a standardized life sciences document; (2) receive confidentiality rule or privacy rule; (3) apply the confidentiality rule or privacy rule to the standardized life sciences document; and (4) construct a disclosure document based on the apply of the confidentiality or privacy rule to the standardized life sciences document.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 illustrates an example system for controlled disclosure of confidential information.

[0009] Figure 2 illustrates an example method for controlled disclosure of confidential information. [0010] Figure 3 illustrates an example standardized document with a document category of declaration.

[0011 ] Figure 4 illustrates an example standardized document with a document category of certificate, and a subcategory of certificate of analysis.

[0012] Figure 5 illustrates an example standardized document with a document category of specification.

[0013] Figure 6 depicts an example disclosure document.

[0014] Figure 7 illustrates an example method for controlled disclosure of confidential information, including determining whether to forward a standardized life sciences document.

[0015] Advantages will become more apparent to those skilled in the art from the following description of the preferred embodiments which have been shown and described by way of illustration. As will be realized, the present embodiments may be capable of other and different embodiments, and their details are capable of modification in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

DETAILED DESCRIPTION

[0016] The present embodiments relate to, inter alia, controlled disclosure of confidential information.

Example system

[0017] Figure 1 depicts an exemplary computing environment 100 in which the techniques disclosed herein may be implemented, according to some aspects. The computing environment 100 may include a disclosure computing device 102, which, in some aspects, may implement the techniques described herein. For example, the disclosure computing device 102 may construct and/or disclose a disclosure document.

[0018] The disclosure computing device 102 may include one or more processors 120, such as one or more microprocessors, controllers, and/or any other suitable type of processor. The disclosure computing device 102 may further include a memory 122 (e.g., volatile memory, non-volatile memory) accessible by the one or more processors 120, (e.g., via a memory controller). The one or more processors 120 may interact with the memory 122 to obtain and execute, for example, computer-readable instructions stored in the memory 122. Additionally or alternatively, computer-readable instructions may be stored on one or more removable media (e.g., a compact disc, a digital versatile disc, removable flash memory, etc.) that may be coupled to the disclosure computing device 102 to provide access to the computer-readable instructions stored thereon. In particular, the computer-readable instructions stored on the memory 122 may include applications, such as confidentiality or privacy rule applicator 124 and/or document constructor 126.

[0019] The confidentiality or privacy rule applicator 124 may include instructions for, inter alia, applying confidentiality or privacy rules to documents (e.g., document in a standardized life sciences format, etc.).

[0020] The confidentiality or document constructor 126 may include instructions for, inter alia, constructing disclosure documents. For example, the confidentiality or document constructor 126 may construct a disclosure document in a standardized life sciences format (e.g., a standardized pharmaceutical, biopharmaceutical, nutritional, or aroma-ingredient format) to be disclosed to a government entity (e.g., a government entity corresponding to the government computing device 160).

[0021] The internal database 1 18 may hold any suitable information. For example, the internal database 118 may hold: standardized or unstandardized life sciences documents (e.g., standardized or unstandardized pharmaceutical, biopharmaceutical, nutritional, or aroma-ingredient documents); pharmaceutical or biopharmaceutical product information; nutritional product information; aroma-ingredient information; regulatory information (e.g., information based on laws of a particular jurisdiction, etc.); compliance information (e.g., information from a company, such as a manufacturer of the product including the ingredient); information of companies (e.g. a company corresponding to the laboratory computing device 140, a company corresponding to the manufacturing computing device 150, etc.); ingredient information; confidentiality rules; privacy rules; etc. [0022] It may be noted that the regulatory information may be based on laws of a particular jurisdiction. Examples of the regulatory information include maximum amounts of ingredients in a product, information of ingredients not allowed to be mixed with each other, information of manufacturing practices, information of time periods that the ingredients are required to be current with and/or certified for, etc.

[0023] Examples of the compliance information include maximum amounts of ingredients in a product, information of ingredients not allowed to be mixed with each other, information of manufacturing practices, etc.

[0024] The external database 180 may also hold any suitable information. For example, the external database 180 may hold: standardized or unstandardized life sciences documents; pharmaceutical or biopharmaceutical product information; nutritional product information; aroma-ingredient information; regulatory information (e.g., information based on laws of a particular jurisdiction, etc.); compliance information (e.g., information from a company, such as a manufacturer of the product including the ingredient); information of companies (e.g. a company corresponding to the laboratory computing device 140, a company corresponding to the manufacturing computing device 150, etc.); ingredient information; confidentiality rules; privacy rules; etc.

[0025] The exemplary computing environment 100 may further include laboratory computing device 140, which may include one or more processors 141 , such as one or more microprocessors, controllers, and/or any other suitable type of processor. The laboratory computing device 140 may correspond to a laboratory that tests ingredients, and/or proposes ingredients for products.

