Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
1
Remote Physician Authentica~~ Service
Background and Summary of the Invention
The present application relates to authentication of computer users requesting
controlled information in distributed environments, and more particularly to
remote
authentication of physicians requesting controlled information across the
Internet.
Background: Pharmaceutical and Medical Device Information
Communication of professional information in the health care industries is
(quite
literally) vital, and yet there are severe problems in the legal system which
make frank
communication among physicians difficult and/or dangerous.
Background: Medical Liability
A significant problem with physician communications (especially in the United
States)
is that doctors and medical care organizations are a favorite target of
predatory lawyers. The
exposure to lawsuits is so high that liability insurance rates are a major
factor in determining
the economic viability of professional practices. Consequently, the
recommendations of
medical insurance companies may be impossible for health care professionals to
resist. In this
environment any vulnerability which makes it easier for physicians and health
care organiza-
tions to be attacked by frivolous lawsuits is extremely unwelcome. For this
reason, it is
undesirable to have physician communications with the vendors of health care
products be
open for snooping. The necessity for health care professionals to watch every
word of
communication, out of concenn for attack by frivolous lawsuits, puts a
significant damper on
a physician's ability to gain access to new medical information, or to openly
discuss case
studies with colleagues. Since foreign medical suppliers can be subjected to
U.S. liability in
some cases, this legal problem affects medical companies worldwide.
Background: Patient Confidential Information
Health care professionals are constrained in their ability to discuss and
release patient
confidential information. Such information is usually protected by doctor
patient confidentiali-
SUE3SI~iTUTE SHEET (RULE 261
CA 02346709 2001-04-06
WO 00/27088 PCTNS99/22253
z
ty because of its extremely sensitive nature. In many jurisdictions a health
care professional
may be held liable to the patient if -the health care professional allows such
information to
escape. Nevertheless, such sensitive information is often relevant to
discussions of the cases
faced by physicians. Even vvithout the patient's name attached, the complete
set of patient
data may be such as to indicate the identity of the patient and thus permit
the escape of
sensitive information to a careful snooper. Thus the physician's legal
environment is
constrained both by the need to obtain new information which may relate to the
existing cases,
and by the severe legal dangers to the physician in openly transmitting such
information.
Background: Federal Regulations
Within U.S. jurisdiction, distribution of information on pharmaceuticals and
medical
devices is potentially subject to regulation by the U.S. Food and Drug
Administration (or "The
FDA"). Currently the FDA maintains that its rules do not distinguish between
promotion
aimed at lay persons and those aimed at health care professionals. However, in
practice, the
FDA applies stricter standards to communications aimed at the lay public than
those aimed
at "learned intermediaries" such as physicians. In addition to U.S.
regulations, other non-U.S.
national regulatory agencies currently maintain bans on direct-to-consumer
advertising.
According to the World Health Organization (WHO), direct consumer promotion of
prescription drugs is illegal except in the United States and Morocco.
Background: Marketing
The pharmaceutical industry spends more than $15 billion annually marketing to
physicians in the United States. Spending on sales and marketing grows every
year by almost
10%. Additionally, the 800 member companies which make up the Health Care
Industry
Marketing Association {an association of medical device manufacturers) spend
about $13
billion a year in attempts to reach physicians with information on regulated
products.
Currently, pharmaceutical companies utilize several strategies to communicate
information about their products to physicians. One such strategy is the use
of pharmaceutical
representatives to directly contact physicians at their offices. Visits by
pharmaceutical
representatives typically cost pharmaceutical companies $125-$350 per
interaction with a
physician.
Another strategy used by pharmaceutical companies is the use of telemarketing.
This
strategy has grown to include reverse communications in which a physician is
issued an
"invitation code" (or "access code"). The code is used to access lectures
concerning the latest
treatments and protocols over the phone. Even then, each interaction by
telemarketing costs
between $10 and $50.
Finally, pharmaceutical companies resort to direct mail. However, direct mail
can still
result in a per physician cost of $10-$30 each. Furthermore, direct mail is
the least reliable
of the current strategies. It cannot be determined who is actually reached
with direct mail
advertising. This uncertainty i.s particularly true if the provider has
appointed a staff member
to read and sort mail. Even if the mail does reach its intended target, the
amount of time that
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
wo oon~oss PcTius99na2s3
3
the doctor actually spends with the information and the impact of the
information on the
doctor's decision making cannot be accurately determined.
Backg_,round: Internet Marketing
Health care reform pressures manufacturers of pharmaceuticals and medical
devices
to bring down the cost of health care. At the same time, the owners or
shareholders of such
companies create internal pressure to increase profit margins and reduce
costs. Marketing
expenditures also affect health care costs. The Internet is expected to play a
significant part
in helping to reduce these ma~~keting costs. The ten leading pharmaceuticals
companies have
had sites on the world Wide Web since 1996.
In 1997, a study by Find/SVP found that approximately 35% of all American
physicians had access to the Internet. This figure exceeded that of the
general population
which was then at 20%. Internet use among Americans continues to increase at a
rate of
about 80% per year. These figures suggest that connectivity will be the rule,
especially
among medical professionals, by the year 2000. Despite the exhibited trend. no
pharmaceuti-
cal or medical device manufacturer yet uses its World Wide Web site as an
important
marketing tool for reaching physicians.
Physician's Online (1'OL) operates a market-sponsored Web site accessible by
password. POL uses an advertising business model, producing mini-sites within
its own Web
site for each subscribing company. The result is high maintenance fees coupled
with an
absence of hands-on control of their information.
Background: The Internet
The Internet, which started in the late 1960's, is a vast computer network
consisting
of many smaller networks that span the entire globe. The Internet has grown
exponentially,
and millions of users ranging from individuals to corporations now use
permanent and dial-up
connections to use the Internfa on a daily basis worldwide. The computers or
networks of
computers connected within tlhe Internet, known as "hosts", allow public
access to databases
featuring information in nearly every field of expertise and are supported by
entities ranging
from universities and government to many commercial organizations, including
pharmaceutical
companies.
The Internet maintains an open structure in which exchanges of information are
made
cost-free without restriction. The free access format inherent to the
Internet, however,
presents difficulties for thosf: information providers requiring control over
their Internet
servers. Consider, for example, a research organization that may want to make
certain
technical information available on its Internet server to a large group of
colleagues around the
globe, but the information must be kept confidential. Without means of
identifying each
client, the organization would not be able to provide information on the
network on a
confidential or preferential ba:;is. In another situation, a company may want
to provide highly
specific service tips over its Internet server only to customers having
service contracts or
accounts.
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
4
Access control by an ;Internet server is difficult for at least two reasons.
First, when
a client sends a request for a file on a remote Internet server, that message
is routed or relayed
by a Web of computers connected through the Internet until it reaches its
destination host.