[0026] The exemplary computing environment 100 may further include manufacturer computing device 150, which may include one or more processors 151 , such as one or more microprocessors, controllers, and/or any other suitable type of processor. The manufacturer computing device 150 may correspond to a manufacturer that manufactures ingredients. Additionally or alternatively, the laboratory computing device 140 may correspond to a laboratory that is inspecting a product (e.g., inspecting the product to issue a certificate for a standardized document with a category of certificate). [0027] The exemplary computing environment 100 may further include government computing device 160, which may include one or more processors 161 , such as one or more microprocessors, controllers, and/or any other suitable type of processor. In some embodiments, the government computing device 160 corresponds to a government entity or other regulator.

[0028] The exemplary computing environment 100 may further include administrator computing device 170, which may include one or more processors 171 , such as one or more microprocessors, controllers, and/or any other suitable type of processor.

[0029] The exemplary computing environment 100 may further include third party computing device 190, which may include one or more processors 191 , such as one or more microprocessors, controllers, and/or any other suitable type of processor. In some examples, the third party computing device 190 corresponds to a third party that further reviews a disclosure document before sending it to another party; for instance, the third party may be a law firm that reviews the disclosure document before sending it to the government entity or other entity.

[0030] Any of the components in the exemplary computing environment 100 may communicate via the network 104 as illustrated. The network 104 may be a single communication network, or may include multiple communication networks of one or more types (e.g., one or more wired and/or wireless local area networks (LANs), and/or one or more wired and/or wireless wide area networks (WANs), such as the Internet).

[0031] Moreover, although the example of Figure 1 illustrates only one of each of many of the components, such as the disclosure computing device 102, internal database 118, external database 180, laboratory computing device 140, manufacturer computing device 150, government computing device 160, administrator computing device 170, etc., any number of each of the components illustrated in Figure 1 may be included in a system (e.g., multiple disclosure computing devices 102, internal databases 118, external databases 180, laboratory computing devices 140, manufacturer computing devices 150, government computing devices 160, administrator computing devices 170, third party computing device 190, etc.). Example methods

[0032] Figure 2 illustrates an example method 200 for controlled disclosure of confidential information. In some embodiments, the blocks of the example method 200 may be performed by the one or more processors 120. However, although the example description below refers to blocks of the method as performed by the one or more processors 120, it should be understood that any of the blocks may be performed by any suitable component (e.g., the one or more processors 141 , the one or more processors 151 , the one or more processors 161 , the one or more processors 171 , the one or more processors 191 , etc.).

[0033] The example method 200 begins at block 210 when the one or more processors 120 receive a standardized life sciences document (e.g., a document in a standardized life sciences format, such as a pharmaceutical, biopharmaceutical, nutritional, or aroma-ingredient format). The standardized life sciences document may be received from any suitable source. For example, the standardized life sciences document may be received from the internal database 118, external database 180, laboratory computing device 140, manufacturer computing device 150, government computing device 160, administrator computing device 170, the third party computing device 190, etc.

[0034] As will be described elsewhere herein, the standardized life sciences document may have a category (e.g., specification, declaration, or certificate), and a subcategory. Advantageously, receiving the life sciences document as a standardized document (rather than an unstandardized document, such as an unstandardized email, pdf, power point, etc.) streamlines the controlled disclosure of life sciences information process. For example, the system is able to determine the information to include in the disclosure document more quickly and more accurately because the system “knows” exactly where to pull the information from rather than having to search for the information (e.g., using an NLP algorithm, etc.) or guess where the information is; that is, the systems described herein reduce the likelihood of erroneous acquisitions of information that would come from an unstandardized document. Further advantageously, a standardized document (e.g., with a category of specification, declaration, or certificate) may be created from a plurality of unstandardized documents (e.g., emails, pdf files, etc.) sent by a company. Thus, in examples where a government entity has requested that specific information be disclosed, the one or more processors 120 will have to review fewer document(s) to find the requested information than a system that reviews unstandardized documents.

[0035] In some examples, the standardized life sciences document may include a plurality of standardized life sciences (e.g., pharmaceutical, biopharmaceutical, nutrition, and/or aroma-ingredient) document elements, and the standardized life sciences document elements of the plurality of standardized life sciences document elements may include respective: element names; element types comprising (i) selection start, (ii) field, or (iii) selection end; field types; a mandatory or optional marking; and/or element values. In some examples, the elements names and/or element values indicate names of ingredients. Additionally or alternatively, the standardized life sciences document may include a document category and/or a document subcategory.

[0036] Examples of categories include a declaration (e.g., a declaration made by a company about a product), a certificate (e.g., a certification made by an outside party, such as an inspector, etc., about a product), and a specification (e.g., a document indicating product specifications).

[0037] Figure 3 illustrates a working example of a standardized life sciences document 300 with a document category of a declaration. In this example, the line 310 indicates the product ID (e.g., name of the product, product identification number, etc.). Put another way, the line 310 shows an element with an element name of product ID and an element value of “Product XYZ.”

[0038] The example standardized life sciences document 300 further includes line 320, which shows the declaration(s) being made (e.g., shows an element with an element name of declaration description; and an element value of a description of the declaration being made).

[0039] In the example of Figure 3, the declarations 320 include declaration topic 321 A; declaration body 321 B; declaration data 321 C; declaration reference 321 D; declaration comment 321 E; and declaration footnote 321 F. [0040] Line 330 shows an element with an element name of company name, and an element value of “ABC Corp.” Line 340 shows an element with an element name of Company Address, and an element value of “123 Main St.; Montpelier, VT 05601.” Line 350 shows an element with an element name of Company Email, and an element value of “Jane.Doe@ABCCorp.com.” It should be appreciated that any or all of the information from lines 310, 320, 330, 340, 350 may be taken by the one or more processors 120 from unstandardized document(s). Additionally or alternatively, the information from lines 310, 320, 330, 340, 350 may be taken from other standardized documents.

[0041] Line 360 shows an element with an element name of electronic signature, which has been signed by the company representative, Jane Doe. In some examples, to electronically sign the document, the one or more processors 120 may send a link (e.g., to the laboratory computing device 140, the manufacturer computing device 150, the government computing device 160, the administrator computing device 170, etc.; and/or present a link at the disclosure computing device 102, etc.) so that the standardized document 300 may be electronically signed. Additionally or alternatively, the standardized document 300 may be signed by any other suitable technique.

[0042] In some embodiments, the standardized life sciences document (received at block 210) may have a document category of a certificate (for example, a certificate about an ingredient that is required by applicable law) and a subcategory of: a certificate of analysis; a third-party certification of a good manufacturing practice; a third-party certification of quality management; or a third party certification of Kosher or Halal or RSPO (Round Table of Sustainable Palm Oil) compliance. And the validating may include validating the ingredient based on the document category and/or subcategory. In some examples, the certification category and/or corresponding subcategories may be used subsequently in the validation process (e.g., at block 230).

[0043] Figure 4 illustrates another working example of a standardized document 400. The example standardized document 400 has a document category of a certificate, and a subcategory of certificate of analysis. In this example, the line 410 indicates the product ID (e.g., name of the product, product identification number, etc.). Put another way, the line 410 shows an element with an element name of product ID and an element value of “Product XYZ.”

[0044] The example certificate of analysis 400 includes line 420, which shows the certification(s) being made (e.g., shows an element with an element name of certification description, and an element value of a description of the certification being made).

[0045] In some examples, the certifications include parameters, such as parameters 421 A, 421 B, 421 C, 421 D, 421 E, 421 F, 422A, 422B, 422C, 422D, 422E, 422F. For instance, the example certifications 420 include: Tested Parameter 1 - Name [text]: Water; Tested Parameter 1 - Description [text]: Humidity; Tested Parameter 1 - Dimension [Unit of measure]: g/100g; Tested Parameter 1 - Numeric Value [number]: 4.2; Tested Parameter 1 - Method of Analysis [text]: Ph.Eur. 123-XYZ-1998; Tested Parameter 1 - Comment [text]: fresh sample; Tested Parameter 2 - Name [text]: IR; Tested Parameter 2 - Description [text]: Identification; Tested Parameter 2 - Analytical test [Type of measurement]: qualitative; Tested Parameter 2 - Descriptive Value [text]: complies; Tested Parameter 2 - Method of Analysis [text]: USP (current version); and Tested Parameter 12- Comment [text]: test A.

[0046] Line 430 shows an element with an element name of certifier, and an element value of “Bob Smith.” Line 440 shows an element with an element name of Certifying Company, and an element value of “ZZZ Inspection Corp.” Line 450 shows an element with an element name of Certificate Number, and an element value of “12345.” Line 460 shows an element with an element name of Date of First Certification, and an element value of “1/1/2024.” It should be appreciated that any or all of the information from lines 410, 420, 430, 440, 450 may be taken by the one or more processors 120 from unstandardized document(s). Additionally or alternatively, the information from lines 410, 420, 430, 440, 450 may be taken from other standardized documents (e.g., document(s) sent by Bob Smith of ZZZ Inspection Corp., etc.).

[0047] Line 470 shows an element with an element name of electronic signature, which has been signed by the inspection company representative, Bob Smith. In some examples, to electronically sign the document, the one or more processors 120 may send a link to Bob Smith (e.g., send the link to the laboratory computing device 140, etc.) so that the standardized document 400 may be electronically signed. Additionally or alternatively, the standardized document 400 may be signed by any other suitable technique.

[0048] In addition, although the above has noted examples of the subcategories of certificate as being certificates of analysis, third-party certifications of a good manufacturing practice, third-party certifications of quality management, and third party certifications of Kosher compliance, other subcategories are possible as well. For instance, other example subcategories of certificates include: aflatoxins; allergens; genetically modified organisms (GMO); good manufacturing practice (GMP); manufacturing procedure; melamine; nitrosamine; and Transmissible Spongiform Encephalopathy (TSE) or Bovine Spongiform Encephalopathy (BSE). For example, in a certificate with a subcategory of aflatoxin, a third party may inspect and/or certify that a particular toxin is not present in the product, or present below a certain threshold amount. In another example, in a certificate with a subcategory of allergen, a third party may inspect and/or certify that a particular allergen is not present in the product, or present below a certain threshold amount. In yet another example, in a certificate with a subcategory of GMP, a third party may inspect and/or certify that the company is adhering to a GMP. Analogous inspections and/or certifications may be made for the other listed example subcategories.