The client does not necessarily know how its message reaches the server. At
the same time,
the server makes responses vvithout ever knowing exactly who the client is or
what its IP
address is. While the server may be programmed to trace its clients, the task
of tracing is
often difficult, if not impossible. Secondly, to prevent unwanted intrusion
into private local
area networks (LAN), system administrators implement various data flow control
mechanisms,
such as Internet "firewalls", within their networks. An Internet firewall is a
software structure
which allows a user to reach the Internet while preventing intruders of the
outside world from
accessing the user's LAN.
Background: Intranets and Extranets
An intranet is a smaller version of the Internet that is limited to
connections within an
organization. Access is limited to the members of the organization, usually by
means of a
firewall. A firewall acts as a f;ateway that stems the flow of data into and
out of the intranet.
An extranet is an intranet that extends access to specific users beyond the
firewall.
For instance, a company's intranet may be accessible from remote locations
that are not
physically on the company premises. A company's catalog and product
information, but no
other company data, may be accessible to customers. Access to extranets often
requires
passing a gatekeeper of some sort that only allows access to users with
specific information
(e.g., a password).
Generally, users can interact on both intranets and extranets by means of the
same
user-friendly browsers that allow Internet access.
Background: Authentication and Identification
Two-way authentication schemes generally involve hand-shaking techniques so
that
each party may verify he or she is in communication with the desired party
regardless of each
party's location or the types of devices in use. The problem to be solved is
one in which a
user communicates with a service that wishes to learn and authenticate the
user's identity and
vice versa. To clarify the problem, there are three aspects of network
security that may be
distinguished.
Identification: the way in which a user or service is referenced.
Authentication: the way in which a user may prove his or her identity.
Authorization: a method for determining what a given user may do.
The latter two aspects apply to service providers as well as to users.
A user's identity usually consists of a user name and a realm name. A realm is
a
SUBS1~'ITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
universe of identities. CompuServe Information Serve (CIS) and America Online
(AOL)
screen names are two examples of realms. The combination of user name and
realm, typically
shown as name@realm, identifies a user. Any given service recognizes some
particular set
of identities. A realm does not have to be large either in number of users or
size of service.
5 For example, a single WWW server may have its own realm of users.
Authentication provides the ability to prove identity. When asking to do
something
for which a user's identity matters, the user may be asked for his or her
identity. The service
then usually requires the user to prove that identity. To accomplish this,
most services use
a separate character string as a password. The password is intended to be kept
confidential.
If the password given for a particular identity is correct, the user is
authenticated. Of course,
there are some methods ~of authentication which are much more strict than a
username/password regime, e.g., challenge/response type systems. However, a
password
system is generally reliable for communications in which a medium Level of
trustworthy
authentication is tolerable.
Authorization refers to the process of determining whether a given user is
allowed to
do something. For example, ~;rzay the user post a message, or use a
confidential service? It
is important to realize that authentication and authorization are distinct
processes. One relates
to proving an identity and the other relates to the properties of an identity.
A service that wishes to authenticate a user requires the user to identify
himself or
herself and to prove that he or she knows the pass-phrase. Generally, the
service prompts the
user for the pass-phrase. However, transmitting the plain text pass-phrases
through a network
compromises security because an eavesdropper may learn the pass-phrase as it
travels through
the network. X.25 networks have been compromised, and LANs, modem pools, and
"The
Internet" likewise are not suitalble for plain text pass-phrases due to the
eavesdropper problem.
Prompting for the pass-phrase. while sufficient in the past, no longer works
for extensive
world-wide networks.
Background: Sales Contacts
Salesmen play a crucial role in many areas of commerce. Economic theory may
treat
buyers' decisions as rational, but in practice buying decisions are affected
by human contact
as well as by rational considerations. (Humans are social animals by nature,
and not merely
logical processes.) Thus face-~t~-face contact with salesmen is not only a
tool for spreading
information, but also a way to oprovide the reassuring contact which is part
of normal decision-
making. This aspect of sales becomes more important in areas where the price
of each
individual purchase is large, or the cost of possible errors is high, or the
pool of qualified
buyers is subjected to exten:>ive sales pressure from competing vendors.
Marketing to
physicians meets the last two of these criteria, and sometimes meets the first
criterion as well
(for purchases of capital equipment).
The importance of human contact in the buying process is discussed in the
extensive
literature on selling; see, e.g., The Sales Bible by Jeffrey Gitomer, and the
numerous books
cited therein, all of which are hereby incorporated by reference. As these
books discuss, one
SUBS~~ITUTE SHEET !RULE 261
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
6
of the important steps in the process is simply getting a chance to establish
a friendly initial
contact with the buyer. As these books also discuss extensively, buyers often
prefer not to
be bothered, and erect various barriers to such initial contact.
In some areas of e-commerce information dissemination must be restricted (as
discussed above), and this presents a dilemma which has remained unsolved. If
buyers must
provide identification before Fretting information. they expose themselves to
aggressive sales
tactics (such as unwanted phone calls or emails). When wary buyers decline to
provide
identification, then those buyers will not receive information provided by the
seller, even
though that information would benefit both buyer and seller. This is
inefficient. The present
application discloses new ways to address this dilemma.
Remote Physician Authentication Service
The present application discloses methods and systems for remote verification
of an
end user of web page with controlled access. Users are issued a user name and
password
which can be used to access <my site which subscribes to the described
verification system.
I S In practice, a user connects to a web site which contains desired
information. When the user
attempts to enter an area (or page) of the site with controlled access the pre-
issued user name
and password are requested. lance this information is entered, the subscribing
website sends
a secure (encrypted) query to a remote password database server. The supplied
information
is checked against a verification database. A yes or no verification is sent
back to the
subscriber site. The verification can also include anonymized demographic
information such
as specialty, location, and type: of practice. The subscriber site then acts
upon the verification
received. The information entered by the user, while sent by the subscribing
site is not
accessible by the subscribing site. Thus, the site cannot create its own
database of pre-verified
users and the healthcare professional remains in control of his or her
information.
The presently preferred; embodiment also contemplates a gateway site that
allows users
to login at the gateway, and thereby gain access to direct links to limited
access areas of
subscribing sites.
The present application also discloses a method and architecture wherein
computer
users who visit a marketing-related Web site may be informed about
salespersons in the their
area without exposing themsellves to solicitations. Users are often required
to enter personal
information in order to access. certain areas of Internet Web sites. The
disclosed inventions
allow users to enter enough personal data for a marketing Web site to later
target that user
with solicitations, but prevent the Web site owner from accessing most of that
data, thus
preventing the solicitations.
Users who are registered with the privacy broker ("PVS" in the presently
preferred
embodiment) are issued passwords and usernames. PVS also keeps other personal
data on the
user in their database. When a registered user logs in through the PVS
verification system to
access limited access areas of .a subscribing Web site, and that user desires
marketing related
information, the PVS server can draw data from its information already on file
about the
registered user and send selected parts of that data (e. g., zip code, area of
specialty) to the
SUBSTITUTE SHEET (RULE 261
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
7
subscribing Web site. This information will be enough for the subscribing site
to select the
correct field sales representative to show the user on their screen, along
with contact
information relevant to that sales representative.