[0049] In some embodiments, the standardized life sciences document (received at block 210) may have a document category of specification and a subcategory of product specification. Product specifications may include information on criteria, their dimensions and guaranteed levels or statements for a defined product. In some examples, for the product specification subcategory, the standardized document may have document elements with names indicating: specification data, specification parameters, test method, description, etc.

[0050] Figure 5 illustrates one working example of a standardized document 500. The example standardized document 500 has a document category of a specification. In this example, the line 510 indicates the product ID (e.g., name of the product, product identification number, etc.). Put another way, the line 510 shows an element with an element name of product ID and an element value of “Product XYZ.”

[0051] Line 520 shows an element with an element name of specification data, and an element value to be filled in with information from standardized or unstandardized documents in the creation of standardized document 500.

[0052] The specification data, in some examples, includes specification parameters, such as specification parameters 521 A, 521 B, 521 C, 521 D, 521 E, 521 F, 522A, 522B, 522C, 522D, 522E, 522F. For instance, the example specification data 520 includes: Specification Parameter 1 - Name [text]: Water; Specification Parameter 1 - Description [text]: Humidity; Specification Parameter 1 - Dimension [Unit of measure]: w% (g/100g); Specification Parameter 1 - Numeric Value [number]: NMT 5; Specification Parameter 1

- Method of Analysis [text]: Ph.Eur.; Specification Parameter 1 - Comment [text]: Karl- Fischer-Titration; Specification Parameter 2 - Name [text]: IR; Specification Parameter 2

- Description [text]: Identification; Specification Parameter 2 - Analytical test [Type of measurement]: qualitative; Specification Parameter 2 - Descriptive Value [text]: must comply; Specification Parameter 2 - Method of Analysis [text]: USP; and Specification Parameter 12- Comment [text]: test A.

[0053] Line 530 shows an element with an element name of company name, and an element value of “ABC Corp.” Line 540 shows an element with an element name of Company Address, and an element value of “123 Main St.; Montpelier, VT 05601.” Line 550 shows an element with an element name of Company Email, and an element value of It should be appreciated that any or all of the information

from lines 510, 520, 530, 540, 550 may be taken by the one or more processors 120 from the unstandardized document(s). Additionally or alternatively, the information from lines 510, 520, 530, 540, 550, 560 may be taken from other standardized document(s).

[0054] Line 560 shows an element with an element name of quality signature, which has been signed by the company representative, Jane Doe. In some examples, to electronically sign the document, the one or more processors 120 may send a link (e.g., to the laboratory computing device 140, the manufacturer computing device 150, the government computing device 160, the administrator computing device 170, etc.; and/or present a link at the disclosure computing device 102, etc.) so that the standardized document 500 may be electronically signed. Additionally or alternatively, the standardized document 500 may be signed by any other suitable technique.

[0055] It should further be appreciated that, in some examples, standardized documents with a category of declaration are made and/or signed by the manufacturer of the ingredient (e.g., via the manufacturer computing device 150); whereas, standardized documents with a category of certificate are made and/or signed by a third party (e.g., an inspector; and/or signed via the laboratory computing device 140).

[0056] In some embodiments, at block 210, the one or more processors 120 receive the standardized life sciences document as part of receiving a plurality of standardized life sciences documents (e.g., the standardized life sciences document is comprised in the plurality of standardized life sciences documents).

[0057] In some embodiments, prior to block 210, the one or more processors 120 first receive a request for disclosure of information (e.g., from the government computing device 160, etc.). In response to receiving the request for disclosure of information, the one or more processors 120 may request the standardized life sciences document (e.g., from the internal database 118, the external database 180, the memory 122, etc.); in some such examples, the one or more processors may identify the standardized life sciences document based on an element name and/or element value of the standardized life sciences document. The one or more processors 120 may then receive the standardized life sciences document in response to the request for the standardized life sciences document.

[0058] Additionally or alternatively, in some embodiments, prior to block 210, the one or more processors 120 first receive a request (e.g., from the government computing device 160, etc.) for disclosure of information of a product. In response to receiving the request for disclosure of information of the product, the one or more processors 120 may query (e.g., query the internal database 118, external database 180, memory 122, etc.) for documents corresponding to the product. In response to the querying, the one or more processors 120 may receive a plurality of standardized life sciences documents including the standardized life sciences document. In some such examples, the querying retrieves standardized life sciences documents including element names and/or element values corresponding to the product.