The disclosed inventions can also be implemented to work for users not
registered with
PVS. The user is prompted for entry of personal data which is relayed from the
marketing
related Web site server to another server (the PVS server). This second server
filters the data,
returning only enough information to the marketing-related Web site server for
that site to
select a sales representative who is likely to be encountered by the user,
depending on the
user's geographic location and area of interest or specialization. The sales
representative's
face, along with other relevant contact information, is displayed for the
user.
In an alternative embodiment, the user enters only enough data for the
marketing-
related Web site to determine the sales representative that would be most
likely to deal with
the user. That salesperson''s image appears on the user's screen, along with
information
necessary for the user to corntact the salesperson, if desired. The user need
not enter a full
address, name, or telephone number, and thus is not exposed to direct
solicitation from the
salesperson or their company.. Only general location information (e.g., zip
code, area code.
or partial phone number) is entered, possibly along with information about
areas of
specialization or other interests relevant to the selection of a sales
representative. In this
embodiment, there is no filteriing or masking of the data entered by the user.
The subscribing
Web site sees it all; there simply isn't enough of it to identify the user for
direct solicitations.
There are several advantages to the present invention. Users who are deterred
from
visiting a marketing-related 'Web site for fear of encouraging solicitations
are no longer
deterred, increasing the potential hits on the Web site. Users are also made
familiar with the
contact person at the company, and may be more likely to choose that vendor
over less
familiar ones. The user also need not fear that his or her personal data might
be sold to other
companies for solicitation.
The disclosed inventions also make sales representative information more
accessible
to remote, vacant, or hard to reach territories. Some areas encounter field
sales representatives
infrequently or not at all because the area may be on the fringes of
territories, sparsely
populated, or long distances away. Users who desire information about the
easiest sales
representative to reach can find that information.
The basic password verification process requires that the user be pre-
registered with
the verification service. Registration allows the user to be entered into a
database and assigned
an identification and passwordl. These identifiers, when supplied by the user,
are matched on
the PVS server for verification. However, a more flexible method of
verification that does not
require pre-registration can also be used, as disclosed in the present
application. A U.S.
physician who has not received a PVS username and password can complete the
Rapid
Registration Form, which prompts the physician for personal data. This
personal data is
matched against the masterfile of all U.S. physicians held by the American
Medical
Association. Correct entry of the requested personal data achieves
verification. The Rapid
Registration also allows the physician to request a PVS username and password
so that the
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCTNS99/22253
8
usual verification process, i.c:., comparison with the username and password
on the PVS
password server, can be used on later visits to PVS subscribing Web sites.
There are many advantages to the disclosed methods. They offer health care
marketers
confidence that they are in complete compliance with rules that restrict or
prohibit promoting
prescription drugs to the general public. Patient confidentiality is
maintained and the health
care professional may research specific protocols, drugs, and treatments.
Malpractice liability
under learned-intermediary tort law is reduced. The disclosed business method
also opens
direct-to-physician communication on the Web without transgressing legal
limits on direct
consumer communication.
The disclosed methods also provide a verification service to device marketers
at a price
substantially lower than the cost of creating such a utility in-house.
Registration screens,
discouraging to much potential Web site traffic, can be minimized or avoided.
Also, a
storehouse of physician information can be established, and publishers and
health care
communicators can gauge their audiences more carefully. Clinical trials
managers can
communicate with potential physician investigators with the speed and cost-
effectiveness of
the Internet and the confidence of the telephone or post. Also. medical
educators can use this
on-line medium for Continuing Medical Education.
Brief Description of the Drawinss
The disclosed embodiments of the present inventions will be described with
reference
to the accompanying drawings, which show important sample embodiments of the
invention
and which are incorporated in the specification hereof by reference, wherein:
Figure 1 depicts a bllock diagram of the architecture of the Remote
Verification
System.
Figure 2 depicts a flowchart of the method of remote verification.
Figure 3 shows a black diagram of a computer system according to the presently
preferred embodiment.
Figure 4 shows the ISAPI Application Extension Process flowchart.
Figure 5 shows the ISAPI Filter Process flowchart.
Figure 6 shows a flowchart of the Rapid Registration Process, both with and
without
a PVS registered user.
Figure 7 depicts an example "welcome" page as seen on the user's browser when
they
enter the PVS Internet site.
Figure 8 shows an example "sign in" page for PVS users.
Figure 9 shows a sample "pop-up" sales representative page, where the user's
data
allows the subscribing Web site to display the sales representative most
likely to be
encountered by the user.
Figures 10 and 11 show the how verification over the Internet can make
ordering
restricted access products easier.
Detailed Description of the Preferred Embodiments
SUBS'TtTUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99I22253
9
The numerous innovative teachings of the present application will be described
with
particular reference to the presently preferred embodiment (by way of example,
and not of
limitation).
Definitions
Following are some of the technical terms which are used in the present
application.
Additional definitions can be found in the standard technical dictionaries.
Firewall: A security feature of Internet sites which is aimed at control of
data flow.
HTML: Hypertext Markup Language. A format for information transfer made up of
standard text .as well as formatting codes which indicate how the page should
be displayed in a browser.
HTTP: Hypertext Transfer Protocol. Designed to run primarily over TCP/IP using
an
Internet setup. where a server issues the data and a client displays or
processes
it.
Hypertext: A method of linking certain text, pictures or sounds by
connections, known as
"hypertext IirLks" ("links"), to other pages within the same server or even on
other computers within the Internet.
SSL: Secure Sockets Layer. A protocol for secure and authenticated
transactions over the
Internet.
URL: Uniform Resource Locator. URL's enable a Web browser to go directly to
any file
held on any Web server.
Web: The World-Wide Web (Web) is a method of accessing information on the
Internet
which allows a user to navigate the Internet resources intuitively, without IP
addresses or other technical knowledge.
X.25: A packet switching network protocol in which many connections are made
over the
same physical link.
Remote Physician Authentication
In the presently preferred embodiment, the remote authentication system
consists of
three components. Figure 1 depicts a block diagram of the architecture of the
Remote
Verification System. The Remote Verification System acts as an Internet
notary. Its function
is to attest to the identity of incoming users to Web servers which control
access to their
information and can be positioned anywhere on the Internet.
Passwords
In the presently preferred embodiment, the system is designed to verify the
passwords
of health care professionals vrho seek entry into controlled access sites on
the Internet. The
term "health care professionals" includes not only physicians, but persons in
other regulated
or licensed occupations that rely on information concerning pharmaceuticals
and medical
devices. Such occupations include, for example, dentists. doctors of
osteopathy, pharmacists,
certain nurses, and other specialist occupations which may exist within the
laws of the U.S.