[0059] At block 220, the one or more processors 120 receive a confidentiality rule or privacy rule. The confidentiality rule or privacy rule may be received from any source, such as the internal database 118, external database 180, laboratory computing device 140, manufacturer computing device 150, government computing device 160, administrator computing device 170, the third party computing device 190, etc.

[0060] In some embodiments, the confidentiality rule comprises a rule to not disclose: information of a product; information of an ingredient in a product; manufacturing information; experimental results; trade secret information; information corresponding to a confidentiality level or a range of confidentiality levels; attorney/client privileged information; and/or information not otherwise publicly available.

[0061] In some embodiments, the privacy rule comprises a rule to not disclose: personal names; social security numbers; birthdays; personal identifiable information (PH); and/or personal addresses.

[0062] In some embodiments, the confidentiality rule or privacy rule comprises a rule to not disclose particular information before a certain date.

[0063] In some embodiments, the standardized life sciences document is tagged with a confidentiality level of the standardized life sciences document; and/or the confidentiality rule or privacy rule comprises a rule indicating a confidentiality level to disclose (e.g., to disclose generally, or to disclose to a particular entity). Individual elements of the standardized life sciences document may also be tagged with confidentiality levels. In some embodiments, the confidentiality rule comprises a rule not to disclose documents tagged with a particular confidentiality level or range of confidentiality levels.

[0064] At block 230, the one or more processors 120 apply the confidentiality rule or privacy rule to the standardized life sciences document. For example, the one or more processors 120 may identify elements of the standardized life sciences document to not be disclosed. For instance, the privacy rule may indicate that people’s name should not be disclosed; and the analyzing thus identifies elements of the standardized life sciences document indicating people’s names.

[0065] In embodiments where a plurality of standardized life sciences documents are received (e.g., at block 210), the one or more processors 120 may apply the confidentiality rule or the privacy rule to any or all of the received documents.

[0066] In embodiments were the standardized life sciences document (or plurality of standardized life sciences documents) are tagged with a confidentiality level, the applying the confidentiality rule may include applying: (i) a confidentiality rule indicating a confidentiality level to disclose to (ii) the confidentiality level of the standardized life sciences document to thereby determine if the standardized life sciences document should be disclosed.

[0067] At block 240, the one or more processors 120 construct a disclosure document based on the application of the confidentiality or privacy rule to the standardized life sciences document. In some embodiments, the disclosure document comprises a document in a standardized life sciences format.

[0068] Figure 6 depicts an example disclosure document 600. As discussed herein, the example disclosure document 600 may incorporate information from one or more standardized life sciences documents (e.g., received at block 210). For example, the ingredient information from any of lines 615, 620, 625, 630, 635, 640 may be taken from standardized life sciences documents. Additionally or alternatively, this information may be taken from an unstandardized life sciences document.

[0069] However, as further described herein, not all of the information from the standardized or unstandardized life science documents (e.g., received at block 210) is necessary included in the disclosure document. For example, there may be a privacy rule not to disclose personal addresses. Thus, in this example, if a standardized life sciences document included a personal address, the personal address would not be included in the disclosure document 600.

[0070] In another example, there may be a privacy rule not to disclose individual email addresses. In this example, if the standardized life sciences document is the standardized life sciences document 300 of Figure 3, the email address “Jane. Doe @ABCCorp.com” of line 350 may be replaced by a company email address (e.g.,

line 655).

[0071] In yet another example, there may be a confidentiality rule not to disclose trade secret information, and that the trade secret information includes that ingredient DDD is included in product XYZ. In this example, information (e.g., an amount and/or concentration) of ingredient DDD may not be included in the example disclosure document 600. In some examples, the disclosure document may include a statement that information of one or more ingredients has been withheld from the disclosure document due to trade secret considerations.

[0072] The example disclosure document 600 further includes line 610, which indicates the product ID (e.g., name of the product, product identification number, etc.). Put another way, the line 610 shows an element with an element name of product ID and an element value of “Product XYZ.”

[0073] The example disclosure document 600 further includes: line 615 (showing an amount of ingredient AAA), line 620 (showing a concentration of ingredient AAA), line 625 (showing an amount of ingredient BBB), line 630 (showing a concentration of ingredient BBB), line 635 (showing an amount of ingredient CCC), line 640 (showing a concentration of ingredient CCC), line 645 (showing a date of the disclosure document, e.g., a date that the disclosure document was created and/or last updated), line 650 (showing a company email), line 650 (showing a company address), line 655 (showing a company email), and line 660 (showing an electronic signature).

[0074] In embodiments where a plurality of standardized life sciences documents are received (e.g., at block 210), the one or more processors 120 may construct the disclosure document based on the application of the confidentiality or privacy rule to the respective documents of the plurality of standardized life sciences documents.

[0075] In one working example, the privacy rule (received at block 220) indicates that people’s name should not be disclosed; the analyzing (block 230) identifies elements of the standardized life sciences document indicating people’s names; and the construction (block 240) includes constructing the disclosure document without people’s names.