SUBS'T1TUTE SHEET IRULE 261
CA 02346709 2001-04-06
WO 00/27088 PCTNS99/22253
or other countries. Such sites can be provided by pharmaceutical companies as
a marketing
tool for new products and othf:r information, and by medical societies as a
service to members
of their organizations. A user name and password combination is distributed in
advance to
verified health care professionals. Such information can be distributed via
Internet, by mail,
~ and/or by the sales force for a subscribing health care marketing
organization. Typically this
information comes from the American Medical Association's database of all U.S.
physicians
and other public record and professional society databases.
Remote Verification S stem
In the presently preferred embodiment, the health care professional (or
"user") uses a
10 computer 102 to enter the We:b site 104 of a health care marketer or
professional education
provider across a first channE:l of communications. A Web site of this son
will typically
contain more than just health care professionals-only information. For example
the site may
contain employee rosters, hunnan resource information. etc.
The system consists of several interlocking software elements, supported by
routines
running on the password verification server. The routines, Common Gateway
Interface (or
CGI) scripts, are installed on the subscriber's server to handle password and
user-name
submission transactions and mediate the interaction with the password
verification server.
The user name and password are not needed until the user requests entry to a
"health
care professionals-only" segment of the site 104. At this point, the
subscriber's Web site 104
requests the user's user name and password. The Customer Representative
function 108 (an
executable dwelling on the subscriber's site) is responsible for collecting
the user's identifiers.
Upon receipt of the user's information, the subscriber's Web site 104 sends a
secure
query to a password verification server 106 via the Internet (or other
telecommunications link)
across a second channel of communications. The query is secured via a
proprietary encryption
?5 algorithm. Additionally, an !iSL connection can be established to enhance
securitv. The
Password Client 110 (a corrvmunications program dwelling on the subscriber's
site) is a
TCP/IP communications routine which sends the query. It establishes contact
with the
Password Verification Server 106. The query is an encrypted message containing
the
subscriber's identity (for billing and verification purposes), a reply IP
address, username and
password.
The password verification server 106 contains a communications and database
interface. It will receive the Password Client's encrypted message. Then a
password database
will be searched in order to verify the username/password pair. An encrypted
go/no-go
("thumbs up"/"thumbs down") reply is returned to the Password Client 110
across the second
communications channel. This reply can include anonymous demographic
information such
as specialty, location, and type of practice.
The Password Client l 10 at the subscriber's site 104 receives the secure
go/no-go
signal back from the password verification server 106. The subscriber's Web
site 104 admits
or rejects the user's request for access to restricted content based on the
verification signal
received.
Su9sTITUTE SHEET (RULE 281
CA 02346709 2001-04-06
WO 00/Z7088 PCT/US99/22253
Information Flow
Figure 2 depicts a flowchart of the method of remote verification. The flow of
information of the remote vs:rification system will be explained in relation
to the software
elements comprising the system. First, in the presently preferred embodiment,
a health care
professional (or "user"), using a computer, makes contact with a subscribing
pharmaceutical
or medical device manufacturer's Web site (or "subscribing site") (step 202)
across a first
communications channel. Once the user requests information from a controlled
access portion
of the subscribing site (a health care professionals-only area in the
presently preferred
embodiment) (step 204), a.n HTML script requests and collects user name and
password
information from the user (st:ep 206).
Once the log-on information is collected, a routine, "PVSCIien", prepares a
message
to send to a password verification server (step 208) across a second
communications channel.
In the presently preferred emibodiment, the message comprises the collected
user name and
password. as well as an identifier to the calling site (subscribing site) for
billing, the particular
calling page, and a time stamp. After the message is prepared, it is encrypted
using the
proprietary algorithm described below and sent to a password verification
server (step 210).
Additionally, an SSL connection can be established to enhance security. A t t
h a
password verification server, a routine, "PVServer", decrypts the message and
verifies the user
name and password received (step 212). In order to decrypt the information,
the routine
matches the encryption key vvith the calling site. Once decrypted, the routine
looks up the
user's record in a verificatiion database. The user record, in the presently
preferred
embodiment, includes: user name, password, specialty code, zip code, type of
practice code,
and medical education number.
Once verification has taken place, PVServer prepares a response to send to the
subscribing site (step 214) across the second communications channel. This
message includes:
user name, password, specialty code. zip code, type of practice. and an
indication of whether
the user is accepted or rejected. The message can also include a short text
communication,
for example, contact information for users having password problems. Such
messages can be
tailored to specialty or geography. PVServer then encrypts and sends the
response to the
subscribing site in a secure nnanner (step 216). The response is secured via a
proprietary
encryption algorithm. Additionally, an SSL connection can be established to
enhance security.
At the subscribing site, PVSCIien receives the response and decrypts it (step
218).
Another routine, "drugs 1 ", executing at the subscribing site is responsible
for: welcoming or
rejecting the user based on the indication and passing demographic information
such as
specialty, zip, type of practice: and ME number to subscribing site (step
220).
Figure 7 shows an ex~~rnple of a "Welcome" page. This page welcomes the user
and
states what PVS has listed a.s the user's zip code and specialty. There are
several links
provided to the user. The user may update the PVS files kept on the user,
visit the American
Medical Association's site, or connect directly to several pharmaceutical
company sites.
Figure 8 is a sample "Sign-in" page. Users who are already registered with PVS
and
have a password and usernamE: may use this page to sign in and gain access to
limited access
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
12
areas of pharmaceutical Web sites, and to other PVS "physician only" services.
In this
example, a demonstration username "mccormickdk0l " has been entered in the
"username"
field. The "password" field shows that a password has been entered as well
(represented by
asterisks). The user then clicks the "submit" button shown below these two
fields, and the
username and password will undergo verification. If the identifiers entered
match those on the
PVS server list of registered users, the user is verified.
Figure 9 shows an example of the "pop-up" sales representative page. In this
demonstration, the user sees the SmithKline Beecham products and services
page, which
gives information about pediatric pharmaceutical products. The image of a
person is shown,
along with contact information. In actual practice, this would be a real
SmithKline Beecham
field representative whom thE: user could contact. There is also information
about products,
with links to full information about each product.
Rapid Registration
In the presently prefen~ed embodiment, the user (a health care professional
with certain
I S personal data recorded on the .American Medical Association masterfile)
wishes to enter the
secured area of a subscribing Web site. The user may enter the PVS password
and username
if the user is registered with PVS. However, some health professionals are not
registered with
PVS, and will consequently not be able to enter the required identifiers. In
this case, the user
wilt be required to complete the Rapid Registration Form which is reached
through a
hyperlink.
The Rapid Registration Form requests the users first name, last name, middle
initial,
year of graduation from medical school, state or country of medical school,
date of birth (two
digit day, two digit month, four digit year), current zip code for main
mailing address, and
email address. The user will also have the option of registering with
Physician Verification
Services, and having a username and password sent to the user. This will allow
the user to
register by entering only these identifiers, rather than the above mentioned
information.