[0076] The disclosure document may also be updated. For example, the one or more processors 120 may: (1 ) receive an updated standardized life sciences document;

(2) upon receipt of the updated standardized life sciences document, apply the confidentiality or privacy rule to the updated standardized life sciences document; and

(3) construct an updated disclosure document based on the application of the confidentiality or privacy rule to the updated standardized life sciences document.

[0077] Additionally or alternatively, the one or more processors 120 may determine if the constructed disclosure document is valid (e.g., based on a date, such as an expiration date, indicated by an element of the standardized life sciences document, etc.). This determination may be made at periodic time intervals (e.g., once a day, once a week, once a month, once a year, etc.), or upon a request from any entity. If the constructed disclosure document is not valid, the one or more processors 120 may request an updated standardized life sciences document (e.g., from the internal database 118, external database 180, laboratory computing device 140, manufacturer computing device 150, government computing device 160, administrator computing device 170, the third party computing device 190, etc.). In response to the requesting the updated standardized life sciences document, the one or more processors 120 may receive the updated standardized life sciences document. Upon receipt of the updated standardized life sciences document, the one or more processors 120 may apply the confidentiality or privacy rule to the updated standardized life sciences document. The one or more processors 120 may then construct an updated disclosure document based on the application of the confidentiality or privacy rule to the updated standardized life sciences document.

[0078] At block 250, the one or more processors 120 may send the constructed disclosure document to the government computing device 160 or other device, such as the laboratory computing device 140, manufacturer computing device 150, administrator computing device 170, third party computing device 190, etc. The sending may be done at any time, such as at periodic time intervals (e.g., once a day, once a week, once a month, once a year, etc.), upon request (e.g., from the government computing device 160, etc.), etc.

[0079] In one example, the standardized life sciences document has been tagged with a first tag indicating that it may be disclosed to a first entity (e.g., the third party computing device 190); and the standardized life sciences document also tagged with a second tag indicating that it may not be disclosed to a second entity (e.g., the government computing device 160). In this example, the standardized life sciences document is sent to the first entity, but not the second entity.

[0080] In some embodiments, the one or more processors 120 may also cause a display device to display a representation of the constructed disclosure document. The display device may be any display device, such as a display device of any of the laboratory computing device 140, manufacturer computing device 150, government computing device 160, administrator computing device 170, the third party computing device 190, the disclosure computing device 102, etc.

[0081] Figure 7 illustrates an example method 700 for controlled disclosure of confidential information, including determining whether to forward a standardized life sciences document. In some embodiments, the blocks of the example method 700 may be performed by the one or more processors 120. However, although the example description below refers to blocks of the method as performed by the one or more processors 120, it should be understood that any of the blocks may be performed by any suitable component (e.g., the one or more processors 141 , the one or more processors 151 , the one or more processors 161 , the one or more processors 171 , the one or more processors 191 , etc.).

[0082] The example method 700 begins at block 715 when the one or more processors 120 receive a standardized life sciences document (e.g., similarly to block 210 of Figure 2). At block 720, the one or more processors 120 receive a confidentiality rule and/or privacy rule (e.g., similarly to block 220 of Figure 2). At block 725, the one or more processors 120 may apply the confidentiality rule or privacy rule to the standardized life sciences document (e.g., similarly to block 230 of Figure 2). [0083] At block 730, the one or more processors may determine if the standardized life sciences document violates the confidentiality rule or the privacy rule. For example, if the confidentiality rule and/or the privacy rule indicated (e.g., at block 725) that any of the information from the standardized life sciences document should not be disclosed, the one or more processors 120 may determine that the respective confidentiality rule and/or the privacy rule was violated by the standardized life sciences document. If the answer at block 730 is no, the one or more processors 120, may forward the standardized life sciences document 735 (e.g., to the government computing device 160, the third party computing device 190, etc.). In addition, if the confidentiality rule and/or the privacy rule comprises a rule not to disclose information before a certain date (and the confidentiality rules and/or the privacy rules are not otherwise violated), the one or more processors 120 may simply wait until the certain date before forwarding the standardized life sciences document.

[0084] However, in some alternative embodiments, if the determination at block 730 is no, the one or more processors may construct the disclosure document by setting the disclosure document to be the standardized life sciences document.

[0085] If the determination at block 730 is yes, the one or more processors 120 construct the disclosure document (e.g., similarly to block 240 of Figure 2).

[0086] At block 745, the one or more processors 120 may present the constructed disclosure document to a reviewer for approval, modification, or rejection. For example, the disclosure document may be presented to a human by presenting the disclosure document on a display device of the disclosure computing device 102, the laboratory computing device 140, the manufacturer computing device 150, the administrator computing device 170, or the third party computing device 190.

[0087] If the reviewer approves or modifies the disclosure document, the reviewer may also electronically sign the (possibly modified) disclosure document. And the one or more processors 120 may receive the electronic signature at block 750.

[0088] In response to receiving the electronic signature (or receiving an indication that the disclosure document has been approved and/or signed), the one or more processors 120 may further construct the disclosure document to include the electronic signature (e.g., append the electronic signature to the disclosure document, edit an element of the disclosure document to indicate that it has been electronically signed, etc.).

[0089] At block 755, the one or more processors 120 may send the signed disclosure document (e.g., similarly as in block 250 of Figure 2).

[0090] Further regarding the example flowcharts provided above, it should be noted that all blocks are not necessarily required to be performed. Moreover, additional blocks may be performed although they are not specifically illustrated in the example flowchart. Moreover, the exemplary signal diagrams and/or flowcharts are not mutually exclusive (e.g., block(s)/events from each example signal diagram and/or flowchart may be performed in any other signal diagram and/or flowchart). The flowcharts are illustrative, and not limiting.

Other Matters

[0091] Additionally, certain embodiments are described herein as including logic or a number of routines, subroutines, applications, or instructions. These may constitute either software (code embodied on a non-transitory, tangible machine-readable medium) or hardware. In hardware, the routines, etc., are tangible units capable of performing certain operations and may be configured or arranged in a certain manner. In example embodiments, one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein.

[0092] In various embodiments, a hardware module may be implemented mechanically or electronically. For example, a hardware module may comprise dedicated circuitry or logic that is permanently configured (e.g., as a special-purpose processor, such as a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC) to perform certain operations. A hardware module may also comprise programmable logic or circuitry (e.g., as encompassed within a general- purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations. It will be appreciated that the decision to implement a hardware module mechanically, in dedicated and permanently configured circuitry, or in temporarily configured circuitry (e.g., configured by software) may be driven by cost and time considerations.

[0093] Accordingly, the term “hardware module” should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired), or temporarily configured (e.g., programmed) to operate in a certain manner or to perform certain operations described herein. Considering embodiments in which hardware modules are temporarily configured (e.g., programmed), each of the hardware modules need not be configured or instantiated at any one instance in time. For example, where the hardware modules comprise a general-purpose processor configured using software, the general-purpose processor may be configured as respective different hardware modules at different times. Software may accordingly configure a processor, for example, to constitute a particular hardware module at one instance of time and to constitute a different hardware module at a different instance of time.

[0094] Hardware modules can provide information to, and receive information from, other hardware modules. Accordingly, the described hardware modules may be regarded as being communicatively coupled. Where multiple of such hardware modules exist contemporaneously, communications may be achieved through signal transmission (e.g., over appropriate circuits and buses) that connect the hardware modules. In embodiments in which multiple hardware modules are configured or instantiated at different times, communications between such hardware modules may be achieved, for example, through the storage and retrieval of information in memory structures to which the multiple hardware modules have access. For example, one hardware module may perform an operation and store the output of that operation in a memory device to which it is communicatively coupled. A further hardware module may then, at a later time, access the memory device to retrieve and process the stored output. Hardware modules may also initiate communications with input or output devices, and can operate on a resource (e.g., a collection of information). [0095] The various operations of example methods described herein may be performed, at least partially, by one or more processors that are temporarily configured (e.g., by software) or permanently configured to perform the relevant operations. Whether temporarily or permanently configured, such processors may constitute processor-implemented modules that operate to perform one or more operations or functions. The modules referred to herein may, in some example embodiments, comprise processor-implemented modules.

[0096] Similarly, the methods or routines described herein may be at least partially processor-implemented. For example, at least some of the operations of a method may be performed by one or more processors or processor-implemented hardware modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of geographic locations.

[0097] Furthermore, the patent claims at the end of this patent application are not intended to be construed under 35 U.S.C. § 112(f) unless traditional means-plus- function language is expressly recited, such as “means for” or “step for” language being explicitly recited in the claim(s). The systems and methods described herein are directed to an improvement to computer functionality, and improve the functioning of conventional computers.

Claims

WHAT IS CLAIMED:

1 . A computer-implemented method for controlled disclosure of life sciences information, the method comprising: receiving, via one or more processors, a standardized life sciences document; receiving, via the one or more processors, confidentiality rule or privacy rule; applying, via the one or more processors, the confidentiality rule or privacy rule to the standardized life sciences document; and constructing, via the one or more processors, a disclosure document based on the applying the confidentiality or privacy rule to the standardized life sciences document.

2. The computer-implemented method of claim 1 , further comprising: receiving, via the one or more processors, and from a government computing device, a request for disclosure of information; and in response to receiving the request for disclosure of information, requesting, via the one or more processors, the standardized life sciences document; and wherein the standardized life sciences document is received in response to the request for the standardized life sciences document.

3. The computer-implemented method of any one of claims 1 -2, further comprising: receiving, via the one or more processors, and from a government computing device, a request for disclosure of information of a product; and in response to receiving the request for disclosure of information of the product, querying, via the one or more processors, a database for documents corresponding to the product; and wherein:

(i) the standardized life sciences document corresponds to the product, and (ii) receiving the standardized life sciences document comprises receiving the standardized life sciences document: (a) in response to the querying, and (b) comprised in a plurality of standardized life sciences documents corresponding to the product; the applying the confidentiality rule or privacy rule further comprises applying the confidentiality rule or privacy rule to respective documents of the plurality of standardized life sciences documents; and the constructing the disclosure document further comprises constructing the disclosure document based on the applying the confidentiality or privacy rule to the respective documents of the plurality of standardized life sciences documents.