Figure 6 shows a flov~rchart of the verification process. In step 602, the
user enters a
Web site that has limited access areas which require verification of the
user's status in order
for the user to enter. The user sees both a rapid registration and a
registered user option. If
the user has preregistered with PVS and already has a PVS password and
username, the user
enters these identifiers (step 604). The Web site server sends this data to
the PVS server (step
606), which checks the data for a match on the PVS registered user lists (step
608). The PVS
server then returns a verification of the user's status to the Web site (step
610). If the
identifiers match, PVS returns a "yes" verification and the user is admitted
to the limited
access area (step 612).
If the identifiers entered by the user do not match the PVS registered user
list, PVS
returns a "no" to the Web site (step 614). If a "no" verification is returned,
or if the user
otherwise is not registered with PVS, the user may use Rapid Registration
(step 618). At this
time, the user will also be given the option to register with PVS to obtain a
username and
password for future use (step G~20). At the Rapid Registration Form page, the
user is prompted
SUBS'InTUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99I22253
13
to enter identifying data. including name, year of graduation from medical
school, name of
the medical school where the; user graduated, date of birth, zip code, and
email address (step
622). The Web site server sends this data to the PVS server for verification
(step 624). The
PVS server checks the requested identifiers against the American Medical
Association's
S (AMA's) masterfile (step 62Ei), which is updated periodically on the PVS
server. PVS returns
a "yes" or "no" verification (step 628). If the data matches that in the AMA
masterfile, PVS
returns a "yes" verification and the user is admitted to the limited access
area (step 612). If
the data does not match, PV~S returns a "no" verification and the user is not
admitted to the
limited access area (step 630).,
Encryption Algorithm
In the presently preferred embodiment, the encryption algorithm is based on
the
mathematical principle that:
for any prime P, NP ~rtou P = N ; for all N < P
Based on that result, it can also be shown that
1 S NP'' Mon P = 1
Np~~ Mon P = 1/N
In the presently preferred embodiment, values of P and N are selected to be in
the
range of 31 to 32 bits in length. Encryption of a message comprises taking
three bytes of
clear text and appending a fourth byte of random number. A third 32-bit value,
A is added
to that result and then the entire result is multiplied by N. The result of
the multiplication
step is then divided by P. T:he remainder of the division constitutes the
encrypted message
which will be transmitted over the Internet.
During decryption, thc~ encrypted number is multiplied by 1/N and then divided
by P.
The value, A, is then subtracted from the remainder. The randomly-generated
portions of the
result are discarded. The result is the original clear text.
The above method of encryption offers both speed and efficiency. The
encryption
sends four bytes of encryptea~ data for every three bytes of plain text.
Therefore, there is a
relatively smaller (33%) increase in communication volume. Further, encryption
and
decryption utilize simple mathematical operations allowing for quick
processing times.
Preferred Embodiment for Some Operating Systems
The routines which handle password and user-name submission transactions and
mediate the interaction with the password verification server are described
above as being
implemented with CGI scripts.. However, the routines can also be implemented
with Internet
Server Applications (ISAs) and Filters provided by an Internet Server
Application
Programming Interface. An TSA is a dynamic-link library (DLL), that is, one or
more
functions that are compiled, linked, and stored separately from the processes
that utilize them.
Filters sit between the client and a server and allow special actions to take
place. While both
CGI scripts and ISAs (and Filters) can perform many of the same services (and
all of the
same services for the purpose of this application), ISAs and Filters offer
certain advantages.
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/2?088 PtyTYUS99/22253
14
The biggest advantage is that an ISA can execute in the same address space as
the process that
utilizes it. CGI scripts execute as separate processes and therefore require
environmental
variables to be passed between processes in order for communication to take
place.
Additionally, since the calling process is aware of the ISA in memory it can
purge the ISA
if it is no longer needed (or has not been called recently) and can preload it
for faster
execution when called. Any operating systems which supports loadable shared
images, such
as Windows NTTM for example, can utilize ISAs and Filters.
Detail of a Sample Preferred Embodiment
Following is a detailed description of the processes and performance of the
PVS1
ISAPI Application Extension and PVS 1 ISAPI Filter.
The PVSI ISAPI Application Extension
The PVS I ISAPI ApFdication Extension is the first element in the verification
chain
offered by Physician Verificatian Services (PVS) on Web servers utilizing
Microsoft Windows
NT and the Microsoft Internet Information Server (IIS). Specifically, this
program lives on
a Web server where there is information that needs to be protected, for
example, the Web
server of a pharmaceutical company.
In the sample embodiiment, the PVSI ISAPI Application Extension resides in the
PVS I.DLL file. Because it is, an executable, it is found in a folder that
must be flagged as
executable by the IIS. This e~;ecutable code is fired off when, for example, a
doctor seeking
protected information arrives at the gateway HTML page and fills in the
UserName and
Password fields of a form and clicks the Submit button.
For example, in a sample structure, the gateway HTML page is found at
C:\InetPublwwwrootlpvsl\pas~sword.htm. The executable, in the set of sample
files, is found
at C:lInetPub\wwwroot\pvsl\fVSI.DLL.
It should be noted that the directory structure here is just an example. It
actually can
be any arbitrary setup, provided that all of the references and pointers
remain consistent.
The PVS1 ISAPI is invoked after the PVS gateway password HTML page is shown
to a person browsing for protected information. The person first enters his or
her UserName
and Password in the appropriate fields. When the Submit button is pressed, the
PVS1.DLL
ISAPI Application Extension is fired off, and the user-supplied data is passed
to the
PVS1.DLL.
The PVSI ISAPI Application extension first checks to see that neither of the
UserName or Password fields are empty. If either is empty, the user is shown
an error
message. Otherwise, the application extension sends the password verification
request off to
the PVS password server. In order to do this, it needs some additional
information, which it
gets from a file location hardvvired into the PVSI.DLL program. In the sample
embodiment,
that file location is C:\PvsClient\pvsl.ini. That folder and that file name
must exist on drive
C: for the program to work properly. The contents of the initialization file
will be described
later.
SUBSTITUTE SHEET fRULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
Based on the responsE: from the server, the Application Extension displays
either an
error or a welcome message. Both of those are derived from HTML templates,
which wilt
be described below. Appropriate entries are made in a log ftle, also to be
described below.
If the user has given a correct UserName/Password pair, that user will be
issued an HTTP
5 cookie, which will allow the server to identify the user during subsequent
HTML requests.
The PVS-issued cookie is valid for four hours. HTML requests for protected
information from that computer will be honored during that time period. Any
subsequent
requests will result in the use:r's browser being directed once again to the
password page.
The server's behavior when a user attempts to access a protected site is
governed by
10 the other part of the PVS1.DLL program: The PVS1 ISAPI Filter.
The PVS 1 ISAPI Filter
The filter portion of the software is a part of the PVS1.DLL which gets loaded
at the
same time as Internet Infornnation Server. As its name suggests, the PVS1
ISAPI Filter
examines every HTML request that passes through the IIS WWW server. If any URL
maps
15 to a folder that has the string; "\PRI" in its path name, the PVS1 ISAPI
Filter regards the
information contained in that :folder to be protected. If the URL mapping
doesn't contain that
string, the filter takes no action at all.
If the folder does cont<~in "\PRI" (incidentally, the test for "\PRI" is not
case-sensitive)
then the filter checks to see if there is a valid PVS-issued cookie in the
HTML request
headers. If not, then the user's browser is shown an HTML file named
NotYet.htm in the
folder immediately above the "\PRI" folder in the directory tree.
If there is a valid cookie, the filter next checks to see if the user's
Authorization Bits
(which came from the server and were stored in the cookie) match the
authorization bits of
the protected folder.
A folder's authorization bits are appended to the folder's name in a
hexadecimal
scheme. The hexadecimal decoding starts immediately after the "\PRI". Hyphens
are ignored
and can be used to make the code more readable; any other character terminates
the string.
A folder with no authorization bit code string can be accessed by any verified
user.
If the user's Authorization Bits do not match the string appended to the
folder name,
the user is presented with the )-iTML page NotAuthorized.htm in the folder
immediately above
the "1PRI" folder in the directory tree.
Finally, if the validated user's authorization bits match the folder's, then
the user is
presented with the HTML page that was originally requested.
The "cookie iar"
Every time the PVS1 I:SAPI Filter allows access to a protected file based on
the user
having a valid cookie and matching authorization bits, it makes an entry in
what we call the
cookie jar. The cookie jar maintains a list of the most recent UserNames to
access protected
files, and how many hits there: were. Periodically the filter empties the
cookie jar, sending a
notification off to the PVS server that it did so.
SUBS'T1TUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
16
Password verification requests, the responses from the PVS server, and cookie
jar
dump are all logged in a PVS log file on the client server. The log file is
described below.
Contents of the PVS1.INI File
As mentioned earlier,, the PVS1 ISAPI Application Extension and the PVS1 ISAPI
Filter need some site-dependent information in order to function. Rather than
build such
information into the software, it is kept in an initialization file.
Here is a sample C:\PVSCL1:ENT\PVS1.INI file:
(pvs 1 ]
SiteID="TestSite"
PasswordServer="demosthenes.verifies.com"
TemplateRoot="c:\inetpub\vv~wwroot\pvs 1 \cgi-bin"
LogRoot="c:lpvsclient"
ServerTimeout=5000
Here is what each line means:
* [pvs 1 ] - Bookkeeping for the system routines which extract information
from the file.
* SiteID - This is your site's, identifier, so that PVS can figure out where
the request came
from. PVS will issue this code, and it should not be altered.
* PasswordServer - This is the name of the computer that processes
verification requests.
* TemplateRoot - There are a number of different possible responses that the
PVS1.DLL
program can generate. Those responses are derived from HTML templates and the
template
root tells the PVS1.DLL program where to find those templates. You will
probably alter this
to match your own Web page directory structure. This can be altered to match a
particular
web page directory structure.
* LogRoot - the PVS l .DLL, program generates a log of its activity. That log
has some
information which might be useful to you, and it too will be discussed later.
The LogRoot
specifies the folder where the: log files are to be stored.
* ServerTimeout - the number of milliseconds the program waits for a response
from the
server before resending the request. After four resends it gives up and tells
the browser that
there was no response. Setting the timeout to 5000 means that the browser will
get an error
response after twenty seconds.
Information Found in the Log Files.
In the sample embodiment, the log files are maintained in the folder c-log.txt
in the
folder specified by the LogRoot entry of the c:\pvsclientlpvsl.ini file. The c-
log.txt file is only
allowed to grow to be 1,000,000 bytes in length, at which point it is renamed
c-logl.txt. At
that same time, any file already named c-logl.txt replaces any file already
named c-log2.txt.
In this fashion, between two and three million bytes of history are
maintained, but in a way
that doesn't just keep growing forever.
SUBS'faTUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
17
The information in the log files is kept for two reasons. First, it will help
in tracking
down problems, should there be any. Second, the information is available to
the site
administrators for review and analysis.
The log file contains a handful of different possible entries. Each line
contains a
number of different fields, which are identified by number and separated by
<tab> characters.
The table of numeric codes (not all of which will be seen in any one c-log.txt
entry) is this:
PVS Parameter Values
1: TIMESTAMP: YYYYMMDDHHMMSS.SSS UTC
2: VERSION: Version code of client software
3: USER ID: The UserName:
4: PASSWORD_QUERY: Outgoing password
5: PASSWORD_OK: Response from server
6: PASSWORD NG: Response from server
7: PHARM,SITE: Site code from the PVS1.INI file
8: SERVER NAME: Computer name of the client server
9: REMOTE~HOST: As reported by the HTTP headers
10: REMOTE ADDRESS: A,s reported by the HTTP headers
11: TABLE: Indicates in which PVS table a UserName was found
13: COUNTRY: From the UserName's address
14: ZIPCODE: From the Use;rName's address
15: SPECIALTY: UserName's AMA self designated medical specialty*
16: TOP: UserName's AMA type of practice*
18: CITY: Frorn the UserNarne's address
19: STATE: From the UserName's address
20: SYSTEMMESSAGE: HTML text string from the PVS Server
21: COOKIE JAR: A cookie jar dump
22: FLAGS: Flags from client to PVS server (not yet implemented)
23: TIMEOUT: Indicates that the server didn't respond to a password request
24: MPA: UserName's AMA Major Professional Activity*
25: PRIMARYPE: UserNames AMA Primary Employment*
26: AUTHORIZATIONBITS: Username's Authorization Bits
*These are standard codes used by the American Medical Association in its
Physician
Masterfile. PVS provides interpretive tables where required.
A very typical one is the Password Request entry:
1=19990505210552.972 2=1 :3=davisr0l 4=******* 22=0 7=TestSite
8=xanadu.verifies.com
9=10.149.10.100 10=10.149.10.100.
This line is interpreted as follows: It means that at 1999-May-5 at
21:05:52.972 Universal
Time a password request was initiated by software version 1. It indicates that
* the username is "davisr0l ",
* this is a password verification request,
* the flags for this transaction are 0,
SUBS'nTUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
18
* the SiteID from the pvsl.ini file is "TestSite",
* the server's name is "xanadu.veries.com",
* the remote browser's host name is "10.149.10.100"
* and the remote browser's 1CI' address is "10.149.10.100".
There are a several possible responses which could follow this request entry
in the log. If the
PVS server is not responding, the response will be repeated three additional
times, and will
then be followed by
1=19990505212552.474 23--TIMEOUT
If the PVS password server doesn't recognize the UserName or the Password the
response
would look something like this:
1=19990505210553.457 3=d;avisr0l 6=NG
If the PVS password server does recognize the UserName and password, the
response is more
extensive:
1=19990505210553.457 3-= davisr0l 5=OK 11=1 13=USA 14=35401 15=GP 16=020
18=TUSCALOOSA 19=AL 24=OFF 25=01I 26=1
The decode of this entry:
At 1999-May-05 at 21:05:53.457 UTC this response for UserName "davisr0l" was
received.