4. The computer-implemented method of claim 3, wherein: documents in the database are: (i) in a standardized life sciences file format, and (ii) include elements with element names and/or element values; and the querying comprises retrieving documents from the database with element names and/or element values corresponding to the product.

5. The computer-implemented method of any one of claims 1 -4, further comprising, at periodic time intervals, sending, via the one or more processors, the constructed disclosure document to a government computing device.

6. The computer-implemented method of any one of claims 1 -5, further comprising, at periodic time intervals: determining, via the one or more processors, if the constructed disclosure document is valid; if the constructed disclosure document is not valid, requesting, via the one or more processors, an updated standardized life sciences document; in response to the requesting the updated standardized life sciences document, receiving, via the one or more processors, the updated standardized life sciences document; upon receipt of the updated standardized life sciences document, applying, via the one or more processors, the confidentiality or privacy rule to the updated standardized life sciences document; and constructing, via the one or more processors, an updated disclosure document based on the applying the confidentiality or privacy rule to the updated standardized life sciences document.

7. The computer-implemented method of claim 6, wherein the determining of if the constructed disclosure document is valid comprises determining if the constructed disclosure document is valid based on a date indicated by an element of the standardized life sciences document.

8. The computer-implemented method of any one of claims 1 -7, further comprising: receiving, via the one or more processors, an updated standardized life sciences document; upon receipt of the updated standardized life sciences document, applying, via the one or more processors, the confidentiality or privacy rule to the updated standardized life sciences document; and constructing, via the one or more processors, an updated disclosure document based on the applying the confidentiality or privacy rule to the updated standardized life sciences document.

9. The computer-implemented method of any one of claims 1 -8, further comprising sending, via the one or more processors, the constructed disclosure document to a government computing device.

10. The computer-implemented method of any one of claims 1 -9, wherein the confidentiality rule or privacy rule comprises the confidentiality rule, and the confidentiality rule comprises a rule to not disclose: information of a product; trade secret information; and/or information not otherwise publicly available.

11 . The computer-implemented method of any one of claims 1 -10, wherein the confidentiality rule or privacy rule comprises the privacy rule, and the privacy rule comprises a rule to not disclose: personal names; social security numbers; birthdays; personal identifiable information (PH); and/or personal addresses.

12. The computer-implemented method of any one of claims 1 -1 1 , wherein the confidentiality rule or privacy rule comprises a rule to not disclose particular information before a certain date.

13. The computer-implemented method of any one of claims 1 -12, wherein: the standardized life sciences document is tagged with a confidentiality level of the standardized life sciences document; the confidentiality rule or privacy rule comprises a rule indicating a confidentiality level to disclose; and the applying the confidentiality rule or privacy rule comprises applying the rule indicating a confidentiality level to disclose to the confidentiality level of the standardized life sciences document to thereby determine if the standardized life sciences document should be disclosed.

14. The computer-implemented method of any one of claims 1 -13, wherein: the standardized life sciences document is tagged with a first tag indicating that it may be disclosed to a first entity; and the standardized life sciences document is tagged with a second tag indicating that it may not be disclosed to a second entity.

15. The computer-implemented method of any one of claims 1 -14, wherein: the standardized life sciences document is a first standardized life sciences document; the method further comprises: receiving, via the one or more processors, a second standardized life sciences document; and applying, via the one or more processors, the confidentiality rule or privacy rule to the second standardized life sciences document; and the constructing the disclosure document further comprises constructing the disclosure document further based on the applying the confidentiality or privacy rule to the second standardized life sciences document.

16. The computer-implemented method of any one of claims 1 -15, wherein the disclosure document comprises a document in a standardized life sciences format.

17. A computer system for controlled disclosure of life sciences information, the computer system comprising one or more processors configured to: receive a standardized life sciences document; receive confidentiality rule or privacy rule; apply the confidentiality rule or privacy rule to the standardized life sciences document; and construct a disclosure document based on the apply of the confidentiality or privacy rule to the standardized life sciences document.

18. The computer system of claim 17, further comprising a display device, and wherein the one or more processors are further configured to display a representation of the constructed disclosure document on the display device.

19. The computer system of any one of claims 17-18, wherein the standardized life sciences document comprises a standardized pharmaceutical document, a standardized biopharmaceutical document, a standardized nutritional document, or a standardized aroma-ingredient document.

20. The computer system of any one of claims 17-19, wherein the one or more processors are further configured to construct the disclosure document by: presenting a link allowing a user to electronically sign the disclosure document; receiving an indication that the user has electronically signed the disclosure document; and in response to receiving the indication that the user has electronically signed the document, constructing the disclosure document to include an electronic signature.