It indicates that
* the UserName was found in PVS Table 1 (which is the AMA data file),
* the country is "USA",
* the ZIP code is "35401 ",
* the AMA specialty is "GP",
* the AMA Type of Practice is "020",
* the City is "TUSCALOOS,A.",
* the state is "AL",
* the AMA Major Professional Activity is "OFF",
* the AMA Primary Employment is "011"
* and the PVS Authorization Bits for this user are "1 ".
Another possibility for a c~lo~g entry is a dump of the cookie jar. Such an
entry would look
like this:
1=19990505211017.002 2=1 7=TestSite 8=xanadu.verifies.com 21=davisr01,3;
As before, this entry identifies the time, the software level, and the
location. (Perhaps it
should be emphasized that on any one server, the "7=" and "8=" entries will
always be the
same. But this is a copy of the information being sent to the PVS Password
server, and those
fields serve to identify where the information is coming from.) The "21="
entry consists of
UserName/count pairs separated by semicolons. This entry indicates that since
the last cookie
jar dump, UserName "davisr0l" accessed three protected pages.
PVS HTML TemplatEa
In the sample embodument. there are a number of HTML files which need to exist
or
be generated in order for the verification process to be accomplished.
SUBSTITUTE SHEET tRULE 261
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
19
The PASSWORD.HTM file: This file doesn't have to have any particular name. It
can be
found in any number of places in a Web site's structure (provided that they
are not "1PRI"
locations), and, indeed, doesn't have to have any particular form except that
the data foam
must match the one on the PVS sample. Its purpose is to invoke the PVS1 ISAPI
Application
Extension and generate a request to the PVS Password Server.
\TemplateRoot\needpw.htm: As its name suggests, this file must be found in the
TemplateRoot
specified in the C:\PVSCLIElVTIPVSI.INI file. This page gets displayed by the
PVS1 ISAPI
Application Extension when either the UserID or the UserID2 fields from the
PASS-
WORD.HTM page are empt3r when the Submit button is clicked.
\TemplateRoot\timeout.htm: 'This page is displayed to the user when the HTML
server is
unable to get a response frc>rn the PVS Password Server. The PVSI ISAPI
Application
Extension will try four times at intervals specified by the ServerTimeout
parameter in the
PVS 1.INI file.
lTemplateRootlpwnog_ood htm: This page is displayed to the user when the PVS
Password
Server sends back a "Not Verified" response.
\TemplateRootlpwokav.htm: This page is displayed to the user when the PVS
Password Server
sends back a "Username/Password verified" response.
\path\NotYet.htm: There can be any number of NotYet.htm files; there must be
one in each
folder that has a subfolder named "\PRI". The \path\NotYet.htm file is
displayed when an
unverified user attempts to access a Web page stored in a folder below
lpathlpri\.
\pathlNotAuthorized.htm: Similar to the \path\NotYet.htm file, this one is
displayed when a
verified user attempts to access a "\PRI-xx" folder when the user doesn't have
an Authoriza-
tion Bit which matches the hexadecimal "-xx" code of the folder. There must be
one such
NotAuthorized.htm file in each folder immediately above each \path\pri-xx1
folder.
HTML Template Customization
Each site can put whatever HTML information might be desired into the various
template HTML files. The PVS template files can be modified slightly based on
the
information that comes back from the PVS Password Server.
The modification is based on replacing a particular unusual text siring
("!=DUBNER")
in the HTML template files with the numerically-coded response data from the
PVS Password
Server. As a specific example, the pwokay.htm file might contain the following
HTML text
string:
The password entered with User ID !=DUBNER3 was determined to be correct. You
are located in !=DUBNER18, !=DUBNER19 DUBNER14. The system message for today
is
!=DUBNER20.
The actual text that would be generated and seen by the user would have the
various
!=DUBNER fields replaced b:y their numerical equivalents as reported by the
PVS Password
Server, specifically, they would be replaced by the UserName, the City, State,
and ZIP code,
and the system message.
SU8ST1TUTE SHEET (RULE 261
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
Having described the; system in that detail, it might be useful to summarize
it
graphically;
When a user clicks "Submit" on the password page, it starts the PVS1 ISAPI
Application Extension: Please refer to Figure 4, the PVS1 ISAPI Application
Extension
5 Flowchart.
Meanwhile, the PVSI. ISAPI Filter is checking every URL request that the
server
receives, as shown in Figure 5.
While following these: flowcharts, it should be kept in mind that many events
are
controlled by information found in the C:\PVSCLIENT\PVS1.INI initialization
file, and that
10 many of the events are logged in the \LOG;ROOT\C-LOG.TXT file as they
occur.
Figure 4 begins with 'the user submitting a username and a password (step
402). The
application extension checks for missing identifiers (step 404). Missing
identifiers prompt an
error message display (step 406). Otherwise, the request is sent to the PVS
Server (step 408}.
If a response is not returned in the allotted time (step 410) then the timeout
is logged (step
I S 412) and displayed (step 414). If the response is timely, it is checked
for a match in the
database (step 416). A non-match will return a "no good" display (steps 418
and 420). If the
response is OK'd, a PVS cookie is issued to the user (step 422) and an
acceptance message
is displayed (step 424).
Figure S shows the PVS1 ISAPI Filter Process. First the URL request is checked
(step
20 502). If it is time to dump the cookie jar (step 504) then a new process to
send a cookie jar
to the PVS Server is spawned (step 506). If it is not time to dump the cookie
jar, the URL
is checked for a "\PRI" string (step 508). If not, then the Web page is
processed normally
(step 510). If so, the user is checked for a valid cookie (step 512). If the
user has no valid
cookie, the filter displays the \PathlNotYet.html (step 5I4). If the user
still has a valid cookie,
then the filter checks the \Pri for -xx authorization suffix {step 516). If
there is a suffix. then
the user's cookie bits are checked against the \Pri-xx bits (step 518). If
they do not match.
then a non-authorization page is displayed (step 520). If they do match, then
the username is
accumulated in the cookie jar (step 522). The Web server is then allowed to
process the
requested page (step 524).
System Context
Figure 3 shows a block diagram of a computer system 300 which can be used for
implementation of a client o:r server used in the presently preferred
embodiment. In this
example, the computer system includes: user input devices (e.g. keyboard 335
and mouse
340); at least one microprocessor 325 which is operatively connected to
receive inputs from
said input device, through an interface manager chip 330 (which also provides
an interface
to the various ports); a power supply 305 which is connected to draw power
from AC mains
and provide DC voltage to the computer system 300 components; a memory (e.g.
flash or
non-volatile memory 355 and RAM 360), which is accessible by the
microprocessor; a data
output device (e.g. display 3'.50 and video display adapter card 345) which is
connected to
output data generated by microprocessor; and a magnetic disk drive 370 which
is read-write
SUBSTITUTE SHEET (RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
21
accessible, through an interface unit 365, by the microprocessor. In the
presently preferred
embodiment, the routines described which execute the method reside in RAM 360
and are
executed by the microprocessor 325.
Optionally, of course, many other components can be included, and this
configuration
is not definitive by any means. For example, the computer may also include a
CD-ROM
drive 380 and floppy disk drive ("FDD") 375 which may interface to the disk
interface
controller 365. Additionally, >r2 cache 385 may be added to speed data access
from the disk
drives to the microprocessor, and a PCMCIA 390 slot accommodates peripheral
enhancements.
Alternative Embodiment
In addition to verification services, the password verification server 106 and
the
Password Client 110 can be configured to be in constant communication. Such
communica-
tion will allow messages other than short text messages to be displayed to
health care
professionals. For instance. 'the system can operate as a rapid-notification
service for users.
passing messages of particul~~r importance to a particular user once it is
known that the user
is connected with a particular subscribing site.
Alternative Embodiment
In an alternative embodiment, the function of the verification services
described can
be extended to digital signature-like verifications. For example, prescription
orders can be
delivered on-line to mail order or local pharmacies. The use of such a
verification and
delivery service would help to eliminate the need for both a paper
prescription, which can be
forged or lost, and faxing bet~a~een a physician's office and a pharmacy. In
addition, the time
for a delivery of a mail-order prescription can be reduced due to the
immediate delivery of
the prescription authorization to the mail-order pharmacy via the Internet.
Figures 10 depict the present process of physician-initiated sampling. The
physician
requests a sample requiring verification of the physicians identity and status
as a licensed
physician (step 1002). The sample is to be sent to the physician (step 1004)
or to a patient
(step 1006). If sent to the physician, it is to be sent either by the
physician's field sales
representative (step 1008) or by courier (step 1010). Patient deliveries are
by courier (step
1012) in this model. If sent by sales representative to the physician, an
automated business
reply card (BRC) is used (step 1014). This is a system that produces an
electronic form with
fields for the physician's information needed by the pharmacy. The BRC is
returned to the
pharmaceutical company for action by the field sales force representative
(step 1020), who
does the actual distribution of the sample.
If the sample is to be sent to the physician or patient via courier, then an
online form
with faxed signature is used. An online form with the relevant physician's
information (step
1016) or with the physician's and the patient's information {step 1018) is
sent directly to a
sample fulfillment house (a pharmaceutical company or an agent of one), who
distributes the
samples to the doctor (step 1022) or the patient (step 1024). The online form
has fields for
the physician's (or the physiciian's and patient's) information like the BRC,
but also generates
SUBSTITUTE SHEET fRULE 261
CA 02346709 2001-04-06
WO 00/27088 PCT/US99/22253
22
a form for the doctor's signature to be returned to the pharmacy by fax. The
physician fills
in the relevant fields of the electronic form, which creates a suspense file
at the fulfillment
house, awaiting a faxed signature by the doctor. Once complete with signature,
the samples
are sent.
In many jurisdiction:>, an actual signature is required for the legal ordering
of
prescription drugs. The presently disclosed embodiment of the invention
creates an alternative
to this method of verification by substituting an "e-signature" for the online
form and faxed
signature. Figure 11 shows ttue same process for physician-initiated sampling,
but steps 1016
and 1018 are replaced by steps 1102 and 1104--using e-signatures instead of
faxed signatures.
The presently disclosed embodiment of the invention, by verifying the identity
and status of
a computer user as a physici2uY, obviates the need for a faxed signature.
Though presently this would not fulfill any legal requirements for an actual
signature,
it would fulfill proposed rules for electronic signatures proposed in the
Federal Register,
Wednesday, August 12, 1998, p. 43241, "Department of Health and Human
Services, Office
of the Secretary, 45 CFR part 142. Security and e-signature Standards;
Proposed Rule." These
proposed requirements suggest standards for e-signature ordering of
prescription drugs. The
three primary requirements are message integrity, non-repudiation, and
authentication.
Message integrity means that i:he message cannot be tampered with or viewed by
non-intended
recipients. This can be fulfilled by using a secured sockets layer (SSL) in
the communication.
Non-repudiation (meaning a user cannot deny having sent the message) and
authentication
(verifying the origin of the data) are achieved by the presently disclosed
embodiment of the
invention. Thus, the present disclosed embodiment coupled with an SSL fulfills
the three
criteria of the proposed e-signature standards.
Alternative Embodiment
In an alternative embodiment, the user first visits the PVS Web site and
enters the
PVS usernarne and password. From there, the user can link directly to the
controlled access
areas of physician only Web sites with hyperlinks on the PVS site. The
hyperlinks to limited
access areas from the PVS site may be reached after logging in at the PVS site
with the PVS
username and password. These hyperlinks will then take the user directly to
the limited access
areas, without having to go through the PVS verification again.
Alternative Embodiment
In another alternative embodiment, subscribing Web site servers may retain
passwords
and usernames locally in their storage. This allows faster verification,
eliminating the need
to directly access PVS for every verification. Frequent or recent visitors to
a Web site may
be verified with the local memory of their usernames and passwords. The
subscribing Web
sites are prevented from seeing the personal data of the users either by
contract or by PVS
software stored locally designed to prevent access.
Modifications and Variations
SUBS'T1TUTE SHEET !RULE 26)
CA 02346709 2001-04-06
WO 00/27088 PGT/US99/22253
23
As will be recognized 'by those skilled in the art, the innovative concepts
described in
the present application can be modified and varied over a tremendous range of
applications,
and accordingly the scope of patented subject matter is not limited by any of
the specific
exemplary teachings given.
In the presently preferred embodiment, a method and system of physician
verification
are disclosed. However, these services will support not only marketing of
regulated products
to physicians, but also on-line Continuing Medical Education, professional
publishing on-line
for physicians, and recruitment for clinical trials. In addition, any type of
controlled access
information can make use ol" the remote verification system and method
described herein.
I 0 In the presently preferred embodiment, a proprietary encryption algorithm
is described.
However, there are many encryption schemes available such as PGP, RSA, etc.
Most if not
all of these encryption schemes can be adapted for use with the system and
method described
herein.
Optionally, secure lacking relationships (public-key relationships) can be
used to
completely prevent vendors i:rom cracking the PVS front-end software and
gaining access to
the secure data.
In another contemplated alternative, the professionals accessing a vendor site
can be
allowed to simply click on a button to give the vendor their complete
identification data.
A computer system for implementation of the presently preferred embodiment is
described. The hardware which comprises the system can be any combination of
available
processors and operating systems. Such systems can include, for example, L3nix
boxes, IBM
PC compatible, and Macintosh computer systems.
SUBSTITUTE SHEET iRULE 26)
